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1. 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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2. 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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3. 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

UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, Powles, Thomas, Csőszi, Tibor, Özgüroğlu, Mustafa, Matsubara, Nobuaki, Géczi, Lajos, Cheng, Susanna Y-S, Fradet, Yves, Oudard, Stephane, Vulsteke, Christof, Morales Barrera, Rafael, Fléchon, Aude, Gunduz, Seyda, Loriot, Yohann, Rodriguez-Vida, Alejo, Mamtani, Ronac, Yu, Evan Y, Nam, Kijoeng, Imai, Kentaro, Homet Moreno, Blanca, Alva, Ajjai, Machiels, Jean-Pascal, UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - (SLuc) Centre du cancer, UCL - (SLuc) Unité d'oncologie médicale, Powles, Thomas, Csőszi, Tibor, Özgüroğlu, Mustafa, Matsubara, Nobuaki, Géczi, Lajos, Cheng, Susanna Y-S, Fradet, Yves, Oudard, Stephane, Vulsteke, Christof, Morales Barrera, Rafael, Fléchon, Aude, Gunduz, Seyda, Loriot, Yohann, Rodriguez-Vida, Alejo, Mamtani, Ronac, Yu, Evan Y, Nam, Kijoeng, Imai, Kentaro, Homet Moreno, Blanca, Alva, Ajjai, and Machiels, Jean-Pascal

Abstract

PD-1 and PD-L1 inhibitors are active in metastatic urothelial carcinoma, but positive randomised data supporting their use as a first-line treatment are lacking. In this study we assessed outcomes with first-line pembrolizumab alone or combined with chemotherapy versus chemotherapy for patients with previously untreated advanced urothelial carcinoma. KEYNOTE-361 is a randomised, open-label, phase 3 trial of patients aged at least 18 years, with untreated, locally advanced, unresectable, or metastatic urothelial carcinoma, with an Eastern Cooperative Oncology Group performance status of up to 2. Eligible patients were enrolled from 201 medical centres in 21 countries and randomly allocated (1:1:1) via an interactive voice-web response system to intravenous pembrolizumab 200 mg every 3 weeks for a maximum of 35 cycles plus intravenous chemotherapy (gemcitabine [1000 mg/m] on days 1 and 8 and investigator's choice of cisplatin [70 mg/m] or carboplatin [area under the curve 5] on day 1 of every 3-week cycle) for a maximum of six cycles, pembrolizumab alone, or chemotherapy alone, stratified by choice of platinum therapy and PD-L1 combined positive score (CPS). Neither patients nor investigators were masked to the treatment assignment or CPS. At protocol-specified final analysis, sequential hypothesis testing began with superiority of pembrolizumab plus chemotherapy versus chemotherapy alone in the total population (all patients randomly allocated to a treatment) for the dual primary endpoints of progression-free survival (p value boundary 0·0019), assessed by masked, independent central review, and overall survival (p value boundary 0·0142), followed by non-inferiority and superiority of overall survival for pembrolizumab versus chemotherapy in the patient population with CPS of at least 10 and in the total population (also a primary endpoint). Safety was assessed in the as-treated population (all patients who received at least one dose of study treatment). This study i

Published
2021

4. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer

Author

Gandhi, Leena, Rodríguez-Abreu, Delvys, Gadgeel, Shirish, Esteban, Emilio, Felip, Enriqueta, De Angelis, Flávia, Domine, Manuel, Clingan, Philip, Hochmair, Maximilian J, Powell, Steven F, Cheng, Susanna Y-S, Bischoff, Helge G, Peled, Nir, Grossi, Francesco, Jennens, Ross R, Reck, Martin, Hui, Rina, Garon, Edward B, Boyer, Michael, Rubio-Viqueira, Belén, Novello, Silvia, Kurata, Takayasu, Gray, Jhanelle E, Vida, John, Wei, Ziwen, Yang, Jing, Raftopoulos, Harry, Pietanza, M Catherine, Garassino, Marina C, KEYNOTE-189 Investigators, Ocak, Sebahat, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - SSS/IREC/PNEU - Pôle de Pneumologie, ORL et Dermatologie, UCL - (MGD) Service d'oncologie médicale, Department of Medicine, Clinicum, and HUS Heart and Lung Center

Subjects
0301 basic medicine, Oncology, Male, Durvalumab, Lung Neoplasms, medicine.medical_treatment, ALK mutations, Pembrolizumab, Kaplan-Meier Estimate, THERAPY, 0302 clinical medicine, Antineoplastic Agents, Immunological, Maintenance therapy, Carcinoma, Non-Small-Cell Lung, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Non-Small-Cell Lung, pemetrexed, Humanized, DOCETAXEL, Aged, 80 and over, Nonsquamous NSCLC, EGFR, pembrolizumab, General Medicine, RANDOMIZED CONTROLLED-TRIAL, Middle Aged, OPEN-LABEL, 3. Good health, Editorial Commentary, Immunological, Pemetrexed, Docetaxel, 030220 oncology & carcinogenesis, INDUCTION TREATMENT, Female, Nivolumab, medicine.drug, Adult, medicine.medical_specialty, Aged, Antibodies, Monoclonal, Humanized, Disease-Free Survival, Double-Blind Method, Follow-Up Studies, Humans, 3122 Cancers, Antineoplastic Agents, Antibodies, Healthcare improvement science Radboud Institute for Health Sciences [Radboudumc 18], 03 medical and health sciences, CISPLATIN, Internal medicine, medicine, Lung cancer, Chemotherapy, business.industry, Carcinoma, NIVOLUMAB, PEMETREXED PLUS, medicine.disease, PHASE-III, 030104 developmental biology, business, 1ST-LINE
Abstract

Contains fulltext : 193627.pdf (Publisher’s version ) (Open Access) BACKGROUND: First-line therapy for advanced non-small-cell lung cancer (NSCLC) that lacks targetable mutations is platinum-based chemotherapy. Among patients with a tumor proportion score for programmed death ligand 1 (PD-L1) of 50% or greater, pembrolizumab has replaced cytotoxic chemotherapy as the first-line treatment of choice. The addition of pembrolizumab to chemotherapy resulted in significantly higher rates of response and longer progression-free survival than chemotherapy alone in a phase 2 trial. METHODS: In this double-blind, phase 3 trial, we randomly assigned (in a 2:1 ratio) 616 patients with metastatic nonsquamous NSCLC without sensitizing EGFR or ALK mutations who had received no previous treatment for metastatic disease to receive pemetrexed and a platinum-based drug plus either 200 mg of pembrolizumab or placebo every 3 weeks for 4 cycles, followed by pembrolizumab or placebo for up to a total of 35 cycles plus pemetrexed maintenance therapy. Crossover to pembrolizumab monotherapy was permitted among the patients in the placebo-combination group who had verified disease progression. The primary end points were overall survival and progression-free survival, as assessed by blinded, independent central radiologic review. RESULTS: After a median follow-up of 10.5 months, the estimated rate of overall survival at 12 months was 69.2% (95% confidence interval [CI], 64.1 to 73.8) in the pembrolizumab-combination group versus 49.4% (95% CI, 42.1 to 56.2) in the placebo-combination group (hazard ratio for death, 0.49; 95% CI, 0.38 to 0.64; P

Published
2018

5. Abstract CT043: Outcomes among patients (pts) with metastatic nonsquamous NSCLC with liver metastases or brain metastases treated with pembrolizumab (pembro) plus pemetrexed-platinum: Results from the KEYNOTE-189 study

Author

Garassino, Marina C., primary, Gadgeel, Shirish, additional, Esteban, Emilio, additional, Felip, Enriqueta, additional, Speranza, Giovanna, additional, Angelis, Flávia De, additional, Domine, Manuel, additional, Clingan, Philip, additional, Hochmair, Maximilian J., additional, Powell, Steven F., additional, Cheng, Susanna Y.-S., additional, Bischoff, Helge G., additional, Peled, Nir, additional, Grossi, Francesco, additional, Jennens, Ross R., additional, Reck, Martin, additional, Hui, Rina, additional, Garon, Edward B., additional, Boyer, Michael, additional, Rubio-Viqueira, Belén, additional, Novello, Silvia, additional, Kurata, Takayasu, additional, Gray, Jhanelle E., additional, Cardellino, Anna, additional, Yang, Jing, additional, Pietanza, M. Catherine, additional, and Rodríguez-Abreu, Delvys, additional

Published
2019
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6. Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer.

Author

Gandhi L, Rodríguez-Abreu D, Gadgeel S, Esteban E, Felip E, De Angelis F, Domine M, Clingan P, Hochmair MJ, Powell SF, Cheng SY, Bischoff HG, Peled N, Grossi F, Jennens RR, Reck M, Hui R, Garon EB, Boyer M, Rubio-Viqueira B, Novello S, Kurata T, Gray JE, Vida J, Wei Z, Yang J, Raftopoulos H, Pietanza MC, and Garassino MC

Subjects
Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized adverse effects, Antineoplastic Agents, Immunological adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carcinoma, Non-Small-Cell Lung genetics, Carcinoma, Non-Small-Cell Lung mortality, Carcinoma, Non-Small-Cell Lung secondary, Disease-Free Survival, Double-Blind Method, Female, Follow-Up Studies, Humans, Kaplan-Meier Estimate, Lung Neoplasms genetics, Lung Neoplasms mortality, Lung Neoplasms pathology, Male, Middle Aged, Antibodies, Monoclonal, Humanized therapeutic use, Antineoplastic Agents, Immunological therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Non-Small-Cell Lung drug therapy, Lung Neoplasms drug therapy
Abstract

Background: First-line therapy for advanced non-small-cell lung cancer (NSCLC) that lacks targetable mutations is platinum-based chemotherapy. Among patients with a tumor proportion score for programmed death ligand 1 (PD-L1) of 50% or greater, pembrolizumab has replaced cytotoxic chemotherapy as the first-line treatment of choice. The addition of pembrolizumab to chemotherapy resulted in significantly higher rates of response and longer progression-free survival than chemotherapy alone in a phase 2 trial., Methods: In this double-blind, phase 3 trial, we randomly assigned (in a 2:1 ratio) 616 patients with metastatic nonsquamous NSCLC without sensitizing EGFR or ALK mutations who had received no previous treatment for metastatic disease to receive pemetrexed and a platinum-based drug plus either 200 mg of pembrolizumab or placebo every 3 weeks for 4 cycles, followed by pembrolizumab or placebo for up to a total of 35 cycles plus pemetrexed maintenance therapy. Crossover to pembrolizumab monotherapy was permitted among the patients in the placebo-combination group who had verified disease progression. The primary end points were overall survival and progression-free survival, as assessed by blinded, independent central radiologic review., Results: After a median follow-up of 10.5 months, the estimated rate of overall survival at 12 months was 69.2% (95% confidence interval [CI], 64.1 to 73.8) in the pembrolizumab-combination group versus 49.4% (95% CI, 42.1 to 56.2) in the placebo-combination group (hazard ratio for death, 0.49; 95% CI, 0.38 to 0.64; P<0.001). Improvement in overall survival was seen across all PD-L1 categories that were evaluated. Median progression-free survival was 8.8 months (95% CI, 7.6 to 9.2) in the pembrolizumab-combination group and 4.9 months (95% CI, 4.7 to 5.5) in the placebo-combination group (hazard ratio for disease progression or death, 0.52; 95% CI, 0.43 to 0.64; P<0.001). Adverse events of grade 3 or higher occurred in 67.2% of the patients in the pembrolizumab-combination group and in 65.8% of those in the placebo-combination group., Conclusions: In patients with previously untreated metastatic nonsquamous NSCLC without EGFR or ALK mutations, the addition of pembrolizumab to standard chemotherapy of pemetrexed and a platinum-based drug resulted in significantly longer overall survival and progression-free survival than chemotherapy alone. (Funded by Merck; KEYNOTE-189 ClinicalTrials.gov number, NCT02578680 .).

Published
2018
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