At data cutoff (Oct 19, 2016), median duration of follow-up was 5.4 mo (range, 0.5 to 18.7). 51.7% and 48.3% received pembro as 3rd-line (3L) and 4L+ therapy, respectively. Results: Of 259 pts in cohort 1, 76.4% were men median age was 62.0 y. Primary end points: ORR (RECIST 1.1, by central review), safety, and tolerability. PD-L1 +pts had expression in ≥1% tumor or stromal cells using IHC (22C3 antibody). Pts received pembro 200 mg Q3W up to 2 y or up to disease progression, investigator/pt decision to withdrawal, or unacceptable toxicity.
Methods: Cohort 1 enrolled 259 pts, aged ≥18 y with measurable recurrent or metastatic G/GEJ adenocarcinoma who had progressed on ≥2 prior chemotherapy regimens and had ECOG PS 0-1.
We conducted a global, multicohort, phase 2 study of pembro in pts with advanced gastric or gastroesophageal junction (G/GEJ) cancer (KEYNOTE-059 NCT02335411). Yale Cancer Center, New Haven, CT National Cancer Center Hospital East, Chiba, Japan Princess Margaret Cancer Centre, Toronto, ON, Canada Aichi Cancer Center Hospital, Aichi, Japan Osaka University Graduate School of Medicine, Osaka, Japan Portuguese Institute of Oncology Libon, Porto, Portugal University of Pittsburgh Medical Center, Pittsburgh, PA Indiana University School of Medicine, Indianapolis, IN Weill Cornell Medical College, New York-Presbyterian Hospital, New York, NY Centre Hospitalier Regional Universitaire (CHRU) de Brest - Hopital Morvan, Brest, France Pontificia Universidad Católica de Chile, Santiago, Chile Sheba Medical Center, Tel HaShomer, Ramat Gan, Israel ASST Papa Giovanni XXIII, Cancer Center, Bergamo, Italy Ronald Reagan UCLA Medical Center, Los Angeles, CA University of Chicago Pritzker School of Medicine, Chicago, IL Seoul National University Hospital, Seoul, Republic of Korea Merck & Co., Inc., Kenilworth, NJ Mayo Clinic, Rochester, MNīackground: Pembro has shown promising antitumor activity and manageable safety in a phase 1 study of pts with previously treated advanced gastric cancer.
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