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2. Single-cell transcriptomic analyses reveal distinct immune cell contributions to epithelial barrier dysfunction in checkpoint inhibitor colitis

Author

Thomas, Molly Fisher, Slowikowski, Kamil, Manakongtreecheep, Kasidet, Sen, Pritha, Samanta, Nandini, Tantivit, Jessica, Nasrallah, Mazen, Zubiri, Leyre, Smith, Neal P., Tirard, Alice, Ramesh, Swetha, Arnold, Benjamin Y., Nieman, Linda T., Chen, Jonathan H., Eisenhaure, Thomas, Pelka, Karin, Song, Yuhui, Xu, Katherine H., Jorgji, Vjola, Pinto, Christopher J., Sharova, Tatyana, Glasser, Rachel, Chan, PuiYee, Sullivan, Ryan J., Khalili, Hamed, Juric, Dejan, Boland, Genevieve M., Dougan, Michael, Hacohen, Nir, Li, Bo, Reynolds, Kerry L., and Villani, Alexandra-Chloé

Published
2024
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4. Cryoablation and post-progression immune checkpoint inhibition in metastatic melanoma: a phase II trial

Author

Mooradian, Meghan J., Fintelmann, Florian J., LaSalle, Thomas J., Simon, Judit, Graur, Alexander, Muzikansky, Alona, Mino-Kenudson, Mari, Shalhout, Sophia, Kaufman, Howard L., Jenkins, Russell W., Lawrence, Donald, Lawless, Aleigha, Sharova, Tatyana, Uppot, Raul N., Fang, Jacy, Blaum, Emily M., Gonye, Anna L. K., Gushterova, Irena, Boland, Genevieve M., Azzoli, Christopher, Hacohen, Nir, Sade-Feldman, Moshe, and Sullivan, Ryan J.

Published
2024
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7. Pembrolizumab in brain metastases of diverse histologies: phase 2 trial results

Author

Brastianos, Priscilla K., Kim, Albert E., Giobbie-Hurder, Anita, Lee, Eudocia Q., Lin, Nancy U., Overmoyer, Beth, Wen, Patrick Y., Nayak, Lakshmi, Cohen, Justine V., Dietrich, Jorg, Eichler, April, Heist, Rebecca S., Krop, Ian, Lawrence, Donald, Ligibel, Jennifer, Tolaney, Sara, Mayer, Erica, Winer, Eric, Bent, Brittany, de Sauvage, Magali A., Ijad, Nazanin, Larson, Juliana M., Marion, Braxton, Nason, Sally, Murthy, Naina, Ratcliff, Sherry, Summers, Elizabeth J., Mahar, Maura, Shih, Helen A., Oh, Kevin, Cahill, Daniel P., Gerstner, Elizabeth R., and Sullivan, Ryan J.

Published
2023
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9. Benefit, recurrence pattern, and toxicity to adjuvant anti-PD-1 monotherapy varies by ethnicity and melanoma subtype: An international multicenter cohort study

Author

Bai, Xue, Lawless, Aleigha R., Czapla, Juliane A., Gerstberger, Stefanie C., Park, Benjamin C., Jung, Seungyeon, Johnson, Rebecca, Yamazaki, Naoya, Ogata, Dai, Umeda, Yoshiyasu, Li, Caili, Guo, Jun, Flaherty, Keith T., Nakamura, Yasuhiro, Namikawa, Kenjiro, Long, Georgina V., Menzies, Alexander M., Johnson, Douglas B., Sullivan, Ryan J., Boland, Genevieve M., and Si, Lu

Published
2024
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12. Perspectives in Immunotherapy: meeting report from Immunotherapy Bridge (Naples, November 30th–December 1st, 2022)

Author

Ascierto, Paolo A., Avallone, Antonio, Bifulco, Carlo, Bracarda, Sergio, Brody, Joshua D., Emens, Leisha A., Ferris, Robert L., Formenti, Silvia C., Hamid, Omid, Johnson, Douglas B., Kirchhoff, Tomas, Klebanoff, Christopher A., Lesinski, Gregory B., Monette, Anne, Neyns, Bart, Odunsi, Kunle, Paulos, Chrystal M., Powell, Jr., Daniel J., Rezvani, Katayoun, Segal, Brahm H., Singh, Nathan, Sullivan, Ryan J., Fox, Bernard A., and Puzanov, Igor

Published
2023
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13. Outcomes of patients with resected stage III/IV acral or mucosal melanoma, treated with adjuvant anti-PD-1 based therapy

Author

Jacques, Sarah K., McKeown, Janet, Grover, Piyush, Johnson, Douglas B., Zaremba, Anne, Dimitriou, Florentia, Weiser, Roi, Farid, Mohamad, Namikawa, Kenjiro, Sullivan, Ryan J., Rutkowski, Piotr, Lebbe, Celeste, Hamid, Omid, Zager, Jonathan S., Michielin, Olivier, Neyns, Bart, Nakamura, Yasuhiro, Robert, Caroline, Mehnert, Janice, Ascierto, Paolo A., Bhave, Prachi, Park, Benjamin, Zimmer, Lisa, Mangana, Joanna, Mooradian, Megan, Placzke, Joanna, Allayous, Clare, Glitza Oliva, Isabella C., Mehmi, Inderjit, Depalo, Danielle, Wicky, Alexandre, Schwarze, Julia K., Roy, Severine, Boatwright, Christina, Vanella, Vito, Long, Georgina V., Menzies, Alexander M., Lo, Serigne N., and Carlino, Matteo S.

Published
2024
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14. Individualised neoantigen therapy mRNA-4157 (V940) plus pembrolizumab versus pembrolizumab monotherapy in resected melanoma (KEYNOTE-942): a randomised, phase 2b study

Author

Weber, Jeffrey S, Carlino, Matteo S, Khattak, Adnan, Meniawy, Tarek, Ansstas, George, Taylor, Matthew H, Kim, Kevin B, McKean, Meredith, Long, Georgina V, Sullivan, Ryan J, Faries, Mark, Tran, Thuy T, Cowey, C Lance, Pecora, Andrew, Shaheen, Montaser, Segar, Jennifer, Medina, Theresa, Atkinson, Victoria, Gibney, Geoffrey T, Luke, Jason J, Thomas, Sajeve, Buchbinder, Elizabeth I, Healy, Jane A, Huang, Mo, Morrissey, Manju, Feldman, Igor, Sehgal, Vasudha, Robert-Tissot, Celine, Hou, Peijie, Zhu, Lili, Brown, Michelle, Aanur, Praveen, Meehan, Robert S, and Zaks, Tal

Published
2024
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16. The “Great Debate” at Immunotherapy Bridge 2020, December 3rd, 2020

Author

Ascierto, Paolo A, Brody, Joshua, Butterfield, Lisa H, Finn, Olivera J, Goldberg, John, Perrone, Francesco, Sullivan, Ryan J, Fox, Bernard A, Hwu, Patrick, and Puzanov, Igor

Subjects
Biomedical and Clinical Sciences, Immunology, Immunization, Vaccine Related, Immunotherapy, Italy, Cancer vaccine, Checkpoint inhibitors, Nivolumab, Pembrolizumab, Overall survival, Progression-free survival, Clinical trials, Medical and Health Sciences, Biomedical and clinical sciences, Health sciences
Abstract

As part of the 2020 Immunotherapy Bridge virtual congress (December 2nd-3rd, Italy), the Great Debate session featured counterpoint views from leading experts on three clinical questions in immunotherapy today. The first of these was whether antitumoral vaccination is still a treatment option. The second topic debated whether anti-programmed death (PD)-1/PD-ligand (L)1 blockade should be the backbone for immunotherapy combination. Finally, the use of innovative study designs and surrogate endpoints was considered from both an academic and industry perspective. For each topic, two experts presented the argument and counter-argument in support of two different points of view. As with previous Bridge congresses, the debates were assigned by meeting Chairs and positions taken by experts during the debates may not have necessarily reflected their respective personal view. The views summarised in this article are based on available evidence but may reflect personal interpretation of these data, clinical experience and subjective opinion of the speaker.

Published
2021

18. The State of Melanoma: Emergent Challenges and Opportunities

Author

Atkins, Michael B, Curiel-Lewandrowski, Clara, Fisher, David E, Swetter, Susan M, Tsao, Hensin, Aguirre-Ghiso, Julio A, Soengas, Maria S, Weeraratna, Ashani T, Flaherty, Keith T, Herlyn, Meenhard, Sosman, Jeffrey A, Tawbi, Hussein A, Pavlick, Anna C, Cassidy, Pamela B, Chandra, Sunandana, Chapman, Paul B, Daud, Adil, Eroglu, Zeynep, Ferris, Laura K, Fox, Bernard A, Gershenwald, Jeffrey E, Gibney, Geoffrey T, Grossman, Douglas, Hanks, Brent A, Hanniford, Douglas, Hernando, Eva, Jeter, Joanne M, Johnson, Douglas B, Khleif, Samir N, Kirkwood, John M, Leachman, Sancy A, Mays, Darren, Nelson, Kelly C, Sondak, Vernon K, Sullivan, Ryan J, Merlino, Glenn, and Foundation, on behalf of the Melanoma Research

Subjects
Prevention, Cancer, Biomedical Research, COVID-19, Humans, Medical Oncology, Melanoma, Practice Guidelines as Topic, SARS-CoV-2, Skin Neoplasms, Melanoma Research Foundation, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

Five years ago, the Melanoma Research Foundation (MRF) conducted an assessment of the challenges and opportunities facing the melanoma research community and patients with melanoma. Since then, remarkable progress has been made on both the basic and clinical research fronts. However, the incidence, recurrence, and death rates for melanoma remain unacceptably high and significant challenges remain. Hence, the MRF Scientific Advisory Council and Breakthrough Consortium, a group that includes clinicians and scientists, reconvened to facilitate intensive discussions on thematic areas essential to melanoma researchers and patients alike, prevention, detection, diagnosis, metastatic dormancy and progression, response and resistance to targeted and immune-based therapy, and the clinical consequences of COVID-19 for patients with melanoma and providers. These extensive discussions helped to crystalize our understanding of the challenges and opportunities facing the broader melanoma community today. In this report, we discuss the progress made since the last MRF assessment, comment on what remains to be overcome, and offer recommendations for the best path forward.

Published
2021

19. Dabrafenib plus trametinib versus anti-PD-1 monotherapy as adjuvant therapy in BRAF V600-mutant stage III melanoma after definitive surgery: a multicenter, retrospective cohort study

Author

Bai, Xue, Shaheen, Ahmed, Grieco, Charlotte, d’Arienzo, Paolo D., Mina, Florentia, Czapla, Juliane A., Lawless, Aleigha R., Bongiovanni, Eleonora, Santaniello, Umberto, Zappi, Helena, Dulak, Dominika, Williamson, Andrew, Lee, Rebecca, Gupta, Avinash, Li, Caili, Si, Lu, Ubaldi, Martina, Yamazaki, Naoya, Ogata, Dai, Johnson, Rebecca, Park, Benjamin C., Jung, Seungyeon, Madonna, Gabriele, Hochherz, Juliane, Umeda, Yoshiyasu, Nakamura, Yasuhiro, Gebhardt, Christoffer, Festino, Lucia, Capone, Mariaelena, Ascierto, Paolo Antonio, Johnson, Douglas B., Lo, Serigne N., Long, Georgina V., Menzies, Alexander M., Namikawa, Kenjiro, Mandala, Mario, Guo, Jun, Lorigan, Paul, Najjar, Yana G., Haydon, Andrew, Quaglino, Pietro, Boland, Genevieve M., Sullivan, Ryan J., Furness, Andrew J.S., Plummer, Ruth, and Flaherty, Keith T.

Published
2023
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20. Long-term outcomes and persistent toxicities following BRAF/MEK inhibitor therapy for advanced melanoma

Author

Goodman, Rachel S., Di Guardo, Lorenza, Maurichi, Andrea, Kirwin, Brendan, Khattak, Adnan, Vanella, Vito, Lee, Joanna, Lawless, Aleigha, Czapla, Juliane, Spagnoletti, Andrea, Ambrosini, Margherita, Livingstone, Elisabeth, Long, Georgina V., Sullivan, Ryan J., Carlino, Matteo S., Atkinson, Victoria, Trojanello, Claudia, Ascierto, Paolo A., Schadendorf, Dirk, Warburton, Lydia, Menzies, Alexander M., Santinami, Mario, and Johnson, Douglas B.

Published
2023
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21. Myocardial T1 and T2 Mapping by Magnetic Resonance in Patients With Immune Checkpoint Inhibitor-Associated Myocarditis.

Author

Thavendiranathan, Paaladinesh, Zhang, Lili, Zafar, Amna, Drobni, Zsofia D, Mahmood, Syed S, Cabral, Marcella, Awadalla, Magid, Nohria, Anju, Zlotoff, Daniel A, Thuny, Franck, Heinzerling, Lucie M, Barac, Ana, Sullivan, Ryan J, Chen, Carol L, Gupta, Dipti, Kirchberger, Michael C, Hartmann, Sarah E, Weinsaft, Jonathan W, Gilman, Hannah K, Rizvi, Muhammad A, Kovacina, Bojan, Michel, Caroline, Sahni, Gagan, González-Mansilla, Ana, Calles, Antonio, Fernández-Avilés, Francisco, Mahmoudi, Michael, Reynolds, Kerry L, Ganatra, Sarju, Gavira, Juan José, González, Nahikari Salterain, García de Yébenes Castro, Manuel, Kwong, Raymond Y, Jerosch-Herold, Michael, Coelho-Filho, Otavio R, Afilalo, Jonathan, Zataraín-Nicolás, Eduardo, Baksi, A John, Wintersperger, Bernd J, Calvillo-Arguelles, Oscar, Ederhy, Stephane, Yang, Eric H, Lyon, Alexander R, Fradley, Michael G, and Neilan, Tomas G

Abstract

Myocarditis is a potentially fatal complication of immune checkpoint inhibitor (ICI) therapy. Data on the utility of cardiovascular magnetic resonance (CMR) T1 and T2 mapping in ICI myocarditis are limited.This study sought to assess the value of CMR T1 and T2 mapping in patients with ICI myocarditis.In this retrospective study from an international registry of patients with ICI myocarditis, clinical and CMR findings (including T1 and T2 maps) were collected. Abnormal T1 and T2 were defined as 2 SD above site (vendor/field strength specific) reference values and a z-score was calculated for each patient. Major adverse cardiovascular events (MACE) were a composite of cardiovascular death, cardiogenic shock, cardiac arrest, and complete heart block.Of 136 patients with ICI myocarditis with a CMR, 86 (63%) had T1 maps and 79 (58%) also had T2 maps. Among the 86 patients (66.3 ± 13.1 years of age), 36 (41.9%) had a left ventricular ejection fraction

Published
2021

24. Major Adverse Cardiovascular Events and the Timing and Dose of Corticosteroids in Immune Checkpoint Inhibitor�Associated Myocarditis

Author

Zhang, Lili, Zlotoff, Daniel A, Awadalla, Magid, Mahmood, Syed S, Nohria, Anju, Hassan, Malek Z.O., Thuny, Franck, Zubiri, Leyre, Chen, Carol L, Sullivan, Ryan J, Alvi, Raza M, Rokicki, Adam, Murphy, Sean P, Jones-O’Connor, Maeve, Heinzerling, Lucie M, Barac, Ana, Forrestal, Brian J, Yang, Eric H, Gupta, Dipti, Kirchberger, Michael C, Shah, Sachin P, Rizvi, Muhammad A, Sahni, Gagan, Mandawat, Anant, Mahmoudi, Michael, Ganatra, Sarju, Ederhy, Stephane, Zatarain-Nicolas, Eduardo, Groarke, John D, Tocchetti, Carlo G, Lyon, Alexander R, Thavendiranathan, Paaladinesh, Cohen, Justine V, Reynolds, Kerry L, Fradley, Michael G, and Neilan, Tomas G

Published
2020

25. Cardiovascular magnetic resonance in immune checkpoint inhibitor-associated myocarditis.

Author

Zhang, Lili, Awadalla, Magid, Mahmood, Syed S, Nohria, Anju, Hassan, Malek Z O, Thuny, Franck, Zlotoff, Daniel A, Murphy, Sean P, Stone, James R, Golden, Doll Lauren Alexandra, Alvi, Raza M, Rokicki, Adam, Jones-O'Connor, Maeve, Cohen, Justine V, Heinzerling, Lucie M, Mulligan, Connor, Armanious, Merna, Barac, Ana, Forrestal, Brian J, Sullivan, Ryan J, Kwong, Raymond Y, Yang, Eric H, Damrongwatanasuk, Rongras, Chen, Carol L, Gupta, Dipti, Kirchberger, Michael C, Moslehi, Javid J, Coelho-Filho, Otavio R, Ganatra, Sarju, Rizvi, Muhammad A, Sahni, Gagan, Tocchetti, Carlo G, Mercurio, Valentina, Mahmoudi, Michael, Lawrence, Donald P, Reynolds, Kerry L, Weinsaft, Jonathan W, Baksi, A John, Ederhy, Stephane, Groarke, John D, Lyon, Alexander R, Fradley, Michael G, Thavendiranathan, Paaladinesh, and Neilan, Tomas G

Abstract

Myocarditis is a potentially fatal complication of immune checkpoint inhibitors (ICI). Sparse data exist on the use of cardiovascular magnetic resonance (CMR) in ICI-associated myocarditis. In this study, the CMR characteristics and the association between CMR features and cardiovascular events among patients with ICI-associated myocarditis are presented.From an international registry of patients with ICI-associated myocarditis, clinical, CMR, and histopathological findings were collected. Major adverse cardiovascular events (MACE) were a composite of cardiovascular death, cardiogenic shock, cardiac arrest, and complete heart block. In 103 patients diagnosed with ICI-associated myocarditis who had a CMR, the mean left ventricular ejection fraction (LVEF) was 50%, and 61% of patients had an LVEF ≥50%. Late gadolinium enhancement (LGE) was present in 48% overall, 55% of the reduced EF, and 43% of the preserved EF cohort. Elevated T2-weighted short tau inversion recovery (STIR) was present in 28% overall, 30% of the reduced EF, and 26% of the preserved EF cohort. The presence of LGE increased from 21.6%, when CMR was performed within 4 days of admission to 72.0% when CMR was performed on Day 4 of admission or later. Fifty-six patients had cardiac pathology. Late gadolinium enhancement was present in 35% of patients with pathological fibrosis and elevated T2-weighted STIR signal was present in 26% with a lymphocytic infiltration. Forty-one patients (40%) had MACE over a follow-up time of 5 months. The presence of LGE, LGE pattern, or elevated T2-weighted STIR were not associated with MACE.These data suggest caution in reliance on LGE or a qualitative T2-STIR-only approach for the exclusion of ICI-associated myocarditis.

Published
2020

26. Efficacy and safety of immune checkpoint inhibitors in young adults with metastatic melanoma

Author

Wong, Selina K., Blum, Steven M., Sun, Xiaopeng, Da Silva, Inês P., Zubiri, Leyre, Ye, Fei, Bai, Kun, Zhang, Kevin, Ugurel, Selma, Zimmer, Lisa, Livingstone, Elisabeth, Schadendorf, Dirk, Serra-Bellver, Patricio, Muñoz-Couselo, Eva, Ortiz, Carolina, Lostes, Julia, Huertas, Roberto M., Arance, Ana, Pickering, Lisa, Long, Georgina V., Carlino, Matteo S., Buchbinder, Elizabeth I., Vázquez-Cortés, Leticia, Jara-Casas, Diego, Márquez-Rodas, Iván, González-Espinoza, Iván R., Balko, Justin M., Menzies, Alexander M., Sullivan, Ryan J., and Johnson, Douglas B.

Published
2023
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29. Safety and efficacy of interleukin-6 blockade for immune-related adverse events: A systematic review and meta-analysis.

Author

Vilbert, Maysa, primary, Koch Hein, Erica C., additional, Madeira, Thiago, additional, Michelon, Isabella, additional, N. Priantti, Jonathan, additional, Lobo, Matheus, additional, Dacoregio, Maria Inez, additional, Castro, Caio, additional, Cavalcante, Ludimila, additional, Wu, Chia-Yun, additional, Rouhani, Sherin Juliet, additional, Merkin, Ross D, additional, Sullivan, Ryan J., additional, and Reynolds, Kerry Lynn, additional

Published
2024
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40. Supplementary Material 1 from Phase I/II Study of Combined BCL-xL and MEK Inhibition with Navitoclax and Trametinib in KRAS or NRAS Mutant Advanced Solid Tumors

Author

Corcoran, Ryan B., primary, Do, Khanh T., primary, Kim, Jeong E., primary, Cleary, James M., primary, Parikh, Aparna R., primary, Yeku, Oladapo O., primary, Xiong, Niya, primary, Weekes, Colin D., primary, Veneris, Jennifer, primary, Ahronian, Leanne G., primary, Mauri, Gianluca, primary, Tian, Jun, primary, Norden, Bryanna L., primary, Michel, Alexa G., primary, Van Seventer, Emily E., primary, Siravegna, Giulia, primary, Camphausen, Kyle, primary, Chi, Gary, primary, Fetter, Isobel J., primary, Brugge, Joan S., primary, Chen, Helen, primary, Takebe, Naoko, primary, Penson, Richard T., primary, Juric, Dejan, primary, Flaherty, Keith T., primary, Sullivan, Ryan J., primary, Clark, Jeffrey W., primary, Heist, Rebecca S., primary, Matulonis, Ursula A., primary, Liu, Joyce F., primary, and Shapiro, Geoffrey I., primary

Published
2024
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41. Dabrafenib plus trametinib versus anti-PD-1 monotherapy as adjuvant therapy in BRAF V600-mutant stage III melanoma after definitive surgery: a multicenter, retrospective cohort study

Author

Bai, Xue, primary, Shaheen, Ahmed, additional, Grieco, Charlotte, additional, d’Arienzo, Paolo D., additional, Mina, Florentia, additional, Czapla, Juliane A., additional, Lawless, Aleigha R., additional, Bongiovanni, Eleonora, additional, Santaniello, Umberto, additional, Zappi, Helena, additional, Dulak, Dominika, additional, Williamson, Andrew, additional, Lee, Rebecca, additional, Gupta, Avinash, additional, Li, Caili, additional, Si, Lu, additional, Ubaldi, Martina, additional, Yamazaki, Naoya, additional, Ogata, Dai, additional, Johnson, Rebecca, additional, Park, Benjamin C., additional, Jung, Seungyeon, additional, Madonna, Gabriele, additional, Hochherz, Juliane, additional, Umeda, Yoshiyasu, additional, Nakamura, Yasuhiro, additional, Gebhardt, Christoffer, additional, Festino, Lucia, additional, Capone, Mariaelena, additional, Ascierto, Paolo Antonio, additional, Johnson, Douglas B., additional, Lo, Serigne N., additional, Long, Georgina V., additional, Menzies, Alexander M., additional, Namikawa, Kenjiro, additional, Mandala, Mario, additional, Guo, Jun, additional, Lorigan, Paul, additional, Najjar, Yana G., additional, Haydon, Andrew, additional, Quaglino, Pietro, additional, Boland, Genevieve M., additional, Sullivan, Ryan J., additional, Furness, Andrew J.S., additional, Plummer, Ruth, additional, and Flaherty, Keith T., additional

Published
2024
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43. Defining D-irAEs: consensus-based disease definitions for the diagnosis of dermatologic adverse events from immune checkpoint inhibitor therapy

Author

Chen, Steven T, primary, Semenov, Yevgeniy R, additional, Alloo, Allireza, additional, Bach, Daniel Q, additional, Betof Warner, Allison, additional, Bougrine, Amina, additional, Burton, Leeann, additional, Cappelli, Laura C, additional, Castells, Mariana, additional, Cohen, Justine, additional, Dewan, Anna K, additional, Fadden, Riley, additional, Guggina, Lauren, additional, Hegde, Aparna, additional, Huang, Victor, additional, Johnson, Douglas B, additional, Kaffenberger, Benjamin, additional, Kroshinsky, Daniela, additional, Kwatra, Shawn, additional, Kwong, Bernice, additional, Lacouture, Mario E, additional, Larocca, Cecilia, additional, Leventhal, Jonathan, additional, Markova, Alina, additional, McDunn, Jon, additional, Mooradian, Meghan J, additional, Naidoo, Jarushka, additional, Choi, Jennifer, additional, Nambudiri, Vinod, additional, Nelson, Caroline A, additional, Patel, Anisha B, additional, Pimkina, Julia, additional, Rine, Johnathan, additional, Rubin, Krista M, additional, Sauder, Maxwell, additional, Shaigany, Sheila, additional, Shariff, Afreen, additional, Sullivan, Ryan J, additional, Zubiri, Leyre, additional, Reynolds, Kerry L, additional, and LeBoeuf, Nicole R, additional

Published
2024
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44. Pre-Existing Autoimmune Disease Increases the Risk of Cardiovascular and Noncardiovascular Events After Immunotherapy

Author

Lee, Charlotte, Drobni, Zsofia D., Zafar, Amna, Gongora, Carlos A., Zlotoff, Daniel A., Alvi, Raza M., Taron, Jana, Rambarat, Paula K., Schoenfeld, Sara, Mosarla, Ramya C., Raghu, Vineet K., Hartmann, Sarah E., Gilman, Hannah K., Murphy, Sean P., Sullivan, Ryan J., Faje, Alexander, Hoffmann, Udo, Zhang, Lili, Mayrhofer, Thomas, Reynolds, Kerry L., and Neilan, Tomas G.

Published
2022
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45. STAG2 regulates interferon signaling in melanoma via enhancer loop reprogramming

Author

Chu, Zhaowei, Gu, Lei, Hu, Yeguang, Zhang, Xiaoyang, Li, Man, Chen, Jiajia, Teng, Da, Huang, Man, Shen, Che-Hung, Cai, Li, Yoshida, Toshimi, Qi, Yifeng, Niu, Zhixin, Feng, Austin, Geng, Songmei, Frederick, Dennie T., Specht, Emma, Piris, Adriano, Sullivan, Ryan J., Flaherty, Keith T., Boland, Genevieve M., Georgopoulos, Katia, Liu, David, Shi, Yang, and Zheng, Bin

Published
2022
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46. Development of MK-8353, an orally administered ERK1/2 inhibitor, in patients with advanced solid tumors

Author

Moschos, Stergios J, Sullivan, Ryan J, Hwu, Wen-Jen, Ramanathan, Ramesh K, Adjei, Alex A, Fong, Peter C, Shapira-Frommer, Ronnie, Tawbi, Hussein A, Rubino, Joseph, Rush, Thomas S, Zhang, Da, Miselis, Nathan R, Samatar, Ahmed A, Chun, Patrick, Rubin, Eric H, Schiller, James, Long, Brian J, Dayananth, Priya, Carr, Donna, Kirschmeier, Paul, Bishop, W Robert, Deng, Yongqi, Cooper, Alan, Shipps, Gerald W, Moreno, Blanca Homet, Robert, Lidia, Ribas, Antoni, and Flaherty, Keith T

Subjects
Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Cancer, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Administration, Oral, Adult, Animals, Biological Availability, Cell Line, Tumor, Diarrhea, Dogs, Dose-Response Relationship, Drug, Drug Eruptions, Drug Evaluation, Preclinical, Fatigue, Female, Humans, Indazoles, MAP Kinase Signaling System, Male, Maximum Tolerated Dose, Mice, Middle Aged, Mitogen-Activated Protein Kinase 1, Mitogen-Activated Protein Kinase 3, Nausea, Neoplasm Staging, Neoplasms, Protein Kinase Inhibitors, Pyridines, Pyrrolidines, Rats, Triazoles, Xenograft Model Antitumor Assays, Young Adult, Clinical Trials, Melanoma, Oncology, Signal transduction, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundConstitutive activation of ERK1/2 occurs in various cancers, and its reactivation is a well-described resistance mechanism to MAPK inhibitors. ERK inhibitors may overcome the limitations of MAPK inhibitor blockade. The dual mechanism inhibitor SCH772984 has shown promising preclinical activity across various BRAFV600/RAS-mutant cancer cell lines and human cancer xenografts.MethodsWe have developed an orally bioavailable ERK inhibitor, MK-8353; conducted preclinical studies to demonstrate activity, pharmacodynamic endpoints, dosing, and schedule; completed a study in healthy volunteers (P07652); and subsequently performed a phase I clinical trial in patients with advanced solid tumors (MK-8353-001). In the P07652 study, MK-8353 was administered as a single dose in 10- to 400-mg dose cohorts, whereas in the MK-8353-001 study, MK-8353 was administered in 100- to 800-mg dose cohorts orally twice daily. Safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity were analyzed.ResultsMK-8353 exhibited comparable potency with SCH772984 across various preclinical cancer models. Forty-eight patients were enrolled in the P07652 study, and twenty-six patients were enrolled in the MK-8353-001 study. Adverse events included diarrhea (44%), fatigue (40%), nausea (32%), and rash (28%). Dose-limiting toxicity was observed in the 400-mg and 800-mg dose cohorts. Sufficient exposure to MK-8353 was noted that correlated with biological activity in preclinical data. Three of fifteen patients evaluable for treatment response in the MK-8353-001 study had partial response, all with BRAFV600-mutant melanomas.ConclusionMK-8353 was well tolerated up to 400 mg twice daily and exhibited antitumor activity in patients with BRAFV600-mutant melanoma. However, antitumor activity was not particularly correlated with pharmacodynamic parameters.Trial registrationClinicalTrials.gov NCT01358331.FundingMerck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., and NIH (P01 CA168585 and R35 CA197633).

Published
2018

47. Tumor cell-based liquid biopsy using high-throughput microfluidic enrichment of entire leukapheresis product

Author

Mishra, Avanish, primary, Huang, Shih-Bo, additional, Dubash, Taronish, additional, Burr, Risa, additional, Edd, Jon F., additional, Wittner, Ben S., additional, Cunneely, Quinn E., additional, Putaturo, Victor R., additional, Deshpande, Akansha, additional, Antmen, Ezgi, additional, Gopinathan, Kaustav A., additional, Otani, Keisuke, additional, Miyazawa, Yoshiyuki, additional, Kwak, Ji Eun, additional, Guay, Sara Y., additional, Kelly, Justin, additional, Walsh, John, additional, Nieman, Linda, additional, Galler, Isabella, additional, Chan, PuiYee, additional, Lawrence, Michael S., additional, Sullivan, Ryan J., additional, Bardia, Aditya, additional, Micalizzi, Douglas S., additional, Sequist, Lecia V., additional, Lee, Richard J., additional, Franses, Joseph W., additional, Ting, David T., additional, Brunker, Patricia A. R., additional, Maheswaran, Shyamala, additional, Miyamoto, David T., additional, Haber, Daniel A., additional, and Toner, Mehmet, additional

Published
2024
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48. Phase I/II Study of Combined BCL-xL and MEK Inhibition with Navitoclax and Trametinib in KRAS or NRAS Mutant Advanced Solid Tumors

Author

Corcoran, Ryan B., primary, Do, Khanh T., additional, Kim, Jeong E., additional, Cleary, James M., additional, Parikh, Aparna R., additional, Yeku, Oladapo O., additional, Xiong, Niya, additional, Weekes, Colin D., additional, Veneris, Jennifer, additional, Ahronian, Leanne G., additional, Mauri, Gianluca, additional, Tian, Jun, additional, Norden, Bryanna L., additional, Michel, Alexa G., additional, Van Seventer, Emily E., additional, Siravegna, Giulia, additional, Camphausen, Kyle, additional, Chi, Gary, additional, Fetter, Isobel J., additional, Brugge, Joan S., additional, Chen, Helen, additional, Takebe, Naoko, additional, Penson, Richard T., additional, Juric, Dejan, additional, Flaherty, Keith T., additional, Sullivan, Ryan J., additional, Clark, Jeffrey W., additional, Heist, Rebecca S., additional, Matulonis, Ursula A., additional, Liu, Joyce F., additional, and Shapiro, Geoffrey I., additional

Published
2024
Full Text
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49. Predicting Recurrence-Free and Overall Survival for Patients With Stage II Melanoma: The MIA Calculator

Author

Varey, Alexander H.R., primary, Li, Isabel, additional, El Sharouni, Mary-Ann, additional, Simon, Julie, additional, Dedeilia, Aikaterini, additional, Ch'ng, Sydney, additional, Saw, Robyn P.M., additional, Spillane, Andrew J., additional, Shannon, Kerwin F., additional, Pennington, Thomas E., additional, Rtshiladze, Michael, additional, Stretch, Jonathan R., additional, Nieweg, Omgo E., additional, van Akkooi, Alexander, additional, Sullivan, Ryan J., additional, Boland, Genevieve M., additional, Gershenwald, Jeffrey E., additional, van Diest, Paul J., additional, Scolyer, Richard A., additional, Long, Georgina V., additional, Thompson, John F., additional, and Lo, Serigne N., additional

Published
2024
Full Text
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