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1. A randomized, open-label, phase 3 trial of pembrolizumab plus epacadostat versus sunitinib or pazopanib as first-line treatment for metastatic renal cell carcinoma (KEYNOTE-679/ECHO-302).

Author

Lara, Primo, Villanueva, Luis, Ibanez, Carolina, Erman, Mustafa, Lee, Jae, Heinrich, Daniel, Lipatov, Oleg, Gedye, Craig, Gokmen, Erhan, Acevedo, Alejandro, Semenov, Andrey, Park, Se, Gafanov, Rustem, Kose, Fatih, Jones, Mark, Du, Xiaoqi, Munteanu, Mihaela, Perini, Rodolfo, Choueiri, Toni, and Motzer, Robert

Subjects
Epacadostat, IDO1, Indoleamine 2, 3-deoxygenase 1, PD-1, Pembrolizumab, Programmed death 1, Renal cell carcinoma, Humans, Carcinoma, Renal Cell, Sunitinib, Sulfonamides, Male, Female, Antibodies, Monoclonal, Humanized, Middle Aged, Pyrimidines, Antineoplastic Combined Chemotherapy Protocols, Kidney Neoplasms, Aged, Indazoles, Adult, Aged, 80 and over, Oximes
Abstract

BACKGROUND: Immunotherapy-based combinations have emerged as standard therapies for patients with metastatic renal cell carcinoma (mRCC). Pembrolizumab, a PD-1 inhibitor, combined with epacadostat, an indoleamine 2,3-deoxygenase 1 selective inhibitor, demonstrated promising antitumor activity in a phase 1 study in advanced solid tumors, including mRCC. METHODS: KEYNOTE-679/ECHO-302 was a randomized, open-label, parallel-group, multicenter, phase 3 study (NCT03260894) that compared pembrolizumab plus epacadostat with sunitinib or pazopanib as first-line treatment for mRCC. Eligible patients had histologically confirmed locally advanced or metastatic clear cell RCC and had not received systemic therapy. Patients were randomly assigned 1:1 to pembrolizumab 200 mg IV every 3 weeks plus epacadostat 100 mg orally twice daily versus sunitinib 50 mg orally once daily (4 weeks on treatment followed by 2 weeks off treatment) or pazopanib 800 mg orally once daily. Original dual primary end points were progression-free survival and overall survival. Enrollment was stopped when a phase 3 study in melanoma of pembrolizumab plus epacadostat compared with pembrolizumab monotherapy did not meet its primary end point. This protocol was amended, and primary end point was changed to investigator-assessed objective response rate (ORR) per RECIST 1.1. RESULTS: One-hundred-twenty-nine patients were randomly assigned to receive pembrolizumab plus epacadostat (n = 64) or sunitinib/pazopanib (n = 65). Median (range) follow-up, defined as time from randomization to data cutoff, was 10.3 months (2.2-14.3) and 10.3 months (2.7-13.8) in the pembrolizumab plus epacadostat and sunitinib/pazopanib arms, respectively. ORRs were similar between pembrolizumab plus epacadostat (31.3% [95% CI 20.2-44.1] and sunitinib/pazopanib (29.2% [18.6-41.8]). Grade 3-5 treatment-related adverse events occurred in 34.4% and 42.9% of patients in the pembrolizumab plus epacadostat and sunitinib/pazopanib arms, respectively. One patient in the sunitinib/pazopanib arm died of septic shock (not treatment-related). Circulating kynurenine levels decreased in the pembrolizumab plus epacadostat arm, but not to levels observed in healthy subjects. CONCLUSIONS: ORRs were similar between pembrolizumab plus epacadostat and sunitinib/pazopanib as first-line treatment in patients with mRCC. Safety and tolerability appeared similar between treatment arms; no new safety concerns were identified. Antitumor responses observed in patients with RCC receiving pembrolizumab plus epacadostat may be driven primarily by pembrolizumab. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; NCT03260894 .

Published
2024

2. Outcomes by Retrospective Eligibility for Maintenance Therapy of Patients With Advanced Urothelial Carcinoma: Post Hoc Analysis of the Phase 3 KEYNOTE-361 Trial

Author

Mamtani, Ronac, Matsubara, Nobuaki, Pino, Alvaro Montesa, Herranz, Urbano Anido, Şendur, Mehmet A． N., Gravis, Gwenaelle, Huillard, Olivier, Lee, Hyo Jin, Gafanov, Rustem, Joly, Florence, Bedke, Jens, Sella, Avishay, Chang, Yen-Hwa, Imai, Kentaro, Moreno, Blanca Homet, Xu, Jin Zhi, Alva, Ajjai, and Powles, Thomas

Published
2025
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3. Health-related Quality of Life Analysis from KEYNOTE-426: Pembrolizumab plus Axitinib Versus Sunitinib for Advanced Renal Cell Carcinoma

Author

Bedke, Jens, Rini, Brian I., Plimack, Elizabeth R., Stus, Viktor, Gafanov, Rustem, Waddell, Tom, Nosov, Dimitry, Pouliot, Frederic, Soulières, Denis, Melichar, Bohuslav, Vynnychenko, Ihor, Azevedo, Sergio J., Borchiellini, Delphine, McDermott, Raymond S., Tamada, Satoshi, Nguyen, Allison Martin, Wan, Shuyan, Perini, Rodolfo F., Rhoda Molife, L., Atkins, Michael B., and Powles, Thomas

Published
2022
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4. Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Author

Tomczak, Piotr, Choueiri, Toni, Park, Se Hoon, Venugopal, Balaji, Ferguson, Thomas R., Hajek, Jaroslav, Lin, Tzu-Ping, Symeonides, Stefan N., Lee, Jae Lyun, Sawrycki, Piotr, Haas, Naomi B., Gurney, Howard P., Mahave, Mauricio, Sarwar, Naveed, Thiery-Vuillemin, Antoine, Gross-Goupil, Marine, Chevreau, Christine, Burke, John M., Doshi, Gurjyot, Melichar, Bohuslav, Topart, Delphine, Oudard, Stephane, Kopyltsov, Evgeniy, Hammers, Hans-Joerg, Quinn, David I., Alva, Ajjai, Menezes, Juliana de Janoski, Silva, Adriano Goncalves e, Winquist, Eric W., Hamzaj, Alketa, Procopio, Giuseppe, Karaszewska, Boguslawa, Nowakowska-Zajdel, Ewa M., Alekseev, Boris Y., Gafanov, Rustem A., Izmailov, Adel, Semenov, Andrey, Afanasyev, Sergey G., Lipatov, Oleg N., Powles, Thomas B., Srinivas, Sandy, McDermott, David, Kochuparambil, Samith T., Davis, Ian D., Peltola, Katriina, Sabbatini, Roberto, Chung, Jinsoo, Shkolnik, Michail I., Matveev, Vsevolod B., Gajate Borau, Pablo, McCune, Steven, Hutson, Thomas E., Dri, Alejandro, Sales, Silvio Correia, Yeung, Carrie, Alcala Castro, Carmen Marcela, Bostrom, Peter, Laguerre, Brigitte, Buttigliero, Consuelo, de Giorgi, Ugo, Fomin, Eugeniy A., Zakharia, Yousef, Hwang, Clara, Singer, Eric A., Yorio, Jeffrey T., Waterhouse, David, Kowalyszyn, Ruben Dario, Alfie, Margarita Sonia, Yanez Ruiz, Eduardo, Buchler, Tomas, Kankaanranta, Krista, Ferretti, Gianluigi, Kimura, Go, Nishimura, Kazuo, Masumori, Naoya, Tamada, Satoshi, Kato, Haruaki, Kitamura, Hiroshi, Danielewicz, Iwona, Wojcik-Tomaszewska, Joanna, Sala Gonzalez, Nuria, Chiu, Kun-Yuan, Atkins, Michael B., Heath, Elisabeth, Rojas-Uribe, Gustavo Adolfo, Gonzalez Fernandez, Manuel Enrique, Feyerabend, Susan, Pignata, Sandro, Numakura, Kazuyuki, Cybulska Stopa, Bozena, Zukov, Ruslan, Climent Duran, Miguel Angel, Maroto Rey, Pablo Jose, Montesa Pino, Alvaro, Chang, Chao-Hsiang, Vengalil, Salil, Waddell, Tom S., Cobb, Patrick W., Hauke, Ralph, Anderson, Daniel M., Sarantopoulos, John, Gourdin, Theodore, Zhang, Tian, Jayram, Gautam, Fein, Luis Enrique, Harris, Carole, Beato, Patricia Medeiros Milhomem, Flores, Francisco, Estay, Angela, Rubiano, Juan Andres, Bedke, Jens, Hauser, Stefan, Neisius, Andreas, Busch, Jonas, Anai, Satoshi, Tsunemori, Hiroyuki, Sawka, Dariusz, Sikora-Kupis, Bozena, Arranz, Jose Angel, Delgado, Ignacio, Chen, Chung-Hsin, Gunderson, Elizabeth, Tykodi, Scott, Koletsky, Alan, Chen, Kevin, Agrawal, Manish, Kaen, Diego Lucas, Sade, Juan Pablo, Tatangelo, Marcelo Daniel, Parnis, Francis, Barbosa, Fernando Maciel, Faucher, Genevieve, Iqbal, Nayyer, Marceau, Daniele, Paradis, Jean-Benoit, Hanna, Nawar, Acevedo, Alejandro, Ibanez, Carolina, Villanueva, Luis, Galaz, Pedro Pablo, Durango, Isabel Cristina, Manneh, Ray, Kral, Zdenek, Holeckova, Petra, Hakkarainen, Heikki, Ronkainen, Hanna, Abadie-Lacourtoisie, Sophie, Tartas, Sophie, Goebell, Peter J., Grimm, Marc-Oliver, Hoefner, Thomas, Wirth, Manfred, Panic, Andrej, Schultze-Seemann, Wolfgang, Yokomizo, Akira, Mizuno, Ryuichi, Uemura, Hirotsugu, Eto, Masatoshi, Tsujihata, Masao, Matsukawa, Yoshihisa, Murakami, Yoji, Kim, Miso, Hamberg, Paul, Marczewska-Skrodzka, Malgorzata, Szczylik, Cezary, Humphreys, Alison C., Jiang, Peter, Kumar, Birendra, Lu, Gary, Desai, Arpita, Karam, Jose Antonio, Keogh, George, Fleming, Mark, Zarba, Juan Jose, Leiva, Viviana E., Mendez, Guillermo Ariel, Harris, Samuel J., Brown, Stephen J., Antonio Junior, Joao Neif, Costamilan, Rita de Cassia, Rocha, Roberto Odebrecht, Muniz, David, Brust, Leandro, Lalani, Aly-Khan, Graham, Jeffrey, Levesque, Michael, Orlandi, Francisco, Kotasek, Rostislav, Deville, Jean L., Borchiellini, Delphine, Merseburger, Axel, Rink, Michael, Roos, Frederik, McDermott, Ray, Oyama, Masafumi, Yamamoto, Yoshiaki, Tomita, Yoshihiko, Miura, Yuji, Ioritani, Naomasa, Westgeest, Hans, Kubiatowski, Tomasz, Bal, Wieslaw, Girones Sarrio, Regina, Rowe, Julie, Prow, Debra M., Senecal, Francis, Hashemi-Sadraei, Neda, Cole, Scott W., Kendall, Stephan D., Richards, Donald A., Schnadig, Ian D., Gupta, Mukul, Powles, Thomas, Ferguson, Thomas, Symeonides, Stefan N, Gurney, Howard, Chang, Yen-Hwa, Haas, Naomi B, Burgents, Joseph E, Xu, Lei, Imai, Kentaro, Quinn, David I, and Choueiri, Toni K

Published
2022
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5. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial

Author

Parnis, Francis, Joshua, Anthony M., Horvath, Lisa G., Steer, Christopher, Marx, Gavin, Sandhu, Shahneen, Gurney, Howard, Ferguson, Thomas, Van Bruwaene, Siska, Luyten, Daisy, Schatteman, Peter, Lumen, Nicolaas, Dirix, Luc, Goeminne, Jean-Charles, Gil, Thierry, Seront, Emmanuel, Vulsteke, Christof, Kussumoto, Celio, Franke, Fabio A., Martinelli de Oliveira, Fabricio Augusto, Pereira de Santana Gomes, Andrea Juliana, Pinczowski, Hélio, Preto, Daniel D'Almeida, Zucca, Luis Eduardo, Borges, Giuliano Santos, Murad, Andre M., Saad, Fred, Chi, Kim N., Fradet, Yves, Fleshner, Neil E., Emmenegger, Urban, Brasso, Klaus, Fizazi, Karim, Culine, Stephane, Thiery-Vuillemin, Antoine, Joly, Florence, Fléchon, Aude, Hilgers, Werner, Eymard, Jean-Christophe, Borchiellini, Delphine, Barthélémy, Philippe, Berger, Raanan, Leibowitz-Amit, Raya, Mermershtain, Wilmosh, Rouvinov, Keren, Peer, Avivit, Kovel, Svetlana, Sella, Avishay, Lolkema, Martijn P., van den Eertwegh, Alfonsus J.M., Voortman, Johannes, Aarts, Maureen J., Gietema, Jourik A., Kim, Choung-Soo, Choi, Young-Deuk, Chung, Byung-Ha, Gafanov, Rustem A., Kopyltsov, Evgeniy, Usynin, Evgeny A., Carles, Joan, Mellado, Begoña, Maroto, José Pablo, García-Donás, Jesús, Rodríguez Moreno, Juan Francisco, Durán, Ignacio, Pérez-Valderrama, Begoña, Castro, Elena, Olmos, David, Méndez-Vidal, María José, Estellés, David Lorente, Sarrió, Regina Gironés, Muñoz-Langa, José, Herranz, Urbano Anido, Puente Vázquez, Javier, Castellanos, Enrique, Hellström, Martin, Widmark, Anders, Lissbrant, Ingela Franck, Jellvert, Åsa, Külich, Cecilia, Blom, René, Ståhl, Olof, Chiang, Po-Hui, Kang, Chih-Hsiung, Ou, Yen-Chuan, Wang, Shian-Shiang, Wu, Hsi-Chin, Lu, Yu-Chuan, Attard, Gerhardt, Khoo, Vincent, Bahl, Amit, Kellati, Prasad, Parikh, Omi, Srinivasan, Rajaguru, Lester, Jason F., Staffurth, John N., Cheng, Heather H., Efstathiou, Eleni, Pilié, Patrick G., George, Daniel J., Karsh, Lawrence I., Kelly, W. Kevin, Danila, Daniel C., Sieber, Paul R., Smith, Matthew R., Heath, Elisabeth I., Vaishampayan, Ulka N., Flaig, Thomas W., Emamekhoo, Hamid, Pinski, Jacek K., Kalebasty, Arash Rezazadeh, Maly, Joseph J., Moon, Helen, Smith, Matthew R, Scher, Howard I, Lara, Primo N, Jr, Yu, Evan Y, George, Daniel J, Chi, Kim N, Danila, Daniel C, Mason, Gary E, Espina, Byron M, Zhao, Xin, Urtishak, Karen A, Francis, Peter, and Lopez-Gitlitz, Angela

Published
2022
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6. Biomarker analysis of the phase 3 KEYNOTE-426 study of pembrolizumab (P) plus axitinib (A) versus sunitinib (S) for advanced renal cell carcinoma (RCC).

Author

Rini, Brian I., primary, Plimack, Elizabeth R., additional, Stus, Viktor, additional, Gafanov, Rustem, additional, Waddell, Tom, additional, Nosov, Dmitry, additional, Pouliot, Frederic, additional, Alekseev, Boris, additional, Soulieres, Denis, additional, Azevedo, Sergio Jobim, additional, Borchiellini, Delphine, additional, McDermott, Raymond S., additional, Perini, Rodolfo F., additional, Markensohn, Julia, additional, Molife, L. Rhoda, additional, Zhang, Yiwei, additional, Nebozhyn, Michael, additional, Loboda, Andrey, additional, Vajdi, Amir, additional, and Powles, Thomas, additional

Published
2024
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7. Ipatasertib plus abiraterone and prednisolone in metastatic castration-resistant prostate cancer (IPATential150): a multicentre, randomised, double-blind, phase 3 trial

Author

Sweeney, Christopher, Bracarda, Sergio, Sternberg, Cora N, Chi, Kim N, Olmos, David, Sandhu, Shahneen, Massard, Christophe, Matsubara, Nobuaki, Alekseev, Boris, Parnis, Francis, Atduev, Vagif, Buchschacher, Gary L, Jr, Gafanov, Rustem, Corrales, Luis, Borre, Michael, Stroyakovskiy, Daniil, Alves, Gustavo Vasconcelos, Bournakis, Evangelos, Puente, Javier, Harle-Yge, Marie-Laurence, Gallo, Jorge, Chen, Geng, Hanover, Justin, Wongchenko, Matthew J, Garcia, Josep, and de Bono, Johann S

Published
2021
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8. Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial

Author

Cascallar, Diana Vera, Varela, Mirta, Lazzaro, Mauricio Fernandez, Kaen, Diego Lucas, Gatica, Gabriela, Flores, David Hugo, Falco, Agustin, Molina, Matias, Van Aelst, Filip, Vulsteke, Christof, Sautois, Brieuc, Machiels, Jean-Pascal, Schallier, Denis, Brust, Leandro, Rapatoni, Liane, Azevedo, Sergio J, Marinho, Gisele, Soares, Joao Paulo Holanda, Dzik, Carlos, Almeida Silva, Jamile, Fay, Andre Poisl, Gingerich, Joel, Fradet, Yves, Ferrario, Cristiano, Potvin, Kylea, Vanhuyse, Marie, Abdelsalam, Mahmoud, Cheng, Susanna, Caglevic, Christian, Reyes, Felipe, Leal, Jose Luis, Francisco, Francisco, Ibanez, Carolina, Joly, Florence, Laguerre, Brigitte, Ladoire, Sylvain, Flechon, Aude, Topart, Delphine, Huillard, Olivier, Oudard, Stéphane, Gross-Goupil, Marine, Culine, Stephane, Loriot, Yohann, Gravis, Gwenaelle, Reichardt, Peter, Retz, Margitta, Herden, Jan, Pfister, David, Ohlman, Carsten, Stoeckle, Michael, Wirth, Manfred, Lorch, Anja, Niegisch, Guenter, Goebell, Peter J, Boegemann, Martin, Merseburger, Axel, Gakis, Georgios, Bedke, Jens, Neisius, Andreas, Thomas, Christian, Hoefner, Thomas, Telekes, Andras, Kosa, Judit Erzsebet, Revesz, Janos, Bodoky, Gyorgy, Csoszi, Tibor, Csejtei, Andras, Geczi, Lajos, Ruzsa, Agnes, Kolonics, Zsuzsanna, Erfan, Jozsef, McDermott, Ray, Bambury, Richard, Sella, Avishay, Frank, Stephen Jay, Kejzman, Daniel, Goldman, Olesya, Rosenbaum, Eli, Peer, Avivit, Berger, Raanan, Rouvinov, Keren, Sarid, David, Fukasawa, Satoshi, Arai, Gaku, Yamaguchi, Akito, Yokomizo, Akira, Takayama, Tatsuya, Kinoshita, Hidefumi, Kikuchi, Eiji, Mizuno, Ryuichi, Fujii, Yasuhisa, Sassa, Naoto, Matsukawa, Yoshihisa, Fujimoto, Kiyohide, Matsubara, Nobuaki, Tanikawa, Toshiki, Tomita, Yoshihiko, Nishimura, Kazuo, Tsujihata, Masao, Oyama, Masafumi, Masumori, Naoya, Kanayama, Hiroomi, Takano, Toshimi, Miura, Yuji, Miyazaki, Jun, Joraku, Akira, Kimura, Tomokazu, Yamamoto, Yoshiaki, Kobayashi, Kazuki, De Wit, Ronald, Aarts, Maureen, Gerritsen, Winald, Los, Maartje, Beerepoot, Laurens, Izmailov, Adel, Gorelov, Sergey Igorevich, Alekseev, Boris Yakovlevich, Semenov, Andrey, Kostorov, Vladimir Anatolyevich, Alekseev, Sergey M, Zyryanov, Alexander, Oschepkov, Vasiliy Nikolaevich, Shidin, Vladimir Aleksandrovich, Vladimirov, Vladimir Ivanovich, Gafanov, Rustem Airatovich, Karlov, Petr Alexandrovich, Anderson, David Brian, Shepherd, Lucinda, Cohen, Graham Lawrence, Rapoport, Bernardo Louis, Ruff, Paul, Lee, Nari, Bae, Woo Kyun, Lee, Hyo Jin, Herranz, Urbano Anido, Rodriguez-Vida, Alejo, Morales Barrera, Rafael, Grande, Enrique, Alonso Gordoa, Teresa, Guma Padro, Josep, Gauna, Daniel Castellano, Arranz, Jose Angel, Munoz Langa, Jose, Sarrio, Regina Girones, Montesa Pino, Alvaro, Juan Fita, Maria Jose, Su, Yu-Li, Lin, Yung-Chang, Su, Wen-Pin, Shen, Ying-Chun, Chang, Yen-Hwa, Huang, Yi-Hsiu, Sriuranpong, Virote, Chansriwong, Phichai, Srimuninnimit, Vichien, Danchaivijitr, Pongwut, Abali, Huseyin, Yavuz, Sinan, Ozyilkan, Ozgur, Sendur, Mehmet Ali Nahit, Ekenel, Meltem, Ozguroglu, Mustafa, Arslan, Cagatay, Gunduz, Seyda, Ozdogan, Mustafa, Birtle, Alison, Powles, Thomas, Huddart, Robert, de Santis, Maria, Zarkar, Anjali, Evans, Linda, Hussain, Syed, DiSimone, Christopher, Muina, Antonio F, Schlegel, Peter, Jhangiani, Haresh S, Harrison, Michael, Slater, Dennis E, Wright, David, Percent, Ivor J, Lin, Jianqing, Hwang, Clara, Mamtani, Ronac, Gupta, Sumati, Bajaj, Madhuri, Galamaga, Robert, Eklund, John, Wallace, James, Shtivelband, Mikhail, Suh, Jason Jung-Gon, Burhani, Nafisa, Eadens, Matthew, Gunturu, Krishna, Burgess, Earle, Wong, John, Chaudhry, Arvind, Van Veldhuizen, Peter, Graff, Stephanie, Thomas, Christian A, Schnadig, Ian D, Carneiro, Benedito, Hussain, Maha, Morgans, Alicia, Fitzharris, John T, Oliff, Ira A, Vuky, Jacqueline, Hauke, Ralph, Baron, Ari, Joshi, Monika, Bolemon, Britt H, Jiang, Peter, Mega, Anthony E, Markus, Maurice, Pfanzelter, Nicklas, Lawler, William Eyre, Cobb, Patrick Wayne, Courtright, Jay G, Jain, Sharad, Doshi, Gurjyot, Gunuganti, Vijay K, Sartor, Oliver Alton, Cole, Scott W, Babiker, Hani, Uchio, Edward M, Drakaki, Alexandra, Mannuel, Heather D, Alva, Ajjai, Guancial, Elizabeth, Fung, Chunkit, Charles, Anthony, Amato, Robert J, Arriaga, Yull, Bowman, Isaac, Ades, Steven, Dreicer, Robert, Yu, Evan, Quinn, David I, Fleming, Mark, Csőszi, Tibor, Özgüroğlu, Mustafa, Géczi, Lajos, Cheng, Susanna Y-S, Oudard, Stephane, Fléchon, Aude, Yu, Evan Y, Nam, Kijoeng, Imai, Kentaro, and Homet Moreno, Blanca

Published
2021
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9. Pembrolizumab plus axitinib versus sunitinib monotherapy as first-line treatment of advanced renal cell carcinoma (KEYNOTE-426): extended follow-up from a randomised, open-label, phase 3 trial

Author

Powles, Thomas, Plimack, Elizabeth R, Soulières, Denis, Waddell, Tom, Stus, Viktor, Gafanov, Rustem, Nosov, Dmitry, Pouliot, Frédéric, Melichar, Bohuslav, Vynnychenko, Ihor, Azevedo, Sergio J, Borchiellini, Delphine, McDermott, Raymond S, Bedke, Jens, Tamada, Satoshi, Yin, Lina, Chen, Mei, Molife, L Rhoda, Atkins, Michael B, and Rini, Brian I

Published
2020
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11. Pembrolizumab Plus Axitinib Versus Sunitinib as First-line Treatment of Advanced Renal Cell Carcinoma: 43-month Follow-up of the Phase 3 KEYNOTE-426 Study

Author

Plimack, Elizabeth R., primary, Powles, Thomas, additional, Stus, Viktor, additional, Gafanov, Rustem, additional, Nosov, Dmitry, additional, Waddell, Tom, additional, Alekseev, Boris, additional, Pouliot, Frédéric, additional, Melichar, Bohuslav, additional, Soulières, Denis, additional, Borchiellini, Delphine, additional, McDermott, Raymond S., additional, Vynnychenko, Ihor, additional, Chang, Yen-Hwa, additional, Tamada, Satoshi, additional, Atkins, Michael B., additional, Li, Chenxiang, additional, Perini, Rodolfo, additional, Molife, L. Rhoda, additional, Bedke, Jens, additional, and Rini, Brian I., additional

Published
2023
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12. Corrigendum to “Pembrolizumab Plus Axitinib Versus Sunitinib as First-line Treatment of Advanced Renal Cell Carcinoma: 43-month Follow-up of the Phase 3 KEYNOTE-426 Study” [Eur. Urol. (2023)]

Author

Plimack, Elizabeth R., primary, Powles, Thomas, additional, Stus, Viktor, additional, Gafanov, Rustem, additional, Nosov, Dmitry, additional, Waddell, Tom, additional, Alekseev, Boris, additional, Pouliot, Frédéric, additional, Melichar, Bohuslav, additional, Soulières, Denis, additional, Borchiellini, Delphine, additional, McDermott, Raymond S., additional, Vynnychenko, Ihor, additional, Chang, Yen-Hwa, additional, Tamada, Satoshi, additional, Atkins, Michael B., additional, Li, Chenxiang, additional, Perini, Rodolfo, additional, Rhoda Molife, L., additional, Bedke, Jens, additional, and Rini, Brian I., additional

Published
2023
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13. Health-related quality of life in GALAHAD: A multicenter, open-label, phase 2 study of niraparib for patients with metastatic castration-resistant prostate cancer and DNA-repair gene defects

Author

Smith, Matthew R, primary, Sandhu, Shahneen, additional, George, Daniel J, additional, Chi, Kim Nguyen, additional, Saad, Fred, additional, Thiery-Vuillemin, Antoine, additional, Stàhl, Olaf, additional, Olmos, David, additional, Danila, Daniel C, additional, Gafanov, Rustem, additional, Castro, Elena, additional, Moon, Helen, additional, Joshua, Anthony M, additional, Mason, Gary E, additional, Espina, Byron M, additional, Liu, Yan, additional, Lopez-Gitlitz, Angela, additional, Francis, Peter, additional, Bevans, Katherine B, additional, and Fizazi, Karim, additional

Published
2023
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14. Pembrolizumab plus docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC): Randomized, double-blind, phase 3 KEYNOTE-921 study.

Author

Petrylak, Daniel P., primary, Ratta, Raffaele, additional, Matsubara, Nobuaki, additional, Korbenfeld, Ernesto Pablo, additional, Gafanov, Rustem, additional, Mourey, Loic, additional, Todenhöfer, Tilman, additional, Gurney, Howard, additional, Kramer, Gero, additional, Bergman, Andre M., additional, Zalewski, Pawel, additional, De Santis, Maria, additional, Armstrong, Andrew J., additional, Gerritsen, Winald R., additional, Pachynski, Russell Kent, additional, Byun, Seok-Soo, additional, Li, Xin Tong, additional, Schloss, Charles, additional, Poehlein, Christian Heinrich, additional, and Fizazi, Karim, additional

Published
2023
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15. Patient-reported outcomes (PROs) in KEYNOTE-921: Pembrolizumab (pembro) plus docetaxel for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).

Author

Petrylak, Daniel P., primary, Ratta, Raffaele, additional, Matsubara, Nobuaki, additional, Korbenfeld, Ernesto Pablo, additional, Gafanov, Rustem, additional, Mourey, Loic, additional, Todenhöfer, Tilman, additional, Gurney, Howard, additional, Kramer, Gero, additional, Bergman, Andre M., additional, Zalewski, Pawel, additional, De Santis, Maria, additional, Armstrong, Andrew J., additional, Gerritsen, Winald R., additional, Pachynski, Russell Kent, additional, Saretsky, Todd L., additional, Ghate, Sameer R., additional, Li, Xin Tong, additional, Schloss, Charles, additional, and Fizazi, Karim, additional

Published
2023
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16. Pembrolizumab Plus Olaparib for Patients With Previously Treated and Biomarker-Unselected Metastatic Castration-Resistant Prostate Cancer: The Randomized, Open-Label, Phase III KEYLYNK-010 Trial.

Author

Antonarakis, Emmanuel S., Park, Se Hoon, Goh, Jeffrey C., Shin, Sang Joon, Lee, Jae Lyun, Mehra, Niven, McDermott, Ray, Sala-Gonzalez, Núria, Fong, Peter C., Greil, Richard, Retz, Margitta, Sade, Juan Pablo, Yanez, Patricio, Huang, Yi-Hsiu, Begbie, Stephen D., Gafanov, Rustem Airatovich, De Santis, Maria, Rosenbaum, Eli, Kolinsky, Michael P., and Rey, Felipe

Published
2023
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17. Pembrolizumab versus placebo as post-nephrectomy adjuvant therapy for clear cell renal cell carcinoma (KEYNOTE-564): 30-month follow-up analysis of a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Author

Powles, Thomas, primary, Tomczak, Piotr, additional, Park, Se Hoon, additional, Venugopal, Balaji, additional, Ferguson, Thomas, additional, Symeonides, Stefan N, additional, Hajek, Jaroslav, additional, Gurney, Howard, additional, Chang, Yen-Hwa, additional, Lee, Jae Lyun, additional, Sarwar, Naveed, additional, Thiery-Vuillemin, Antoine, additional, Gross-Goupil, Marine, additional, Mahave, Mauricio, additional, Haas, Naomi B, additional, Sawrycki, Piotr, additional, Burgents, Joseph E, additional, Xu, Lei, additional, Imai, Kentaro, additional, Quinn, David I, additional, Choueiri, Toni K, additional, Choueiri, Toni, additional, Ferguson, Thomas R., additional, Lin, Tzu-Ping, additional, Symeonides, Stefan N., additional, Haas, Naomi B., additional, Gurney, Howard P., additional, Chevreau, Christine, additional, Burke, John M., additional, Doshi, Gurjyot, additional, Melichar, Bohuslav, additional, Topart, Delphine, additional, Oudard, Stephane, additional, Kopyltsov, Evgeniy, additional, Hammers, Hans-Joerg, additional, Quinn, David I., additional, Alva, Ajjai, additional, Menezes, Juliana de Janoski, additional, Silva, Adriano Goncalves e, additional, Winquist, Eric W., additional, Hamzaj, Alketa, additional, Procopio, Giuseppe, additional, Karaszewska, Boguslawa, additional, Nowakowska-Zajdel, Ewa M., additional, Alekseev, Boris Y., additional, Gafanov, Rustem A., additional, Izmailov, Adel, additional, Semenov, Andrey, additional, Afanasyev, Sergey G., additional, Lipatov, Oleg N., additional, Powles, Thomas B., additional, Srinivas, Sandy, additional, McDermott, David, additional, Kochuparambil, Samith T., additional, Davis, Ian D., additional, Peltola, Katriina, additional, Sabbatini, Roberto, additional, Chung, Jinsoo, additional, Shkolnik, Michail I., additional, Matveev, Vsevolod B., additional, Gajate Borau, Pablo, additional, McCune, Steven, additional, Hutson, Thomas E., additional, Dri, Alejandro, additional, Sales, Silvio Correia, additional, Yeung, Carrie, additional, Alcala Castro, Carmen Marcela, additional, Bostrom, Peter, additional, Laguerre, Brigitte, additional, Buttigliero, Consuelo, additional, de Giorgi, Ugo, additional, Fomin, Eugeniy A., additional, Zakharia, Yousef, additional, Hwang, Clara, additional, Singer, Eric A., additional, Yorio, Jeffrey T., additional, Waterhouse, David, additional, Kowalyszyn, Ruben Dario, additional, Alfie, Margarita Sonia, additional, Yanez Ruiz, Eduardo, additional, Buchler, Tomas, additional, Kankaanranta, Krista, additional, Ferretti, Gianluigi, additional, Kimura, Go, additional, Nishimura, Kazuo, additional, Masumori, Naoya, additional, Tamada, Satoshi, additional, Kato, Haruaki, additional, Kitamura, Hiroshi, additional, Danielewicz, Iwona, additional, Wojcik-Tomaszewska, Joanna, additional, Sala Gonzalez, Nuria, additional, Chiu, Kun-Yuan, additional, Atkins, Michael B., additional, Heath, Elisabeth, additional, Rojas-Uribe, Gustavo Adolfo, additional, Gonzalez Fernandez, Manuel Enrique, additional, Feyerabend, Susan, additional, Pignata, Sandro, additional, Numakura, Kazuyuki, additional, Cybulska Stopa, Bozena, additional, Zukov, Ruslan, additional, Climent Duran, Miguel Angel, additional, Maroto Rey, Pablo Jose, additional, Montesa Pino, Alvaro, additional, Chang, Chao-Hsiang, additional, Vengalil, Salil, additional, Waddell, Tom S., additional, Cobb, Patrick W., additional, Hauke, Ralph, additional, Anderson, Daniel M., additional, Sarantopoulos, John, additional, Gourdin, Theodore, additional, Zhang, Tian, additional, Jayram, Gautam, additional, Fein, Luis Enrique, additional, Harris, Carole, additional, Beato, Patricia Medeiros Milhomem, additional, Flores, Francisco, additional, Estay, Angela, additional, Rubiano, Juan Andres, additional, Bedke, Jens, additional, Hauser, Stefan, additional, Neisius, Andreas, additional, Busch, Jonas, additional, Anai, Satoshi, additional, Tsunemori, Hiroyuki, additional, Sawka, Dariusz, additional, Sikora-Kupis, Bozena, additional, Arranz, Jose Angel, additional, Delgado, Ignacio, additional, Chen, Chung-Hsin, additional, Gunderson, Elizabeth, additional, Tykodi, Scott, additional, Koletsky, Alan, additional, Chen, Kevin, additional, Agrawal, Manish, additional, Kaen, Diego Lucas, additional, Sade, Juan Pablo, additional, Tatangelo, Marcelo Daniel, additional, Parnis, Francis, additional, Barbosa, Fernando Maciel, additional, Faucher, Genevieve, additional, Iqbal, Nayyer, additional, Marceau, Daniele, additional, Paradis, Jean-Benoit, additional, Hanna, Nawar, additional, Acevedo, Alejandro, additional, Ibanez, Carolina, additional, Villanueva, Luis, additional, Galaz, Pedro Pablo, additional, Durango, Isabel Cristina, additional, Manneh, Ray, additional, Kral, Zdenek -, additional, Holeckova, Petra, additional, Hakkarainen, Heikki, additional, Ronkainen, Hanna, additional, Abadie-Lacourtoisie, Sophie, additional, Tartas, Sophie, additional, Goebell, Peter J., additional, Grimm, Marc-Oliver, additional, Hoefner, Thomas, additional, Wirth, Manfred, additional, Panic, Andrej, additional, Schultze-Seemann, Wolfgang, additional, Yokomizo, Akira, additional, Mizuno, Ryuichi, additional, Uemura, Hirotsugu, additional, Eto, Masatoshi, additional, Tsujihata, Masao, additional, Matsukawa, Yoshihisa, additional, Murakami, Yoji, additional, Kim, Miso, additional, Hamberg, Paul, additional, Marczewska-Skrodzka, Malgorzata, additional, Szczylik, Cezary, additional, Humphreys, Alison C., additional, Jiang, Peter, additional, Kumar, Birendra, additional, Lu, Gary, additional, Desai, Arpita, additional, Karam, Jose Antonio, additional, Keogh, George, additional, Fleming, Mark, additional, Zarba, Juan Jose, additional, Leiva, Viviana E., additional, Mendez, Guillermo Ariel, additional, Harris, Samuel J., additional, Brown, Stephen J., additional, Antonio Junior, Joao Neif, additional, Costamilan, Rita de Cassia, additional, Rocha, Roberto Odebrecht, additional, Muniz, David, additional, Brust, Leandro, additional, Lalani, Aly-Khan, additional, Graham, Jeffrey, additional, Levesque, Michael, additional, Orlandi, Francisco, additional, Kotasek, Rostislav, additional, Deville, Jean L., additional, Borchiellini, Delphine, additional, Merseburger, Axel, additional, Rink, Michael, additional, Roos, Frederik, additional, McDermott, Ray, additional, Oyama, Masafumi, additional, Yamamoto, Yoshiaki, additional, Tomita, Yoshihiko, additional, Miura, Yuji, additional, Ioritani, Naomasa, additional, Westgeest, Hans, additional, Kubiatowski, Tomasz, additional, Bal, Wieslaw, additional, Girones Sarrio, Regina, additional, Rowe, Julie, additional, Prow, Debra M., additional, Senecal, Francis, additional, Hashemi-Sadraei, Neda, additional, Cole, Scott W., additional, Kendall, Stephan D., additional, Richards, Donald A., additional, Schnadig, Ian D., additional, and Gupta, Mukul, additional

Published
2022
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19. Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma (ccRCC): Analysis of progression after first subsequent therapy in KEYNOTE-426.

Author

Powles, Thomas, primary, Plimack, Elizabeth R., additional, Stus, Viktor, additional, Waddell, Tom, additional, Gafanov, Rustem, additional, Pouliot, Frédéric, additional, Nosov, Dmitry, additional, Melichar, Bohuslav, additional, Soulieres, Denis, additional, Borchiellini, Delphine, additional, Vynnychenko, Ihor, additional, McDermott, Raymond S., additional, Azevedo, Sergio Jobim, additional, Tamada, Satoshi, additional, Kryzhanivska, Anna, additional, Li, Chenxiang, additional, Burgents, Joseph E., additional, Molife, L. Rhoda, additional, Rini, Brian I., additional, and Bedke, Jens, additional

Published
2022
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20. Niraparib in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects (GALAHAD): a multicentre, open-label, phase 2 trial

Author

Smith, Matthew R, primary, Scher, Howard I, additional, Sandhu, Shahneen, additional, Efstathiou, Eleni, additional, Lara, Primo N, additional, Yu, Evan Y, additional, George, Daniel J, additional, Chi, Kim N, additional, Saad, Fred, additional, Ståhl, Olof, additional, Olmos, David, additional, Danila, Daniel C, additional, Mason, Gary E, additional, Espina, Byron M, additional, Zhao, Xin, additional, Urtishak, Karen A, additional, Francis, Peter, additional, Lopez-Gitlitz, Angela, additional, Fizazi, Karim, additional, Parnis, Francis, additional, Joshua, Anthony M., additional, Horvath, Lisa G., additional, Steer, Christopher, additional, Marx, Gavin, additional, Gurney, Howard, additional, Ferguson, Thomas, additional, Van Bruwaene, Siska, additional, Luyten, Daisy, additional, Schatteman, Peter, additional, Lumen, Nicolaas, additional, Dirix, Luc, additional, Goeminne, Jean-Charles, additional, Gil, Thierry, additional, Seront, Emmanuel, additional, Vulsteke, Christof, additional, Kussumoto, Celio, additional, Franke, Fabio A., additional, Martinelli de Oliveira, Fabricio Augusto, additional, Pereira de Santana Gomes, Andrea Juliana, additional, Pinczowski, Hélio, additional, Preto, Daniel D'Almeida, additional, Zucca, Luis Eduardo, additional, Borges, Giuliano Santos, additional, Murad, Andre M., additional, Chi, Kim N., additional, Fradet, Yves, additional, Fleshner, Neil E., additional, Emmenegger, Urban, additional, Brasso, Klaus, additional, Culine, Stephane, additional, Thiery-Vuillemin, Antoine, additional, Joly, Florence, additional, Fléchon, Aude, additional, Hilgers, Werner, additional, Eymard, Jean-Christophe, additional, Borchiellini, Delphine, additional, Barthélémy, Philippe, additional, Berger, Raanan, additional, Leibowitz-Amit, Raya, additional, Mermershtain, Wilmosh, additional, Rouvinov, Keren, additional, Peer, Avivit, additional, Kovel, Svetlana, additional, Sella, Avishay, additional, Lolkema, Martijn P., additional, van den Eertwegh, Alfonsus J.M., additional, Voortman, Johannes, additional, Aarts, Maureen J., additional, Gietema, Jourik A., additional, Kim, Choung-Soo, additional, Choi, Young-Deuk, additional, Chung, Byung-Ha, additional, Gafanov, Rustem A., additional, Kopyltsov, Evgeniy, additional, Usynin, Evgeny A., additional, Carles, Joan, additional, Mellado, Begoña, additional, Maroto, José Pablo, additional, García-Donás, Jesús, additional, Rodríguez Moreno, Juan Francisco, additional, Durán, Ignacio, additional, Pérez-Valderrama, Begoña, additional, Castro, Elena, additional, Méndez-Vidal, María José, additional, Estellés, David Lorente, additional, Sarrió, Regina Gironés, additional, Muñoz-Langa, José, additional, Herranz, Urbano Anido, additional, Puente Vázquez, Javier, additional, Castellanos, Enrique, additional, Hellström, Martin, additional, Widmark, Anders, additional, Lissbrant, Ingela Franck, additional, Jellvert, Åsa, additional, Külich, Cecilia, additional, Blom, René, additional, Chiang, Po-Hui, additional, Kang, Chih-Hsiung, additional, Ou, Yen-Chuan, additional, Wang, Shian-Shiang, additional, Wu, Hsi-Chin, additional, Lu, Yu-Chuan, additional, Attard, Gerhardt, additional, Khoo, Vincent, additional, Bahl, Amit, additional, Kellati, Prasad, additional, Parikh, Omi, additional, Srinivasan, Rajaguru, additional, Lester, Jason F., additional, Staffurth, John N., additional, Cheng, Heather H., additional, Pilié, Patrick G., additional, George, Daniel J., additional, Karsh, Lawrence I., additional, Kelly, W. Kevin, additional, Danila, Daniel C., additional, Sieber, Paul R., additional, Smith, Matthew R., additional, Heath, Elisabeth I., additional, Vaishampayan, Ulka N., additional, Flaig, Thomas W., additional, Emamekhoo, Hamid, additional, Pinski, Jacek K., additional, Kalebasty, Arash Rezazadeh, additional, Maly, Joseph J., additional, and Moon, Helen, additional

Published
2022
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21. Corrigendum to “Pembrolizumab Plus Axitinib Versus Sunitinib as First-line Treatment of Advanced Renal Cell Carcinoma: 43-month Follow-up of the Phase 3 KEYNOTE-426 Study” [Eur Urol 84(5) (2023) 449–454]

Author

Plimack, Elizabeth R., Powles, Thomas, Stus, Viktor, Gafanov, Rustem, Nosov, Dmitry, Waddell, Tom, Alekseev, Boris, Pouliot, Frédéric, Melichar, Bohuslav, Soulières, Denis, Borchiellini, Delphine, McDermott, Raymond S., Vynnychenko, Ihor, Chang, Yen-Hwa, Tamada, Satoshi, Atkins, Michael B., Li, Chenxiang, Perini, Rodolfo, Molife, L. Rhoda, Bedke, Jens, and Rini, Brian I.

Published
2024
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23. Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial

Author

Powles, Thomas, primary, Csőszi, Tibor, additional, Özgüroğlu, Mustafa, additional, Matsubara, Nobuaki, additional, Géczi, Lajos, additional, Cheng, Susanna Y-S, additional, Fradet, Yves, additional, Oudard, Stephane, additional, Vulsteke, Christof, additional, Morales Barrera, Rafael, additional, Fléchon, Aude, additional, Gunduz, Seyda, additional, Loriot, Yohann, additional, Rodriguez-Vida, Alejo, additional, Mamtani, Ronac, additional, Yu, Evan Y, additional, Nam, Kijoeng, additional, Imai, Kentaro, additional, Homet Moreno, Blanca, additional, Alva, Ajjai, additional, Cascallar, Diana Vera, additional, Varela, Mirta, additional, Lazzaro, Mauricio Fernandez, additional, Kaen, Diego Lucas, additional, Gatica, Gabriela, additional, Flores, David Hugo, additional, Falco, Agustin, additional, Molina, Matias, additional, Van Aelst, Filip, additional, Sautois, Brieuc, additional, Machiels, Jean-Pascal, additional, Schallier, Denis, additional, Brust, Leandro, additional, Rapatoni, Liane, additional, Azevedo, Sergio J, additional, Marinho, Gisele, additional, Soares, Joao Paulo Holanda, additional, Dzik, Carlos, additional, Almeida Silva, Jamile, additional, Fay, Andre Poisl, additional, Gingerich, Joel, additional, Ferrario, Cristiano, additional, Potvin, Kylea, additional, Vanhuyse, Marie, additional, Abdelsalam, Mahmoud, additional, Cheng, Susanna, additional, Caglevic, Christian, additional, Reyes, Felipe, additional, Leal, Jose Luis, additional, Francisco, Francisco, additional, Ibanez, Carolina, additional, Joly, Florence, additional, Laguerre, Brigitte, additional, Ladoire, Sylvain, additional, Flechon, Aude, additional, Topart, Delphine, additional, Huillard, Olivier, additional, Oudard, Stéphane, additional, Gross-Goupil, Marine, additional, Culine, Stephane, additional, Gravis, Gwenaelle, additional, Reichardt, Peter, additional, Retz, Margitta, additional, Herden, Jan, additional, Pfister, David, additional, Ohlman, Carsten, additional, Stoeckle, Michael, additional, Wirth, Manfred, additional, Lorch, Anja, additional, Niegisch, Guenter, additional, Goebell, Peter J, additional, Boegemann, Martin, additional, Merseburger, Axel, additional, Gakis, Georgios, additional, Bedke, Jens, additional, Neisius, Andreas, additional, Thomas, Christian, additional, Hoefner, Thomas, additional, Telekes, Andras, additional, Kosa, Judit Erzsebet, additional, Revesz, Janos, additional, Bodoky, Gyorgy, additional, Csoszi, Tibor, additional, Csejtei, Andras, additional, Geczi, Lajos, additional, Ruzsa, Agnes, additional, Kolonics, Zsuzsanna, additional, Erfan, Jozsef, additional, McDermott, Ray, additional, Bambury, Richard, additional, Sella, Avishay, additional, Frank, Stephen Jay, additional, Kejzman, Daniel, additional, Goldman, Olesya, additional, Rosenbaum, Eli, additional, Peer, Avivit, additional, Berger, Raanan, additional, Rouvinov, Keren, additional, Sarid, David, additional, Fukasawa, Satoshi, additional, Arai, Gaku, additional, Yamaguchi, Akito, additional, Yokomizo, Akira, additional, Takayama, Tatsuya, additional, Kinoshita, Hidefumi, additional, Kikuchi, Eiji, additional, Mizuno, Ryuichi, additional, Fujii, Yasuhisa, additional, Sassa, Naoto, additional, Matsukawa, Yoshihisa, additional, Fujimoto, Kiyohide, additional, Tanikawa, Toshiki, additional, Tomita, Yoshihiko, additional, Nishimura, Kazuo, additional, Tsujihata, Masao, additional, Oyama, Masafumi, additional, Masumori, Naoya, additional, Kanayama, Hiroomi, additional, Takano, Toshimi, additional, Miura, Yuji, additional, Miyazaki, Jun, additional, Joraku, Akira, additional, Kimura, Tomokazu, additional, Yamamoto, Yoshiaki, additional, Kobayashi, Kazuki, additional, De Wit, Ronald, additional, Aarts, Maureen, additional, Gerritsen, Winald, additional, Los, Maartje, additional, Beerepoot, Laurens, additional, Izmailov, Adel, additional, Gorelov, Sergey Igorevich, additional, Alekseev, Boris Yakovlevich, additional, Semenov, Andrey, additional, Kostorov, Vladimir Anatolyevich, additional, Alekseev, Sergey M, additional, Zyryanov, Alexander, additional, Oschepkov, Vasiliy Nikolaevich, additional, Shidin, Vladimir Aleksandrovich, additional, Vladimirov, Vladimir Ivanovich, additional, Gafanov, Rustem Airatovich, additional, Karlov, Petr Alexandrovich, additional, Anderson, David Brian, additional, Shepherd, Lucinda, additional, Cohen, Graham Lawrence, additional, Rapoport, Bernardo Louis, additional, Ruff, Paul, additional, Lee, Nari, additional, Bae, Woo Kyun, additional, Lee, Hyo Jin, additional, Herranz, Urbano Anido, additional, Grande, Enrique, additional, Alonso Gordoa, Teresa, additional, Guma Padro, Josep, additional, Gauna, Daniel Castellano, additional, Arranz, Jose Angel, additional, Munoz Langa, Jose, additional, Sarrio, Regina Girones, additional, Montesa Pino, Alvaro, additional, Juan Fita, Maria Jose, additional, Su, Yu-Li, additional, Lin, Yung-Chang, additional, Su, Wen-Pin, additional, Shen, Ying-Chun, additional, Chang, Yen-Hwa, additional, Huang, Yi-Hsiu, additional, Sriuranpong, Virote, additional, Chansriwong, Phichai, additional, Srimuninnimit, Vichien, additional, Danchaivijitr, Pongwut, additional, Abali, Huseyin, additional, Yavuz, Sinan, additional, Ozyilkan, Ozgur, additional, Sendur, Mehmet Ali Nahit, additional, Ekenel, Meltem, additional, Ozguroglu, Mustafa, additional, Arslan, Cagatay, additional, Ozdogan, Mustafa, additional, Birtle, Alison, additional, Powles, Thomas, additional, Huddart, Robert, additional, de Santis, Maria, additional, Zarkar, Anjali, additional, Evans, Linda, additional, Hussain, Syed, additional, DiSimone, Christopher, additional, Muina, Antonio F, additional, Schlegel, Peter, additional, Jhangiani, Haresh S, additional, Harrison, Michael, additional, Slater, Dennis E, additional, Wright, David, additional, Percent, Ivor J, additional, Lin, Jianqing, additional, Hwang, Clara, additional, Gupta, Sumati, additional, Bajaj, Madhuri, additional, Galamaga, Robert, additional, Eklund, John, additional, Wallace, James, additional, Shtivelband, Mikhail, additional, Suh, Jason Jung-Gon, additional, Burhani, Nafisa, additional, Eadens, Matthew, additional, Gunturu, Krishna, additional, Burgess, Earle, additional, Wong, John, additional, Chaudhry, Arvind, additional, Van Veldhuizen, Peter, additional, Graff, Stephanie, additional, Thomas, Christian A, additional, Schnadig, Ian D, additional, Carneiro, Benedito, additional, Hussain, Maha, additional, Morgans, Alicia, additional, Fitzharris, John T, additional, Oliff, Ira A, additional, Vuky, Jacqueline, additional, Hauke, Ralph, additional, Baron, Ari, additional, Joshi, Monika, additional, Bolemon, Britt H, additional, Jiang, Peter, additional, Mega, Anthony E, additional, Markus, Maurice, additional, Pfanzelter, Nicklas, additional, Lawler, William Eyre, additional, Cobb, Patrick Wayne, additional, Courtright, Jay G, additional, Jain, Sharad, additional, Doshi, Gurjyot, additional, Gunuganti, Vijay K, additional, Sartor, Oliver Alton, additional, Cole, Scott W, additional, Babiker, Hani, additional, Uchio, Edward M, additional, Drakaki, Alexandra, additional, Mannuel, Heather D, additional, Guancial, Elizabeth, additional, Fung, Chunkit, additional, Charles, Anthony, additional, Amato, Robert J, additional, Arriaga, Yull, additional, Bowman, Isaac, additional, Ades, Steven, additional, Dreicer, Robert, additional, Yu, Evan, additional, Quinn, David I, additional, and Fleming, Mark, additional

Published
2021
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24. Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma (ccRCC): Results from 42-month follow-up of KEYNOTE-426.

Author

Rini, Brian I., primary, Plimack, Elizabeth R., additional, Stus, Viktor, additional, Waddell, Tom, additional, Gafanov, Rustem, additional, Pouliot, Frédéric, additional, Nosov, Dmitry, additional, Melichar, Bohuslav, additional, Soulieres, Denis, additional, Borchiellini, Delphine, additional, Vynnychenko, Ihor O., additional, McDermott, Raymond S., additional, Azevedo, Sergio Jobim, additional, Tamada, Satoshi, additional, Kryzhanivska, Anna, additional, Li, Chenxiang, additional, Burgents, Joseph E., additional, Molife, L. Rhoda, additional, Bedke, Jens, additional, and Powles, Thomas, additional

Published
2021
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25. Open-Label, Single-Arm, Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Non–Clear Cell Renal Cell Carcinoma

Author

McDermott, David F., primary, Lee, Jae-Lyun, additional, Ziobro, Marek, additional, Suarez, Cristina, additional, Langiewicz, Przemyslaw, additional, Matveev, Vsevolod Borisovich, additional, Wiechno, Pawel, additional, Gafanov, Rustem Airatovich, additional, Tomczak, Piotr, additional, Pouliot, Frederic, additional, Donskov, Frede, additional, Alekseev, Boris Yakovlevich, additional, Shin, Sang Joon, additional, Bjarnason, Georg A., additional, Castellano, Daniel, additional, Silverman, Rachel Kloss, additional, Perini, Rodolfo F., additional, Schloss, Charles, additional, and Atkins, Michael B., additional

Published
2021
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26. Open-Label, Single-Arm Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Clear Cell Renal Cell Carcinoma

Author

McDermott, David F., primary, Lee, Jae-Lyun, additional, Bjarnason, Georg A., additional, Larkin, James M. G., additional, Gafanov, Rustem A., additional, Kochenderfer, Mark D., additional, Jensen, Niels Viggo, additional, Donskov, Frede, additional, Malik, Jahangeer, additional, Poprach, Alexandr, additional, Tykodi, Scott S., additional, Alonso-Gordoa, Teresa, additional, Cho, Daniel C., additional, Geertsen, Poul F., additional, Climent Duran, Miguel Angel, additional, DiSimone, Christopher, additional, Silverman, Rachel Kloss, additional, Perini, Rodolfo F., additional, Schloss, Charles, additional, and Atkins, Michael B., additional

Published
2021
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27. First-line pembrolizumab (pembro) monotherapy in advanced clear cell renal cell carcinoma (ccRCC): Updated follow-up for KEYNOTE-427 cohort A.

Author

McDermott, David F., primary, Lee, Jae-Lyun, additional, Bjarnason, Georg A., additional, Larkin, James M. G., additional, Gafanov, Rustem, additional, Kochenderfer, Mark D., additional, Jensen, Niels Viggo, additional, Donskov, Frede, additional, Malik, Jahangeer, additional, Poprach, Alexandr, additional, Tykodi, Scott S., additional, Alonso Gordoa, Teresa, additional, Cho, Daniel C., additional, Geertsen, Poul F., additional, Climent Duran, Miguel Angel, additional, Di Simone, Christopher, additional, Du, Xiaoqi, additional, Perini, Rodolfo F., additional, Rodriguez-Lopez, Karla, additional, and Atkins, Michael B., additional

Published
2020
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28. First-line pembrolizumab (pembro) monotherapy in advanced non-clear cell renal cell carcinoma (nccRCC): Updated follow-up for KEYNOTE-427 cohort B.

Author

Lee, Jae-Lyun, primary, Ziobro, Marek, additional, Suarez, Cristina, additional, Langiewitz, Przemyslaw, additional, Matveev, Vsevolod Borisovich, additional, Wiechno, Pawel, additional, Gafanov, Rustem, additional, Tomczak, Piotr, additional, Pouliot, Frédéric, additional, Donskov, Frede, additional, Alekseev, Boris, additional, Shin, Sang Joon, additional, Bjarnason, Georg A., additional, Castellano, Daniel, additional, Du, Xiaoqi, additional, Perini, Rodolfo F., additional, Rodriguez-Lopez, Karla, additional, McDermott, David F., additional, and Atkins, Michael B., additional

Published
2020
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29. Association of gene expression with clinical outcomes in patients with renal cell carcinoma treated with pembrolizumab in KEYNOTE-427.

Author

McDermott, David F., primary, Lee, Jae-Lyun, additional, Donskov, Frede, additional, Tykodi, Scott S., additional, Bjarnason, Georg A., additional, Larkin, James M. G., additional, Gafanov, Rustem, additional, Kochenderfer, Mark D., additional, Malik, Jahangeer, additional, Poprach, Alexandr, additional, Signoretti, Sabina, additional, Cristescu, Razvan, additional, Predoiu, Raluca Andreia, additional, Loboda, Andrey, additional, Zhang, Yiwei, additional, Zhao, Qing, additional, Snyder, Alexandra, additional, Schloss, Charles, additional, Perini, Rodolfo F., additional, and Atkins, Michael B., additional

Published
2020
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30. Pembrolizumab plus axitinib versus sunitinib as first-line therapy for advanced renal cell carcinoma (RCC): Updated analysis of KEYNOTE-426.

Author

Plimack, Elizabeth R., primary, Rini, Brian I., additional, Stus, Viktor, additional, Gafanov, Rustem, additional, Waddell, Tom, additional, Nosov, Dmitry, additional, Pouliot, Frédéric, additional, Soulieres, Denis, additional, Melichar, Bohuslav, additional, Vynnychenko, Ihor, additional, Azevedo, Sergio Jobim, additional, Borchiellini, Delphine, additional, McDermott, Raymond S., additional, Bedke, Jens, additional, Tamada, Satoshi, additional, Yin, Lina, additional, Chen, Mei, additional, Molife, L. Rhoda, additional, Atkins, Michael B., additional, and Powles, Thomas, additional

Published
2020
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32. Evaluation of RNA-sequencing (RNA-seq) signatures with pembrolizumab (pembro) in patients (pts) with renal cell carcinoma (RCC) from KEYNOTE-427 cohort A.

Author

McDermott, David F., primary, Lee, Jae-Lyun, additional, Bjarnason, Georg A., additional, Larkin, James M. G., additional, Gafanov, Rustem Airatovich, additional, Kochenderfer, Mark D., additional, Malik, Jahangeer, additional, Poprach, Alexandr, additional, Tykodi, Scott S., additional, Signoretti, Sabina, additional, Perini, Rodolfo F., additional, Lunceford, Jared, additional, Predoiu, Raluca Andreia, additional, Loboda, Andrey, additional, Zhao, Qing, additional, Snyder, Alexandra, additional, Schloss, Charles, additional, and Atkins, Michael B., additional

Published
2020
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34. KEYNOTE-427 cohort B: First-line pembrolizumab (pembro) monotherapy for advanced non‒clear cell renal cell carcinoma (NCC-RCC).

Author

Lee, Jae-Lyun, primary, Ziobro, Marek, additional, Gafanov, Rustem, additional, Matveev, Vsevolod Borisovich, additional, Suarez, Cristina, additional, Donskov, Frede, additional, Pouliot, Frederic, additional, Alekseev, Boris Yakovlevich, additional, Wiechno, Pawel J., additional, Tomczak, Piotr, additional, Climent, Miguel Ángel, additional, Shin, Sang Joon, additional, Silverman, Rachel Kloss, additional, Perini, Rodolfo F., additional, Schloss, Charles, additional, McDermott, David F., additional, and Atkins, Michael B., additional

Published
2019
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35. Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for metastatic renal cell carcinoma (mRCC): Outcomes in the combined IMDC intermediate/poor risk and sarcomatoid subgroups of the phase 3 KEYNOTE-426 study.

Author

Rini, Brian I., primary, Plimack, Elizabeth R., additional, Stus, Viktor, additional, Gafanov, Rustem, additional, Hawkins, Robert, additional, Nosov, Dmitry, additional, Pouliot, Frederic, additional, Soulieres, Denis, additional, Melichar, Bohuslav, additional, Vynnychenko, Ihor, additional, Azevedo, Sergio Jobim, additional, Borchiellini, Delphine, additional, McDermott, Raymond S., additional, Bedke, Jens, additional, Tamada, Satoshi, additional, Wan, Shuyan, additional, Perini, Rodolfo F., additional, Chen, Mei, additional, Atkins, Michael B., additional, and Powles, Thomas, additional

Published
2019
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36. First-line pembrolizumab (pembro) monotherapy in advanced clear cell renal cell carcinoma (ccRCC): Updated results for KEYNOTE-427 cohort A.

Author

Tykodi, Scott S., primary, Donskov, Frede, additional, Lee, Jae-Lyun, additional, Szczylik, Cezary, additional, Malik, Jahangeer, additional, Alekseev, Boris Yakovlevich, additional, Larkin, James M.G., additional, Matveev, Vsevolod Borisovich, additional, Gafanov, Rustem, additional, Tomczak, Piotr, additional, Geertsen, Poul F., additional, Wiechno, Pawel J., additional, Shin, Sang Joon, additional, Pouliot, Frederic, additional, Alonso-Gordoa, Teresa, additional, Silverman, Rachel Kloss, additional, Perini, Rodolfo F., additional, Schloss, Charles, additional, McDermott, David F., additional, and Atkins, Michael B., additional

Published
2019
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37. Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma

Author

Rini, Brian I., primary, Plimack, Elizabeth R., additional, Stus, Viktor, additional, Gafanov, Rustem, additional, Hawkins, Robert, additional, Nosov, Dmitry, additional, Pouliot, Frédéric, additional, Alekseev, Boris, additional, Soulières, Denis, additional, Melichar, Bohuslav, additional, Vynnychenko, Ihor, additional, Kryzhanivska, Anna, additional, Bondarenko, Igor, additional, Azevedo, Sergio J., additional, Borchiellini, Delphine, additional, Szczylik, Cezary, additional, Markus, Maurice, additional, McDermott, Raymond S., additional, Bedke, Jens, additional, Tartas, Sophie, additional, Chang, Yen-Hwa, additional, Tamada, Satoshi, additional, Shou, Qiong, additional, Perini, Rodolfo F., additional, Chen, Mei, additional, Atkins, Michael B., additional, and Powles, Thomas, additional

Published
2019
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38. First-line pembrolizumab (pembro) monotherapy for advanced non-clear cell renal cell carcinoma (nccRCC): Results from KEYNOTE-427 cohort B.

Author

McDermott, David F., primary, Lee, Jae-Lyun, additional, Ziobro, Marek, additional, Gafanov, Rustem Airatovich, additional, Matveev, Vsevolod Borisovich, additional, Suárez, Cristina, additional, Donskov, Frede, additional, Pouliot, Frederic, additional, Alekseev, Boris Y., additional, Wiechno, Pawel, additional, Tomczak, Piotr, additional, Climent Duran, Miguel Angel, additional, Shin, Sang Joon, additional, Silverman, Rachel Kloss, additional, Perini, Rodolfo F., additional, Schloss, Charles, additional, and Atkins, Michael B., additional

Published
2019
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39. Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for locally advanced or metastatic renal cell carcinoma (mRCC): phase III KEYNOTE-426 study.

Author

Powles, Thomas, primary, Plimack, Elizabeth R., additional, Stus, Viktor, additional, Gafanov, Rustem Airatovich, additional, Hawkins, Robert E., additional, Nosov, Dmitry, additional, Pouliot, Frederic, additional, Alekseev, Boris Yakovlevich, additional, Soulieres, Denis, additional, Melichar, Bohuslav, additional, Vynnychenko, Ihor, additional, Kryzhanivska, Anna, additional, Bondarenko, Igor, additional, Azevedo, Sergio Jobim, additional, Borchiellini, Delphine, additional, Shou, Qiong, additional, Perini, Rodolfo F., additional, Chen, Mei, additional, Atkins, Michael B., additional, and Rini, Brian I., additional

Published
2019
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40. Pembrolizumab monotherapy as first-line therapy in advanced clear cell renal cell carcinoma (accRCC): Results from cohort A of KEYNOTE-427.

Author

McDermott, David F., primary, Lee, Jae-Lyun, additional, Szczylik, Cezary, additional, Donskov, Frede, additional, Malik, Jahangeer, additional, Alekseev, Boris Yakovlevich, additional, Larkin, James M. G., additional, Matveev, Vsevolod Borisovich, additional, Gafanov, Rustem Airatovich, additional, Tomczak, Piotr, additional, Tykodi, Scott S., additional, Geertsen, Poul F., additional, Wiechno, Pawel J., additional, Shin, Sang Joon, additional, Pouliot, Frederic, additional, Alonso Gordoa, Teresa, additional, Li, Wenting, additional, Perini, Rodolfo F., additional, Schloss, Charles, additional, and Atkins, Michael B., additional

Published
2018
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41. Phase 3 KEYNOTE-361 trial: Pembrolizumab (pembro) with or without chemotherapy versus chemotherapy alone in advanced urothelial cancer.

Author

Powles, Thomas, primary, Gschwend, Juergen E., additional, Loriot, Yohann, additional, Bellmunt, Joaquim, additional, Geczi, Lajos, additional, Vulsteke, Christof, additional, Abdelsalam, Mahmoud, additional, Gafanov, Rustem, additional, Bae, Woo Kyun, additional, Revesz, Janos, additional, Yamamoto, Yoshiaki, additional, Anido, Urbano, additional, Su, Wen-Pin, additional, Fleming, Mark T., additional, Markus, Maurice, additional, Feng, Dai, additional, Poehlein, Christian Heinrich, additional, and Alva, Ajjai, additional

Published
2017
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42. Pembrolizumab plus axitinib versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma: 5-year analysis of KEYNOTE-426.

Author

Rini, Brian I., Plimack, Elizabeth R., Stus, Viktor, Gafanov, Rustem, Waddell, Tom, Nosov, Dmitry, Pouliot, Frederic, Alekseev, Boris, Soulieres, Denis, Melichar, Bohuslav, Vynnychenko, Ihor O., Azevedo, Sergio Jobim, Borchiellini, Delphine, McDermott, Raymond S., Bedke, Jens, Tamada, Satoshi, Wu, Sterling, Burgents, Joseph, Molife, L. Rhoda, and Powles, Thomas

Published
2023
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43. Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for advanced clear cell renal cell carcinoma (ccRCC): Analysis of progression after first subsequent therapy in KEYNOTE-426

Author

Powles, Thomas, Plimack, Elizabeth R., Stus, Viktor, Waddell, Tom, Gafanov, Rustem, Pouliot, Frederic, Nosov, Dmitry, Melichar, Bohuslav, Soulieres, Denis, Borchiellini, Delphine, Vynnychenko, Ihor, Mcdermott, Raymond S., Azevedo, Sergio Jobim, Tamada, Satoshi, Anna Kryzhanivska, Li, Chenxiang, Burgents, Joseph E., Molife, L. Rhoda, Rini, Brian I., and Bedke, Jens

Subjects
Cancer Research, Oncology
Abstract

4513 Background: The randomized, open-label, phase 3 KEYNOTE-426 study (NCT02853331) met its primary and key secondary end points of improved OS, PFS, and ORR with pembro + axi versus sunitinib as first-line treatment for patients with advanced ccRCC. Extended follow-up (42.8-mo median follow-up) continued to show the superior efficacy of pembro + axi versus sunitinib in this patient population. We describe the results of PFS2 for all randomly assigned patients and across IMDC risk categories. Methods: Treatment-naive patients with advanced ccRCC, Karnofsky Performance Status Scale score ≥70% and measurable disease per RECIST v1.1 were randomly assigned 1:1 to receive pembro 200 mg IV every 3 weeks for up to 35 doses (̃2 y) + axi 5 mg orally twice daily or sunitinib 50 mg orally once daily on a 4-wk on/2-wk off schedule. The end point of this exploratory analysis was PFS2, defined as time from randomization to progression after first subsequent therapy or any-cause death. The Kaplan-Meier method was used to estimate PFS2 and hazard ratios were estimated using a Cox regression model. Results: Of 861 patients, 432 were assigned to receive pembro + axi; 429, to sunitinib. Median time from randomization to the database cutoff date (January 11, 2021) was 42.8 mo (range, 35.6-50.6). Overall, 47.2% of patients (204/432) in the pembro + axi arm and 65.5% of patients (281/429) in the sunitinib arm received ≥1 line of subsequent anticancer therapy. For patients who received subsequent therapy, anti–PD-1/PD-L1 agents were the first subsequent treatment for 11.3% of patients (23/204) in the pembro + axi arm and 54.8% of patients (154/281) in the sunitinib arm. In the pembro + axi arm, 82.8% of patients (169/204) received a VEGF/VEGFR inhibitor as first subsequent therapy, as did 43.4% (122/281) in the sunitinib arm. PFS2 results are displayed in the Table. Conclusions: In this exploratory analysis, PFS2 was longer for patients randomized to pembro + axi compared to sunitinib. Results were consistent across IMDC risk groups. These data support use of pembro + axi for the first-line treatment of patients with advanced ccRCC. Clinical trial information: NCT02853331. [Table: see text]

44. Outcomes by Retrospective Eligibility for Maintenance Therapy of Patients With Advanced Urothelial Carcinoma: Post Hoc Analysis of the Phase 3 KEYNOTE-361 Trial.

Author

Mamtani R, Matsubara N, Pino AM, Herranz UA, Şendur MAN, Gravis G, Huillard O, Lee HJ, Gafanov R, Joly F, Bedke J, Sella A, Chang YH, Imai K, Moreno BH, Xu JZ, Alva A, and Powles T

Abstract

Introduction: The phase 3 KEYNOTE-361 trial of first-line pembrolizumab with or without chemotherapy versus chemotherapy alone in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) completed enrollment before the approval of postchemotherapy maintenance avelumab for patients without progressive disease. This post hoc analysis evaluated the outcomes of patients who received chemotherapy alone in KEYNOTE-361 by retrospective eligibility for subsequent maintenance therapy., Patients and Methods: Patients in the chemotherapy alone arm were retrospectively categorized as maintenance eligible (received ≥4 cycles of chemotherapy and did not die or experience disease progression within 10 weeks of chemotherapy completion), maintenance ineligible (received <4 cycles of chemotherapy or had progressive disease or died within 0-10 weeks after completion of ≥4 cycles of chemotherapy), and indeterminate eligibility for maintenance therapy (if neither maintenance eligible or ineligible). End points included progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1 by blinded independent central review and overall survival from randomization (start of chemotherapy)., Results: Median follow-up was 31.7 months (range, 22.0-42.3). Among 342 patients who received chemotherapy alone, 172 (50.3%) were maintenance eligible, 108 (31.6%) were maintenance ineligible, and 62 (18.1%) had indeterminate eligibility for maintenance therapy. The median progression-free survival was 9.0 months (95% CI 8.4-10.4) in maintenance-eligible patients, 5.1 months (4.2-6.0) in maintenance-ineligible patients, and 2.3 months (1.9-3.8) in the indeterminate group; median overall survival was 23.3 months (95% CI 19.4-26.1), 10.2 months (9.1-11.6), and 5.5 months (3.7-8.5), respectively., Conclusion: This post hoc analysis suggests that a majority of patients with untreated la/mUC who initiated chemotherapy in a clinical trial may have been considered eligible for maintenance therapy and had favorable survival outcomes compared with those considered maintenance ineligible., Competing Interests: Disclosure R. Mamtani reports research grants or contracts to his institution from Astellas and MSD and consulting fees from Astellas, Bristol Myers Squibb, Merck & Co, Inc, and Seagen outside the submitted work. N. Matsubara reports research grants or contracts to his institution from AbbVie, Amgen, Astellas, AstraZeneca, Bayer, Chugai, Eisai, Eli Lilly, Janssen, MSD, Pfizer, PRA Health Science, Roche, Taiho, Takeda, and Seagen; personal payment or honoraria from Sanofi; and support for attending meetings and/or travel from Pfizer outside the submitted work. A. Montesa Pino reports consulting fees from Advanced Accelerator Applications, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Ipsen, Janssen, Merck & Co, Inc, MSD, Novartis, and Pfizer; support for attending meetings and/or travel from Bayer, Ipsen, Merck & Co, Inc, and Pfizer; and participation on a data safety monitoring board or advisory board of Advanced Accelerator Applications, Ipsen, and Merck & Co, Inc outside the submitted work. U. Anido Herranz reports payments for lectures from Ipsen and Merck & Co, Inc outside the submitted work. M. A. N. Şendur reports consulting fees and payments or honoraria from Astellas, AstraZeneca, Bristol Myers Squibb, Gilead, Janssen, Lilly, MSD, Novartis, Pfizer, Roche, and Takeda. G. Gravis reports research grants or contracts to his institution from Bristol Myers Squibb and Janssen; payments or honoraria to his institution for lectures, presentations, speaker's bureaus, manuscript writing, or educational events from Advanced Accelerator Applications, Alliance Merck-Pfizer, Amgen, Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, Ipsen, Janssen, MSD, Pfizer, and Sanofi; support for attending meetings and/or travel from AstraZeneca, Bayer, Bristol Myers Squibb, Ipsen, Janssen, MSD, and Pfizer; and participation on a data safety monitoring board or advisory board of Advanced Accelerator Applications, Alliance Merck-Pfizer, AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, Ipsen, Janssen, and Pfizer outside the submitted work. O. Huillard reports payments or honoraria to his institution for lectures, presentations, speaker's bureaus, manuscript writing or educational events from Advanced Accelerator Applications, Bristol Myers Squibb, Eisai, Ipsen, Janssen, MSD, Novartis, Pfizer, and Sanofi; and support for attending meetings and/or travel from Advanced Accelerator Applications and Ipsen outside the submitted work. R. Gafanov reports funding for the present manuscript from MSD; research grants or contracts to him and his institution from Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Ipsen, Jannsen, Pfizer, and Roche; payments or honoraria to him and his institution for lectures, presentations, speaker's bureaus, manuscript writing or educational events from Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Ipsen, Jannsen, Pfizer, and Roche; support for attending meetings and/or travel from Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Ipsen, Jannsen, Pfizer, and Roche; and participation on a data safety monitoring board or advisory board of Astellas, AstraZeneca, Bayer, Bristol Myers Squibb, Ipsen, Jannsen, Pfizer, and Roche outside the submitted work. F. Joly reports grants or contracts to her institution for ISS protocol from Ipsen; consulting fees paid to her for membership of scientific board of Esai Co, Ltd., Ipsen, and Pfizer; payment for lectures from Ipsen and Pfizer; and support for congress attendance from Esai Co, Ltd. and Ipsen. J. Bedke reports receiving medical writing support and local principal investigator payments to his institution for the present manuscript from MSD; local principal investigator payments to his institution from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Ipsen, MSD, Nektar, Novartis, Pfizer, Roche, and Seagen; consulting fees from Apogepha, Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Ipsen, Janssen, Merck Serono, MSD, Pfizer, and Roche; payment or honoraria to him and his institution for lectures, presentations, speaker's bureaus, manuscript writing or educational events from Astellas, Bristol Myers Squibb, Ipsen, Merck Serono, MSD, Pfizer, Roche, and Seagen; support for attending meetings and/or travel from Ipsen and Merck & Co, Inc; payments to his institution for participation on a steering committee of Bristol Myers Squibb, MSD, and Seagen and participation on a data safety monitoring board or advisory board of MSD and Pfizer, outside the submitted work. K. Imai, B. Homet Moreno, and J. Z. Xu are employees of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc, Rahway, NJ, USA, and have stock in Merck & Co, Inc, Rahway, NJ, USA. A. Alva reports funding to his institution for the present manuscript from MSD and research grants or contracts to his institution from MSD. T. Powles reports grants or contracts from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Gilead, Ipsen, Johnson & Johnson, Merck Serono, MSD, Novartis, Pfizer, Seattle Genetics, and Roche; consulting fees from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Incyte, Ipsen, Johnson & Johnson, Mashup, Merck Serono, MSD, Novartis, Pfizer, Roche, and Seattle Genetics; and payment or honoraria for lectures, presentations, speaker's bureaus, manuscript writing or educational events from Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Incyte, Ipsen, Johnson & Johnson, Mashup, Merck Serono, MSD, Novartis, Pfizer, Roche, and Seattle Genetics; support for attending meetings and/or travel from Astellas, AstraZeneca, Gilead, Ipsen, MSD, Pfizer, and Roche; participation on a data safety monitoring board or advisory board of Astellas, AstraZeneca, Bristol Myers Squibb, Eisai, Exelixis, Ipsen, Johnson & Johnson, Merck Serono, MSD, Novartis, Pfizer, Roche, and Seattle Genetics; and other financial or nonfinancial interests as principal investigator for AstraZeneca, Eisai, MSD, Novartis, Pfizer, and Roche/Genentech, outside the submitted work. H. J. Lee, A. Sella, and Y.-H. Chang declare no competing interests., (Copyright © 2024. Published by Elsevier Inc.)

Published
2024
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