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Y. Janjigian, J. Bendell, E. Calvo, Joseph Kim, P. Ascierto, P. Sharma, P. Ott, P. Bono, D. Jaeger, T.R. Evans, F. Braud, I. Chau, M. Tschaika, C. Harbison, Chen-Sheng Lin, Dung Le (2016)
CheckMate-032: Phase I/II, open-label study of safety and activity of nivolumab (nivo) alone or with ipilimumab (ipi) in advanced and metastatic (A/M) gastric cancer (GC).Journal of Clinical Oncology, 34
G. Blumenthal, Lijun Zhang, Hui Zhang, D. Kazandjian, S. Khozin, Shenghui Tang, Kirsten Goldberg, R. Sridhara, P. Keegan, R. Pazdur (2017)
Milestone Analyses of Immune Checkpoint Inhibitors, Targeted Therapy, and Conventional Therapy in Metastatic Non–Small Cell Lung Cancer Trials: A Meta-analysisJAMA Oncology, 3
S. Patel, Dae Kim, R. Bassett, S. Cain, E. Washington, W. Hwu, Kevin Kim, N. Papadopoulos, J. Homsi, P. Hwu, A. Bedikian (2017)
A phase II study of ipilimumab plus temozolomide in patients with metastatic melanomaCancer Immunology, Immunotherapy, 66
M. Reck, I. Bondarenko, A. Luft, P. Serwatowski, F. Barlesi, R. Chacko, M. Sebastian, Haolan Lu, J. Cuillerot, T. Lynch (2013)
Ipilimumab in combination with paclitaxel and carboplatin as first-line therapy in extensive-disease-small-cell lung cancer: results from a randomized, double-blind, multicenter phase 2 trial.Annals of oncology : official journal of the European Society for Medical Oncology, 24 1
A. Balar, M. Galsky, J. Rosenberg, T. Powles, D. Petrylak, J. Bellmunt, Y. Loriot, A. Necchi, J. Hoffman-Censits, J. Pérez-Gracia, N. Dawson, M. Heijden, R. Dreicer, S. Srinivas, M. Retz, R. Joseph, A. Drakaki, U. Vaishampayan, S. Sridhar, D. Quinn, I. Durán, D. Shaffer, B. Eigl, P. Grivas, E. Yu, Shi Li, E. Kadel, Z. Boyd, R. Bourgon, P. Hegde, S. Mariathasan, A. Thåström, O. Abidoye, G. Fine, D. Bajorin (2017)
Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trialThe Lancet, 389
R. Herbst, P. Baas, Dong-Wan Kim, E. Felip, J. Pérez-Gracia, Ji-Youn Han, J. Molina, Joo‐Hang Kim, C. Arvis, M. Ahn, M. Majem, M. Fidler, G. Castro, M. Garrido, G. Lubiniecki, Shentu Yue, E. Im, M. Dolled-Filhart, E. Garon (2016)
Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trialThe Lancet, 387
A. Tsao (2012)
Ipilimumab in Combination With Paclitaxel and Carboplatin As First-Line Treatment in Stage IIIB/IV Non–Small-Cell Lung Cancer: Results From a Randomized, Double-Blind, Multicenter Phase II StudyYearbook of Oncology, 2012
T. Beer, E. Kwon, C. Drake, K. Fizazi, C. Logothetis, G. Gravis, V. Ganju, J. Polikoff, F. Saad, Piotr Humanski, J. Piulats, P. Mella, S. Ng, D. Jaeger, F. Parnis, F. Franke, J. Puente, Roman Carvajal, L. Sengeløv, M. McHenry, Arvind Varma, A. Eertwegh, W. Gerritsen (2017)
Randomized, Double-Blind, Phase III Trial of Ipilimumab Versus Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naive Castration-Resistant Prostate Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 35 1
M. Hellmann, M. Kris, C. Rudin (2016)
Medians and Milestones in Describing the Path to Cancer Cures: Telling "Tails".JAMA oncology, 2 2
B. Besse, M. Johnson, P. Jänne, M. Garassino, W. Eberhardt, S. Peters, C. Toh, T. Kurata, Z. Li, M. Kowanetz, S. Mocci, A. Sandler, N. Rizvi (2015)
16LBA Phase II, single-arm trial (BIRCH) of atezolizumab as first-line or subsequent therapy for locally advanced or metastatic PD-L1-selected non-small cell lung cancer (NSCLC)European Journal of Cancer, 51
M. Reck, A. Luft, A. Szczesna, L. Havel, Sang-We Kim, W. Akerley, M. Pietanza, Yi-long Wu, C. Zielinski, Michael Thomas, E. Felip, K. Gold, L. Horn, J. Aerts, K. Nakagawa, P. Lorigan, A. Pieters, Teresa Sanchez, J. Fairchild, D. Spigel (2016)
Phase III Randomized Trial of Ipilimumab Plus Etoposide and Platinum Versus Placebo Plus Etoposide and Platinum in Extensive-Stage Small-Cell Lung Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 34 31
V. Chiou, M. Burotto (2015)
Pseudoprogression and Immune-Related Response in Solid Tumors.Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 33 31
C. Robert, L. Thomas, I. Bondarenko, S. O'Day, J. Weber, C. Garbe, C. Lebbé, J. Baurain, A. Testori, J. Grob, N. Davidson, J. Richards, M. Maio, A. Hauschild, W. Miller, P. Gascón, M. Lotem, K. Harmankaya, R. Ibrahim, S. Francis, Tai-Tsang Chen, R. Humphrey, A. Hoos, J. Wolchok (2011)
Ipilimumab plus dacarbazine for previously untreated metastatic melanoma.The New England journal of medicine, 364 26
H. Kindler, A. Scherpereel, L. Calabrò, J. Aerts, S. Perez, A. Bearz, K. Nackaerts, D. Fennell, D. Kowalski, A. Tsao, P. Taylor, F. Grosso, S. Antonia, A. Nowak, R. Ibrahim, Maria Taboada, M. Puglisi, P. Stockman, M. Maio (2016)
Tremelimumab as second- or third-line treatment of unresectable malignant mesothelioma (MM): Results from the global, double-blind, placebo-controlled DETERMINE study.Journal of Clinical Oncology, 34
A. Ribas, R. Kefford, M. Marshall, C. Punt, J. Haanen, M. Mármol, C. Garbe, H. Gogas, J. Schachter, G. Linette, P. Lorigan, K. Kendra, M. Maio, U. Trefzer, M. Smylie, G. McArthur, B. Dréno, P. Nathan, J. Mackiewicz, J. Kirkwood, J. Gómez-Navarro, B. Huang, D. Pavlov, A. Hauschild (2013)
Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 31 5
F. Hodi, D. Oble, J. Drappatz, E. Velazquez, N. Ramaiya, N. Ramakrishna, A. Day, A. Kruse, S. Rae, A. Hoos, M. Mihm (2008)
CTLA-4 blockade with ipilimumab induces significant clinical benefit in a female with melanoma metastases to the CNSNature Clinical Practice Oncology, 5
Tai-Tsang Chen (2015)
Milestone Survival: A Potential Intermediate Endpoint for Immune Checkpoint Inhibitors.Journal of the National Cancer Institute, 107 9
S. O'Day, R. Ibrahim, V. DePril, M. Maio, V. Chiarion-Sileni, T. Gajewski, H. Pehamberger, A. Hoos, R. Humphrey, J. Wolchock (2008)
Efficacy and safety of ipilimumab induction and maintenance dosing in patients with advanced melanoma who progressed on one or more prior therapiesJournal of Clinical Oncology, 26
J. Radford (2016)
Nivolumab for recurrent squamous-cell carcinoma of the head and neckBDJ, 221
L. Zimmer, T. Eigentler, F. Kiecker, J. Simon, J. Utikal, P. Mohr, C. Berking, E. Kämpgen, E. Dippel, R. Stadler, A. Hauschild, M. Fluck, P. Terheyden, R. Rompel, C. Loquai, Zeinab Assi, C. Garbe, D. Schadendorf (2015)
Open-label, multicenter, single-arm phase II DeCOG-study of ipilimumab in pretreated patients with different subtypes of metastatic melanomaJournal of Translational Medicine, 13
F. Hodi, M. Butler, D. Oble, M. Seiden, M. Seiden, F. Haluska, A. Kruse, Suzanne Macrae, Marybeth Nelson, C. Canning, I. Lowy, A. Korman, D. Lautz, Sara Russell, M. Jaklitsch, N. Ramaiya, Teresa Chen, D. Neuberg, J. Allison, M. Mihm, G. Dranoff (2008)
Immunologic and clinical effects of antibody blockade of cytotoxic T lymphocyte-associated antigen 4 in previously vaccinated cancer patientsProceedings of the National Academy of Sciences, 105
M. Socinski, B. Creelan, L. Horn, M. Reck, L. Paz-Ares, M. Steins, E. Felip, M. Heuvel, T. Ciuleanu, F. Badin, N. Ready, T. Hiltermann, S. Nair, R. Juergens, S. Peters, E. Minenza, W. Geese, P. Bhagavatheeswaran, Allen Chen, D. Carbone (2016)
NSCLC, metastaticCheckMate 026: A phase 3 trial of nivolumab vs investigator's choice (IC) of platinum-based doublet chemotherapy (PT-DC) as first-line therapy for stage iv/recurrent programmed death ligand 1 (PD-L1)−positive NSCLCAnnals of Oncology, 27
C. Robert, G. Long, B. Brady, C. Dutriaux, M. Maio, L. Mortier, J. Hassel, P. Rutkowski, C. McNeil, E. Kalinka‐Warzocha, K. Savage, M. Hernberg, C. Lebbé, J. Charles, C. Mihalcioiu, V. Chiarion-Sileni, C. Mauch, F. Cognetti, A. Arance, H. Schmidt, D. Schadendorf, H. Gogas, L. Lundgren-Eriksson, C. Horak, B. Sharkey, I. Waxman, V. Atkinson, P. Ascierto (2015)
Nivolumab in previously untreated melanoma without BRAF mutation.The New England journal of medicine, 372 4
C. Langer, S. Gadgeel, H. Borghaei, V. Papadimitrakopoulou, A. Patnaik, S. Powell, R. Gentzler, R. Martins, J. Stevenson, S. Jalal, A. Panwalkar, J. Yang, M. Gubens, L. Sequist, M. Awad, J. Fiore, Y. Ge, H. Raftopoulos, L. Gandhi (2016)
Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study.The Lancet. Oncology, 17 11
R. Harrison (2016)
Phase II and phase III failures: 2013–2015Nature Reviews Drug Discovery, 15
John Johnson, Y. Ning, A. Farrell, R. Justice, P. Keegan, R. Pazdur (2011)
Accelerated approval of oncology products: the food and drug administration experience.Journal of the National Cancer Institute, 103 8
F. Hodi, J. Chesney, A. Pavlick, C. Robert, K. Grossmann, D. McDermott, G. Linette, N. Meyer, J. Giguere, S. Agarwala, M. Shaheen, M. Ernstoff, D. Minor, A. Salama, Matthew Taylor, P. Ott, C. Horak, P. Gagnier, Joel Jiang, J. Wolchok, M. Postow (2016)
Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial.The Lancet. Oncology, 17 11
J. Wolchok, B. Neyns, G. Linette, S. Négrier, J. Lutzky, L. Thomas, W. Waterfield, D. Schadendorf, M. Smylie, T. Guthrie, J. Grob, J. Chesney, K. Chin, Kun Chen, A. Hoos, S. O'Day, C. Lebbé (2010)
Ipilimumab monotherapy in patients with pretreated advanced melanoma: a randomised, double-blind, multicentre, phase 2, dose-ranging study.The Lancet. Oncology, 11 2
J. Brahmer, K. Reckamp, P. Baas, L. Crinò, W. Eberhardt, E. Poddubskaya, S. Antonia, A. Płużański, E. Vokes, E. Holgado, D. Waterhouse, N. Ready, J. Gainor, O. Frontera, L. Havel, M. Steins, M. Garassino, J. Aerts, M. Dómine, L. Paz-Ares, M. Reck, C. Baudelet, C. Harbison, B. Lestini, D. Spigel (2015)
Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer.The New England journal of medicine, 373 2
S. Gettinger, N. Rizvi, L. Chow, H. Borghaei, J. Brahmer, N. Ready, D. Gerber, F. Shepherd, S. Antonia, J. Goldman, R. Juergens, S. Laurie, F. Nathan, Yun Shen, C. Harbison, M. Hellmann (2016)
Nivolumab Monotherapy for First-Line Treatment of Advanced Non-Small-Cell Lung Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 34 25
(2016)
Nivolumab monotherapy in recurrent metastatic urothelial carcinoma (CheckMate 032): a multicentre, open-label, two-stage, multi-arm, phase 1/2 trial
Jianrong Zhang, W. Liang, Hengrui Liang, Xiaofei Wang, Jianxing He (2019)
Endpoint surrogacy in oncological randomized controlled trials with immunotherapies: a systematic review of trial-level and arm-level meta-analyses.Annals of translational medicine, 7 11
S. Antonia, J. López-Martín, J. Bendell, P. Ott, Matthew Taylor, J. Eder, D. Jäger, C. Pietanza, D. Le, F. Braud, M. Morse, P. Ascierto, L. Horn, A. Amin, R. Pillai, J. Evans, I. Chau, P. Bono, A. Atmaca, P. Sharma, C. Harbison, Chen-Sheng Lin, O. Christensen, E. Calvo (2016)
Nivolumab alone and nivolumab plus ipilimumab in recurrent small-cell lung cancer (CheckMate 032): a multicentre, open-label, phase 1/2 trial.The Lancet. Oncology, 17 7
Yoon-Koo Kang, T. Satoh, M. Ryu, Y. Chao, Ken Kato, H. Chung, Jen‐Shi Chen, K. Muro, W. Kang, T. Yoshikawa, S. Oh, T. Tamura, Keun-Wook Lee, N. Boku, Li‐Tzong Chen (2017)
Nivolumab (ONO-4538/BMS-936558) as salvage treatment after second or later-line chemotherapy for advanced gastric or gastro-esophageal junction cancer (AGC): A double-blinded, randomized, phase III trial.Journal of Clinical Oncology, 35
J. Wolchok, A. Hoos, S. O'Day, J. Weber, O. Hamid, C. Lebbé, M. Maio, Michael Binder, O. Bohnsack, G. Nichol, R. Humphrey, Stephen Hodi (2009)
Guidelines for the Evaluation of Immune Therapy Activity in Solid Tumors: Immune-Related Response CriteriaClinical Cancer Research, 15
N. Rizvi, J. Mazières, D. Planchard, T. Stinchcombe, G. Dy, S. Antonia, L. Horn, H. Léna, E. Minenza, B. Mennecier, G. Otterson, L. Campos, D. Gandara, B. Levy, S. Nair, G. Zalcman, J. Wolf, P. Souquet, E. Baldini, F. Cappuzzo, C. Chouaid, A. Dowlati, R. Sanborn, A. López-Chávez, C. Grohé, R. Huber, C. Harbison, C. Baudelet, B. Lestini, S. Ramalingam (2015)
Activity and safety of nivolumab, an anti-PD-1 immune checkpoint inhibitor, for patients with advanced, refractory squamous non-small-cell lung cancer (CheckMate 063): a phase 2, single-arm trial.The Lancet. Oncology, 16 3
R. Motzer, B. Escudier, D. McDermott, S. George, H. Hammers, S. Srinivas, S. Tykodi, J. Sosman, G. Procopio, E. Plimack, D. Castellano, T. Choueiri, H. Gurney, F. Donskov, P. Bono, J. Wagstaff, T. Gauler, Takeshi Ueda, Yoshihiko Tomita, F. Schutz, C. Kollmannsberger, J. Larkin, A. Ravaud, J. Simon, Li-an Xu, I. Waxman, P. Sharma (2015)
Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma.The New England journal of medicine, 373 19
E. Plimack, H. Hammers, B. Rini, D. McDermott, B. Redman, T. Kuzel, M. Harrison, U. Vaishampayan, H. Drabkin, S. George, T. Logan, K. Margolin, Li-an Xu, I. Waxman, R. Motzer (2015)
Updated survival results from a randomized, dose-ranging phase II study of nivolumab (NIVO) in metastatic renal cell carcinoma (mRCC).Journal of Clinical Oncology, 33
L. Seymour, J. Bogaerts, A. Perrone, R. Ford, Lawrence Schwartz, L. Schwartz, S. Mandrekar, N. Lin, S. Litière, J. Dancey, A. Chen, F. Hodi, P. Therasse, O. Hoekstra, L. Shankar, J. Wolchok, M. Ballinger, M. Ballinger, M. Ballinger, C. Caramella, E. Vries (2017)
iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics.The Lancet. Oncology, 18 3
A. Giacomo, P. Ascierto, P. Queirolo, L. Pilla, R. Ridolfi, M. Santinami, A. Testori, E. Simeone, M. Guidoboni, A. Maurichi, L. Orgiano, G. Spadola, M. Vecchio, R. Danielli, L. Calabrò, Diego Annesi, Diana Giannarelli, C. Maccalli, E. Fonsatti, Giorgio Parmiani, Michele Maio (2015)
Three-year follow-up of advanced melanoma patients who received ipilimumab plus fotemustine in the Italian Network for Tumor Biotherapy (NIBIT)-M1 phase II study.Annals of oncology : official journal of the European Society for Medical Oncology, 26 4
M. Atkins, R. Kudchadkar, M. Sznol, D. McDermott, M. Lotem, J. Schachter, J. Wolchok, W. Urba, T. Kuzel, L. Schuchter, C. Slingluff, M. Ernstoff, J. Fay, P. Friedlander, T. Gajewski, H. Zarour, R. Rotem‐Yehudar, J. Sosman (2014)
Phase 2, multicenter, safety and efficacy study of pidilizumab in patients with metastatic melanoma.Journal of Clinical Oncology, 32
F. Duffaud, P. Therasse (2000)
[New guidelines to evaluate the response to treatment in solid tumors].Bulletin du cancer, 87 12
Jeffrey Weber, S. D’Angelo, D. Minor, F. Hodi, R. Gutzmer, B. Neyns, C. Hoeller, N. Khushalani, Wilson Miller, C. Lao, G. Linette, L. Thomas, P. Lorigan, K. Grossmann, Jessica Hassel, M. Maio, M. Sznol, P. Ascierto, P. Mohr, B. Chmielowski, A. Bryce, I. Svane, J. Grob, Angela Krackhardt, C. Horak, A. Lambert, Arvin Yang, J. Larkin (2015)
Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial.The Lancet. Oncology, 16 4
F. Hodi, W. Hwu, R. Kefford, J. Weber, A. Daud, O. Hamid, A. Patnaik, A. Ribas, C. Robert, T. Gangadhar, A. Joshua, P. Hersey, R. Dronca, R. Joseph, D. Hille, Dahai Xue, Xiaoyun Li, S. Kang, S. Ebbinghaus, A. Perrone, J. Wolchok (2016)
Evaluation of Immune-Related Response Criteria and RECIST v1.1 in Patients With Advanced Melanoma Treated With Pembrolizumab.Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 34 13
L. Fehrenbacher, A. Spira, M. Ballinger, M. Kowanetz, J. Vansteenkiste, J. Mazières, Keunchil Park, David Smith, A. Artal-Cortes, C. Lewanski, F. Braiteh, D. Waterkamp, P. He, W. Zou, Daniel Chen, J. Yi, A. Sandler, A. Rittmeyer (2016)
Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trialThe Lancet, 387
J. Rosenberg, J. Hoffman-Censits, T. Powles, M. Heijden, A. Balar, A. Necchi, N. Dawson, P. O’Donnell, A. Balmanoukian, Y. Loriot, S. Srinivas, M. Retz, P. Grivas, R. Joseph, M. Galsky, M. Fleming, D. Petrylak, J. Pérez-Gracia, H. Burris, D. Castellano, C. Canil, J. Bellmunt, D. Bajorin, D. Nickles, R. Bourgon, G. Frampton, N. Cui, S. Mariathasan, O. Abidoye, G. Fine, R. Dreicer (2016)
Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trialThe Lancet, 387
L. Fong, A. Hotson, J. Powderly, M. Sznol, R. Heist, T. Choueiri, S. George, B. Hughes, M. Hellmann, D. Shepard, B. Rini, S. Kummar, A. Weise, Matthew Riese, B. Markman, L. Emens, D. Mahadevan, J. Luke, G. Laport, J. Brody, L. Hernandez-Aya, P. Bonomi, J. Goldman, L. Berim, D. Renouf, R. Goodwin, B. Munneke, P. Ho, J. Hsieh, I. McCaffery, L. Kwei, S. Willingham, Richard Miller (2019)
Adenosine A2A Receptor Blockade as an Immunotherapy for Treatment-Refractory Renal Cell Cancer.Cancer discovery
A. Ribas, I. Puzanov, R. Dummer, D. Schadendorf, O. Hamid, C. Robert, F. Hodi, J. Schachter, A. Pavlick, Karl Lewis, L. Cranmer, Christian Blank, S. O'Day, P. Ascierto, April Salama, K. Margolin, C. Loquai, Thomas Eigentler, T. Gangadhar, M. Carlino, S. Agarwala, S. Moschos, J. Sosman, S. Goldinger, R. Shapira-Frommer, R. Gonzalez, J. Kirkwood, J. Wolchok, A. Eggermont, Xiaoyun Li, W. Zhou, Adriane Zernhelt, Joy Lis, S. Ebbinghaus, S. Kang, A. Daud (2015)
Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial.The Lancet. Oncology, 16 8
D. Pardoll (2012)
The blockade of immune checkpoints in cancer immunotherapyNature Reviews Cancer, 12
H. Léna, N. Rizvi, J. Wolf, F. Cappuzzo, G. Zalcman, P. Baas, J. Mazières, B. Farsaci, M. Blackwood-Chirchir, S. Ramalingam (2016)
Nivolumab in patients (pts) with advanced refractory squamous (SQ) non‐small cell lung cancer (NSCLC): 2‐year follow‐up from CheckMate 063 and exploratory cytokine profling analyses: 137OJournal of Thoracic Oncology, 11
M. Reck, D. Rodríguez-Abreu, A. Robinson, R. Hui, T. Csőszi, A. Fülöp, M. Gottfried, N. Peled, A. Tafreshi, S. Cuffe, M. O'Brien, Suman Rao, K. Hotta, M. Leiby, G. Lubiniecki, Shentu Yue, Reshma Rangwala, J. Brahmer (2016)
Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer.The New England journal of medicine, 375 19
A. Rittmeyer, F. Barlesi, D. Waterkamp, Keunchil Park, F. Ciardiello, J. Pawel, S. Gadgeel, T. Hida, D. Kowalski, M. Dols, D. Cortinovis, J. Leach, J. Polikoff, C. Barrios, F. Kabbinavar, O. Frontera, F. Marinis, H. Turna, Jong-Seok Lee, M. Ballinger, M. Kowanetz, P. He, Daniel Chen, A. Sandler, D. Gandara (2017)
Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trialThe Lancet, 389
S. Topalian, F. Hodi, J. Brahmer, S. Gettinger, David Smith, D. McDermott, J. Powderly, J. Sosman, J. Sosman, M. Atkins, M. Atkins, P. Leming, D. Spigel, S. Antonia, A. Drilon, J. Wolchok, R. Carvajal, R. Carvajal, M. McHenry, F. Hosein, C. Harbison, J. Grosso, M. Sznol (2019)
Five-Year Survival and Correlates Among Patients With Advanced Melanoma, Renal Cell Carcinoma, or Non–Small Cell Lung Cancer Treated With NivolumabJAMA Oncology, 5
H. Kaufman, J. Russell, O. Hamid, S. Bhatia, P. Terheyden, S. D’Angelo, K. Shih, C. Lebbé, G. Linette, M. Milella, I. Brownell, K. Lewis, J. Lorch, K. Chin, L. Mahnke, A. Heydebreck, J. Cuillerot, P. Nghiem (2016)
Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial.The Lancet. Oncology, 17 10
J. Kirkwood, P. Lorigan, P. Hersey, A. Hauschild, C. Robert, D. McDermott, M. Marshall, J. Gómez-Navarro, Jane Liang, C. Bulanhagui (2010)
Phase II Trial of Tremelimumab (CP-675,206) in Patients with Advanced Refractory or Relapsed MelanomaClinical Cancer Research, 16
H. Borghaei, L. Paz-Ares, L. Horn, D. Spigel, M. Steins, N. Ready, L. Chow, E. Vokes, E. Felip, E. Holgado, F. Barlesi, M. Kohlhäufl, O. Arrieta, M. Burgio, J. Fayette, H. Léna, E. Poddubskaya, D. Gerber, S. Gettinger, C. Rudin, N. Rizvi, L. Crinò, G. Blumenschein, S. Antonia, C. Dorange, C. Harbison, F. Finckenstein, J. Brahmer (2015)
Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer.The New England journal of medicine, 373 17
G. Oxnard, Katharine Wilcox, M. Gonen, M. Polotsky, B. Hirsch, L. Schwartz (2016)
Response Rate as a Regulatory End Point in Single-Arm Studies of Advanced Solid Tumors.JAMA oncology, 2 6
Key PointsQuestionWhat is the most appropriate primary end point in phase 2 trials of checkpoint inhibitors? FindingsIn this systematic review and meta-analysis of phase 2 and phase 3 trials of checkpoint inhibitors in advanced solid cancers, response rate correlated poorly with overall survival, but 6-month progression-free survival was a better predictor of 12-month overall survival. MeaningSix-month progression-free survival is recommended in place of response rate as an end point in future phase 2 checkpoint-inhibitor trials.
JAMA Oncology – American Medical Association
Published: Apr 22, 2018
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