Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma

Among 886 patients with advanced renal-cell cancer, median progression-free survival was 13.8 months among those assigned to avelumab plus axitinib and 7.2 months among those assigned to sunitinib. Toxic effects of grade 3 or higher were similar in the two groups.

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Bibliographic Details
Published in	The New England journal of medicine Vol. 380; no. 12; pp. 1103 - 1115
Main Authors	Motzer, Robert J, Penkov, Konstantin, Haanen, John, Rini, Brian, Albiges, Laurence, Campbell, Matthew T, Venugopal, Balaji, Kollmannsberger, Christian, Negrier, Sylvie, Uemura, Motohide, Lee, Jae L, Vasiliev, Aleksandr, Miller, Wilson H, Gurney, Howard, Schmidinger, Manuela, Larkin, James, Atkins, Michael B, Bedke, Jens, Alekseev, Boris, Wang, Jing, Mariani, Mariangela, Robbins, Paul B, Chudnovsky, Aleksander, Fowst, Camilla, Hariharan, Subramanian, Huang, Bo, di Pietro, Alessandra, Choueiri, Toni K
Format	Journal Article
Language	English
Published	United States Massachusetts Medical Society 21.03.2019
Subjects	Administration, Intravenous Adult Aged Aged, 80 and over Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal, Humanized Antineoplastic Agents - therapeutic use Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Apoptosis Axitinib - administration & dosage Axitinib - adverse effects Body weight Cancer therapies Carcinoma, Renal Cell - drug therapy Carcinoma, Renal Cell - mortality Drug dosages Evidence-based medicine Female Humans Immunotherapy Inhibitor drugs Kidney cancer Kidney Neoplasms - drug therapy Kidney Neoplasms - mortality Kinases Male Middle Aged Monoclonal antibodies Oncology PD-L1 protein Programmed Cell Death 1 Receptor - antagonists & inhibitors Progression-Free Survival Renal cell carcinoma Single-Blind Method Sunitinib - adverse effects Sunitinib - therapeutic use Survival Rate Targeted cancer therapy Tumors Vascular endothelial growth factor Germany
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Abstract	Among 886 patients with advanced renal-cell cancer, median progression-free survival was 13.8 months among those assigned to avelumab plus axitinib and 7.2 months among those assigned to sunitinib. Toxic effects of grade 3 or higher were similar in the two groups.
AbstractList	Among 886 patients with advanced renal-cell cancer, median progression-free survival was 13.8 months among those assigned to avelumab plus axitinib and 7.2 months among those assigned to sunitinib. Toxic effects of grade 3 or higher were similar in the two groups. In a single-group, phase 1b trial, avelumab plus axitinib resulted in objective responses in patients with advanced renal-cell carcinoma. This phase 3 trial involving previously untreated patients with advanced renal-cell carcinoma compared avelumab plus axitinib with the standard-of-care sunitinib. We randomly assigned patients in a 1:1 ratio to receive avelumab (10 mg per kilogram of body weight) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary end points were progression-free survival and overall survival among patients with programmed death ligand 1 (PD-L1)-positive tumors. A key secondary end point was progression-free survival in the overall population; other end points included objective response and safety. A total of 886 patients were assigned to receive avelumab plus axitinib (442 patients) or sunitinib (444 patients). Among the 560 patients with PD-L1-positive tumors (63.2%), the median progression-free survival was 13.8 months with avelumab plus axitinib, as compared with 7.2 months with sunitinib (hazard ratio for disease progression or death, 0.61; 95% confidence interval [CI], 0.47 to 0.79; P<0.001); in the overall population, the median progression-free survival was 13.8 months, as compared with 8.4 months (hazard ratio, 0.69; 95% CI, 0.56 to 0.84; P<0.001). Among the patients with PD-L1-positive tumors, the objective response rate was 55.2% with avelumab plus axitinib and 25.5% with sunitinib; at a median follow-up for overall survival of 11.6 months and 10.7 months in the two groups, 37 patients and 44 patients had died, respectively. Adverse events during treatment occurred in 99.5% of patients in the avelumab-plus-axitinib group and in 99.3% of patients in the sunitinib group; these events were grade 3 or higher in 71.2% and 71.5% of the patients in the respective groups. Progression-free survival was significantly longer with avelumab plus axitinib than with sunitinib among patients who received these agents as first-line treatment for advanced renal-cell carcinoma. (Funded by Pfizer and Merck [Darmstadt, Germany]; JAVELIN Renal 101 ClinicalTrials.gov number, NCT02684006.). BackgroundIn a single-group, phase 1b trial, avelumab plus axitinib resulted in objective responses in patients with advanced renal-cell carcinoma. This phase 3 trial involving previously untreated patients with advanced renal-cell carcinoma compared avelumab plus axitinib with the standard-of-care sunitinib.MethodsWe randomly assigned patients in a 1:1 ratio to receive avelumab (10 mg per kilogram of body weight) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary end points were progression-free survival and overall survival among patients with programmed death ligand 1 (PD-L1)–positive tumors. A key secondary end point was progression-free survival in the overall population; other end points included objective response and safety.ResultsA total of 886 patients were assigned to receive avelumab plus axitinib (442 patients) or sunitinib (444 patients). Among the 560 patients with PD-L1–positive tumors (63.2%), the median progression-free survival was 13.8 months with avelumab plus axitinib, as compared with 7.2 months with sunitinib (hazard ratio for disease progression or death, 0.61; 95% confidence interval [CI], 0.47 to 0.79; P<0.001); in the overall population, the median progression-free survival was 13.8 months, as compared with 8.4 months (hazard ratio, 0.69; 95% CI, 0.56 to 0.84; P<0.001). Among the patients with PD-L1–positive tumors, the objective response rate was 55.2% with avelumab plus axitinib and 25.5% with sunitinib; at a median follow-up for overall survival of 11.6 months and 10.7 months in the two groups, 37 patients and 44 patients had died, respectively. Adverse events during treatment occurred in 99.5% of patients in the avelumab-plus-axitinib group and in 99.3% of patients in the sunitinib group; these events were grade 3 or higher in 71.2% and 71.5% of the patients in the respective groups.ConclusionsProgression-free survival was significantly longer with avelumab plus axitinib than with sunitinib among patients who received these agents as first-line treatment for advanced renal-cell carcinoma. (Funded by Pfizer and Merck [Darmstadt, Germany]; JAVELIN Renal 101 ClinicalTrials.gov number, NCT02684006.) In a single-group, phase 1b trial, avelumab plus axitinib resulted in objective responses in patients with advanced renal-cell carcinoma. This phase 3 trial involving previously untreated patients with advanced renal-cell carcinoma compared avelumab plus axitinib with the standard-of-care sunitinib.BACKGROUNDIn a single-group, phase 1b trial, avelumab plus axitinib resulted in objective responses in patients with advanced renal-cell carcinoma. This phase 3 trial involving previously untreated patients with advanced renal-cell carcinoma compared avelumab plus axitinib with the standard-of-care sunitinib.We randomly assigned patients in a 1:1 ratio to receive avelumab (10 mg per kilogram of body weight) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary end points were progression-free survival and overall survival among patients with programmed death ligand 1 (PD-L1)-positive tumors. A key secondary end point was progression-free survival in the overall population; other end points included objective response and safety.METHODSWe randomly assigned patients in a 1:1 ratio to receive avelumab (10 mg per kilogram of body weight) intravenously every 2 weeks plus axitinib (5 mg) orally twice daily or sunitinib (50 mg) orally once daily for 4 weeks (6-week cycle). The two independent primary end points were progression-free survival and overall survival among patients with programmed death ligand 1 (PD-L1)-positive tumors. A key secondary end point was progression-free survival in the overall population; other end points included objective response and safety.A total of 886 patients were assigned to receive avelumab plus axitinib (442 patients) or sunitinib (444 patients). Among the 560 patients with PD-L1-positive tumors (63.2%), the median progression-free survival was 13.8 months with avelumab plus axitinib, as compared with 7.2 months with sunitinib (hazard ratio for disease progression or death, 0.61; 95% confidence interval [CI], 0.47 to 0.79; P<0.001); in the overall population, the median progression-free survival was 13.8 months, as compared with 8.4 months (hazard ratio, 0.69; 95% CI, 0.56 to 0.84; P<0.001). Among the patients with PD-L1-positive tumors, the objective response rate was 55.2% with avelumab plus axitinib and 25.5% with sunitinib; at a median follow-up for overall survival of 11.6 months and 10.7 months in the two groups, 37 patients and 44 patients had died, respectively. Adverse events during treatment occurred in 99.5% of patients in the avelumab-plus-axitinib group and in 99.3% of patients in the sunitinib group; these events were grade 3 or higher in 71.2% and 71.5% of the patients in the respective groups.RESULTSA total of 886 patients were assigned to receive avelumab plus axitinib (442 patients) or sunitinib (444 patients). Among the 560 patients with PD-L1-positive tumors (63.2%), the median progression-free survival was 13.8 months with avelumab plus axitinib, as compared with 7.2 months with sunitinib (hazard ratio for disease progression or death, 0.61; 95% confidence interval [CI], 0.47 to 0.79; P<0.001); in the overall population, the median progression-free survival was 13.8 months, as compared with 8.4 months (hazard ratio, 0.69; 95% CI, 0.56 to 0.84; P<0.001). Among the patients with PD-L1-positive tumors, the objective response rate was 55.2% with avelumab plus axitinib and 25.5% with sunitinib; at a median follow-up for overall survival of 11.6 months and 10.7 months in the two groups, 37 patients and 44 patients had died, respectively. Adverse events during treatment occurred in 99.5% of patients in the avelumab-plus-axitinib group and in 99.3% of patients in the sunitinib group; these events were grade 3 or higher in 71.2% and 71.5% of the patients in the respective groups.Progression-free survival was significantly longer with avelumab plus axitinib than with sunitinib among patients who received these agents as first-line treatment for advanced renal-cell carcinoma. (Funded by Pfizer and Merck [Darmstadt, Germany]; JAVELIN Renal 101 ClinicalTrials.gov number, NCT02684006.).CONCLUSIONSProgression-free survival was significantly longer with avelumab plus axitinib than with sunitinib among patients who received these agents as first-line treatment for advanced renal-cell carcinoma. (Funded by Pfizer and Merck [Darmstadt, Germany]; JAVELIN Renal 101 ClinicalTrials.gov number, NCT02684006.).
Author	Venugopal, Balaji Miller, Wilson H Rini, Brian Penkov, Konstantin Atkins, Michael B Fowst, Camilla di Pietro, Alessandra Campbell, Matthew T Negrier, Sylvie Choueiri, Toni K Gurney, Howard Bedke, Jens Haanen, John Alekseev, Boris Hariharan, Subramanian Larkin, James Lee, Jae L Wang, Jing Robbins, Paul B Schmidinger, Manuela Uemura, Motohide Huang, Bo Kollmannsberger, Christian Vasiliev, Aleksandr Motzer, Robert J Mariani, Mariangela Chudnovsky, Aleksander Albiges, Laurence
Author_xml	– sequence: 1 givenname: Robert J surname: Motzer fullname: Motzer, Robert J organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; 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British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 7 givenname: Balaji surname: Venugopal fullname: Venugopal, Balaji organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; 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the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); 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British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 10 givenname: Motohide surname: Uemura fullname: Uemura, Motohide organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 11 givenname: Jae L surname: Lee fullname: Lee, Jae L organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 12 givenname: Aleksandr surname: Vasiliev fullname: Vasiliev, Aleksandr organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 13 givenname: Wilson H surname: Miller fullname: Miller, Wilson H organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 14 givenname: Howard surname: Gurney fullname: Gurney, Howard organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 15 givenname: Manuela surname: Schmidinger fullname: Schmidinger, Manuela organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 16 givenname: James surname: Larkin fullname: Larkin, James organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 17 givenname: Michael B surname: Atkins fullname: Atkins, Michael B organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 18 givenname: Jens surname: Bedke fullname: Bedke, Jens organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 19 givenname: Boris surname: Alekseev fullname: Alekseev, Boris organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 20 givenname: Jing surname: Wang fullname: Wang, Jing organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 21 givenname: Mariangela surname: Mariani fullname: Mariani, Mariangela organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 22 givenname: Paul B surname: Robbins fullname: Robbins, Paul B organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 23 givenname: Aleksander surname: Chudnovsky fullname: Chudnovsky, Aleksander organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 24 givenname: Camilla surname: Fowst fullname: Fowst, Camilla organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 25 givenname: Subramanian surname: Hariharan fullname: Hariharan, Subramanian organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 26 givenname: Bo surname: Huang fullname: Huang, Bo organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 27 givenname: Alessandra surname: di Pietro fullname: di Pietro, Alessandra organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.) – sequence: 28 givenname: Toni K surname: Choueiri fullname: Choueiri, Toni K organization: From Memorial Sloan Kettering Cancer Center (R.J.M.) and Pfizer (S.H.), New York; Private Medical Institution Euromedservice (K.P.) and Nonstate Health Institution Road Clinical Hospital–Russian Railways (A.V.), St. Petersburg, and the Moscow Scientific Research Oncology Institute, Moscow (B.A.) — all in Russia; the Netherlands Cancer Institute, Amsterdam (J.H.); the Cleveland Clinic, Cleveland (B.R.); Institut Gustave Roussy, Villejuif (L.A.), and Centre Léon Bérard, University of Lyon, Lyon (S.N.) — both in France; the University of Texas M.D. Anderson Cancer Center, Houston (M.T.C.); University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow (B.V.), and Royal Marsden NHS Foundation Trust, London (J.L.) — both in the United Kingdom; British Columbia Cancer Agency, Vancouver (C.K.), and Lady Davis Institute and Jewish General Hospital, McGill University, Montreal (W.H.M.) — both in Canada; Osaka University Hospital, Osaka, Japan (M.U.); University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea (J.L.L.); Macquarie University, Sydney (H.G.); Department of Medicine I, Clinical Division of Oncology and Comprehensive Cancer Center, Medical University of Vienna, Vienna (M.S.); Georgetown Lombardi Comprehensive Cancer Center, Washington, DC (M.B.A.); Department of Urology, University of Tübingen, Tübingen, Germany (J.B.); Pfizer, Cambridge (J.W., A.C.), and the Lank Center for Genitourinary Oncology at Dana–Farber Cancer Institute, and Brigham and Women’s Hospital, Boston (T.K.C.) — both in Massachusetts; Pfizer (M.M., A.P.) and Pfizer Italia (C.F.), Milan; Pfizer, San Diego, CA (P.B.R.); and Pfizer, Groton, CT (B.H.)
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/30779531$$D View this record in MEDLINE/PubMed
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Snippet	Among 886 patients with advanced renal-cell cancer, median progression-free survival was 13.8 months among those assigned to avelumab plus axitinib and 7.2... In a single-group, phase 1b trial, avelumab plus axitinib resulted in objective responses in patients with advanced renal-cell carcinoma. This phase 3 trial... BackgroundIn a single-group, phase 1b trial, avelumab plus axitinib resulted in objective responses in patients with advanced renal-cell carcinoma. This phase...
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SubjectTerms	Administration, Intravenous Adult Aged Aged, 80 and over Antibodies, Monoclonal - administration & dosage Antibodies, Monoclonal - adverse effects Antibodies, Monoclonal, Humanized Antineoplastic Agents - therapeutic use Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Apoptosis Axitinib - administration & dosage Axitinib - adverse effects Body weight Cancer therapies Carcinoma, Renal Cell - drug therapy Carcinoma, Renal Cell - mortality Drug dosages Evidence-based medicine Female Humans Immunotherapy Inhibitor drugs Kidney cancer Kidney Neoplasms - drug therapy Kidney Neoplasms - mortality Kinases Male Middle Aged Monoclonal antibodies Oncology PD-L1 protein Programmed Cell Death 1 Receptor - antagonists & inhibitors Progression-Free Survival Renal cell carcinoma Single-Blind Method Sunitinib - adverse effects Sunitinib - therapeutic use Survival Rate Targeted cancer therapy Tumors Vascular endothelial growth factor
Title	Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma
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