Dirk Schadendorf1, F Stephen Hodi2, Caroline Robert2, Jeffrey S Weber2, Kim Margolin2, Omid Hamid2, Debra Patt2, Tai-Tsang Chen2, David M Berman2, Jedd D Wolchok2. 1. Dirk Schadendorf, University Hospital Essen, Essen, Germany; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Jeffrey S. Weber, Moffitt Cancer Center, Tampa, FL; Kim Margolin, University of Washington, Seattle, WA; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Debra Patt, The US Oncology Network, McKesson Specialty Health, Houston, TX; Tai-Tsang Chen, Bristol-Myers Squibb, Wallingford, CT; David M. Berman, Bristol-Myers Squibb, Lawrenceville, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY. Dirk.Schadendorf@uk-essen.de. 2. Dirk Schadendorf, University Hospital Essen, Essen, Germany; F. Stephen Hodi, Dana-Farber Cancer Institute, Boston, MA; Caroline Robert, Institute Gustave Roussy, Villejuif, France; Jeffrey S. Weber, Moffitt Cancer Center, Tampa, FL; Kim Margolin, University of Washington, Seattle, WA; Omid Hamid, The Angeles Clinic and Research Institute, Los Angeles, CA; Debra Patt, The US Oncology Network, McKesson Specialty Health, Houston, TX; Tai-Tsang Chen, Bristol-Myers Squibb, Wallingford, CT; David M. Berman, Bristol-Myers Squibb, Lawrenceville, NJ; and Jedd D. Wolchok, Memorial Sloan Kettering Cancer Center, New York, NY.
Abstract
PURPOSE: To provide a more precise estimate of long-term survival observed for ipilimumab-treated patients with advanced melanoma, we performed a pooled analysis of overall survival (OS) data from multiple studies. METHODS: The primary analysis pooled OS data for 1,861 patients from 10 prospective and two retrospective studies of ipilimumab, including two phase III trials. Patients were previously treated (n = 1,257) or treatment naive (n = 604), and the majority of patients received ipilimumab 3 mg/kg (n = 965) or 10 mg/kg (n = 706). We also conducted a secondary analysis of OS data (n = 4,846) with an additional 2,985 patients from an expanded access program. OS rates were estimated using the Kaplan-Meier method. RESULTS: Among 1,861 patients, median OS was 11.4 months (95% CI, 10.7 to 12.1 months), which included 254 patients with at least 3 years of survival follow-up. The survival curve began to plateau around year 3, with follow-up of up to 10 years. Three-year survival rates were 22%, 26%, and 20% for all patients, treatment-naive patients, and previously treated patients, respectively. Including data from the expanded access program, median OS was 9.5 months (95% CI, 9.0 to 10.0 months), with a plateau at 21% in the survival curve beginning around year 3. CONCLUSION: To our knowledge, this is the largest analysis of OS to date for ipilimumab-treated patients with advanced melanoma. We observed a plateau in the survival curve, beginning at approximately 3 years, which was independent of prior therapy or ipilimumab dose. These data add to the evidence supporting the durability of long-term survival in ipilimumab-treated patients with advanced melanoma.
PURPOSE: To provide a more precise estimate of long-term survival observed for ipilimumab-treated patients with advanced melanoma, we performed a pooled analysis of overall survival (OS) data from multiple studies. METHODS: The primary analysis pooled OS data for 1,861 patients from 10 prospective and two retrospective studies of ipilimumab, including two phase III trials. Patients were previously treated (n = 1,257) or treatment naive (n = 604), and the majority of patients received ipilimumab 3 mg/kg (n = 965) or 10 mg/kg (n = 706). We also conducted a secondary analysis of OS data (n = 4,846) with an additional 2,985 patients from an expanded access program. OS rates were estimated using the Kaplan-Meier method. RESULTS: Among 1,861 patients, median OS was 11.4 months (95% CI, 10.7 to 12.1 months), which included 254 patients with at least 3 years of survival follow-up. The survival curve began to plateau around year 3, with follow-up of up to 10 years. Three-year survival rates were 22%, 26%, and 20% for all patients, treatment-naive patients, and previously treated patients, respectively. Including data from the expanded access program, median OS was 9.5 months (95% CI, 9.0 to 10.0 months), with a plateau at 21% in the survival curve beginning around year 3. CONCLUSION: To our knowledge, this is the largest analysis of OS to date for ipilimumab-treated patients with advanced melanoma. We observed a plateau in the survival curve, beginning at approximately 3 years, which was independent of prior therapy or ipilimumab dose. These data add to the evidence supporting the durability of long-term survival in ipilimumab-treated patients with advanced melanoma.
Authors: Caroline Robert; Luc Thomas; Igor Bondarenko; Steven O'Day; Jeffrey Weber; Claus Garbe; Celeste Lebbe; Jean-François Baurain; Alessandro Testori; Jean-Jacques Grob; Neville Davidson; Jon Richards; Michele Maio; Axel Hauschild; Wilson H Miller; Pere Gascon; Michal Lotem; Kaan Harmankaya; Ramy Ibrahim; Stephen Francis; Tai-Tsang Chen; Rachel Humphrey; Axel Hoos; Jedd D Wolchok Journal: N Engl J Med Date: 2011-06-05 Impact factor: 91.245
Authors: F Stephen Hodi; Steven J O'Day; David F McDermott; Robert W Weber; Jeffrey A Sosman; John B Haanen; Rene Gonzalez; Caroline Robert; Dirk Schadendorf; Jessica C Hassel; Wallace Akerley; Alfons J M van den Eertwegh; Jose Lutzky; Paul Lorigan; Julia M Vaubel; Gerald P Linette; David Hogg; Christian H Ottensmeier; Celeste Lebbé; Christian Peschel; Ian Quirt; Joseph I Clark; Jedd D Wolchok; Jeffrey S Weber; Jason Tian; Michael J Yellin; Geoffrey M Nichol; Axel Hoos; Walter J Urba Journal: N Engl J Med Date: 2010-06-05 Impact factor: 91.245
Authors: Kim Margolin; Marc S Ernstoff; Omid Hamid; Donald Lawrence; David McDermott; Igor Puzanov; Jedd D Wolchok; Joseph I Clark; Mario Sznol; Theodore F Logan; Jon Richards; Tracy Michener; Agnes Balogh; Kevin N Heller; F Stephen Hodi Journal: Lancet Oncol Date: 2012-03-27 Impact factor: 41.316
Authors: Jedd D Wolchok; Bart Neyns; Gerald Linette; Sylvie Negrier; Jose Lutzky; Luc Thomas; William Waterfield; Dirk Schadendorf; Michael Smylie; Troy Guthrie; Jean-Jacques Grob; Jason Chesney; Kevin Chin; Kun Chen; Axel Hoos; Steven J O'Day; Celeste Lebbé Journal: Lancet Oncol Date: 2009-12-08 Impact factor: 41.316
Authors: Jedd D Wolchok; Axel Hoos; Steven O'Day; Jeffrey S Weber; Omid Hamid; Celeste Lebbé; Michele Maio; Michael Binder; Oliver Bohnsack; Geoffrey Nichol; Rachel Humphrey; F Stephen Hodi Journal: Clin Cancer Res Date: 2009-11-24 Impact factor: 12.531
Authors: Jedd D Wolchok; Harriet Kluger; Margaret K Callahan; Michael A Postow; Naiyer A Rizvi; Alexander M Lesokhin; Neil H Segal; Charlotte E Ariyan; Ruth-Ann Gordon; Kathleen Reed; Matthew M Burke; Anne Caldwell; Stephanie A Kronenberg; Blessing U Agunwamba; Xiaoling Zhang; Israel Lowy; Hector David Inzunza; William Feely; Christine E Horak; Quan Hong; Alan J Korman; Jon M Wigginton; Ashok Gupta; Mario Sznol Journal: N Engl J Med Date: 2013-06-02 Impact factor: 91.245
Authors: Jedd D Wolchok; F Stephen Hodi; Jeffrey S Weber; James P Allison; Walter J Urba; Caroline Robert; Steven J O'Day; Axel Hoos; Rachel Humphrey; David M Berman; Nils Lonberg; Alan J Korman Journal: Ann N Y Acad Sci Date: 2013-06-17 Impact factor: 5.691
Authors: Fade Mahmoud; Bradley Shields; Issam Makhoul; Nathan Avaritt; Henry K Wong; Laura F Hutchins; Sara Shalin; Alan J Tackett Journal: Cancer Biol Ther Date: 2017-05-17 Impact factor: 4.742
Authors: Valsamo Anagnostou; Mark Yarchoan; Aaron R Hansen; Hao Wang; Franco Verde; Elad Sharon; Deborah Collyar; Laura Q M Chow; Patrick M Forde Journal: Clin Cancer Res Date: 2017-09-01 Impact factor: 12.531
Authors: Charu Aggarwal; Andrew R Haas; Susan Metzger; Laura K Aguilar; Estuardo Aguilar-Cordova; Andrea G Manzanera; Gregoria Gómez-Hernández; Sharyn I Katz; Evan W Alley; Tracey L Evans; Joshua M Bauml; Roger B Cohen; Corey J Langer; Steven M Albelda; Daniel H Sterman Journal: Mol Ther Date: 2018-02-21 Impact factor: 11.454
Authors: Kimiteru Ito; Heiko Schöder; Rebecca Teng; John L Humm; Ai Ni; Jedd D Wolchok; Wolfgang A Weber Journal: Eur J Nucl Med Mol Imaging Date: 2018-11-28 Impact factor: 9.236