Nivo monotherapy demonstrated its efficacy with manageable safety for G/GEJ cancer refractory or intolerant to standard chemotherapy at the primary analysis (ATTRACTION-02[ONO-4538-12]: ASCO-GI 2017, Kang YK et al. J Clin Oncol. 2017; 35 [suppl 4S abstract 2]). This randomized phase 2/3 trial is to evaluate the efficacy and safety of Nivo in combination with 1st line chemotherapy in unresectable advanced or recurrent G/GEJ cancer (NCT02746796).
This trial includes previously untreated pts aged ≥ 20 years with ECOG PS 0-1 and had measurable, unresectable advanced or recurrent HER2 (-) G/GEJ cancer. It consists of 2 parts. Part 1 is a randomized, open-label trial to evaluate the feasibility of Nivo (360 mg, Q3W) in combination with oxaliplatin (130 mg/m2, Q3W) plus either S-1 (40 mg/m2 twice daily, day 1-14, SOX) or capecitabine (1000 mg/m2 twice daily, day 1-14, CapeOX) in terms of activity and safety. Part 2 is a randomized, double-blind, placebo-controlled trial comparing Nivo to placebo in combination with SOX/CapeOX in terms of overall survival and progression free survival (PFS).
A total of 40 pts were included into part 1, 21 pts were randomized to Nivo+SOX and 19 to Nivo+CapeOX. The median age was 62.5 years, 27 pts (67.5%) were male, 20 pts (50.0%) had ECOG PS 1. Median duration of treatment was 7.03 months (range 0.1-9.9) as of 24 Feb 2017. Both treatments were well tolerated. Grade 3-4 treatment-related adverse events (AEs) were reported 23 pts (57.5%). No Nivo-related AEs leading to discontinuation were reported. Overall response rate was 68.4% (26/38, CR10, PR16) and disease control rate was 86.8%. Median PFS was not reached. 18 pts (46.2%) remain on treatment at the time of the data cut off. There were no significant differences in activity and safety between the 2 treatments.
Nivo+SOX/CapeOX were feasible with promising activity as the 1st-line chemotherapy in pts with previously untreated unresectable advanced or recurrent G/GEJ cancer. Part 2 of the study is ongoing.
Clinical trial identification
Legal entity responsible for the study
Ono Pharmaceutical Co., ltd.
Ono Pharmaceutical Co., ltd., Bristol-Myers Squibb
Y-K. Kang: Ono, Bristol-Myers Squibb, Lilly/ImClone, Taiho Pharmaceutical, Roche/Genentech, Novartis, Bayer. K. Kato: Ono Pharmaceutical Co., Ltd., Shionogi, MSD. H.C. Chung: Lilly, GSK, MSD, Merck-Serono, BMS/Ono, Taiho, Celltrion, Quintiles, BMS. K-W. Lee, K. Yamaguchi: Ono. Y. Komatsu: Taiho, Lilly, MSD, Ono, Novartis, Bayer, Chugai, Yakult, Pfizer, Merck. H. Hara: Chugai Pharma, Taiho Pharmaceutical, Merck Serono, Yakult Honsha, Lilly, AstraZeneca, MSD, Ono Pharmaceutical, Takeda, Boehringer Ingelheim, Dainippon Sumitomo Pharma, Daiichi Sankyo. N. Boku: Ono, Taiho, Chugai, Eli-Lily. L-T. Chen: Novartis, GSK, Merck Serono, TTY, Polaris, ONO, Eli Lilly, MSD, PharmaEngine, Merrimack, Syncore, Five Prime, anti-alpha enolase (ENO-1) monoclonal antibody/HuniLife. All other authors have declared no conflicts of interest.