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]). Here, we report updated results, and the relationship between efficacy of Nivo and PD-L1 expression levels.
493 patients(pts) aged ≥ 20 years with ECOG PS 0-1 and unresectable advanced or recurrent G/GEJ cancer after failure of two or more previous chemotherapy regimens were randomized in a 2:1 ratio to receive 3 mg/kg Nivo (N = 330) or placebo (N = 163) every 2 weeks until unacceptable toxicity or disease progression. The primary endpoint was overall survival (OS). The PD-L1 expression was assessed by immunohistochemistry (28-8 pharmDx assay). And updated results of the efficacy and safety were based on ≥ 1-year follow-up after last patient enrollment.
As of the data cut-off on February 25th 2017, one year after last patient enrollment, the median OS (mOS) was 5.32 months with Nivo versus 4.14 months with placebo (hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.50-0.75; p
With minimum 1-year of follow-up, long-term survival benefit of nivolumab was confirmed for patients with advanced G/GEJ cancer. Although tumor samples were available only in 40% of all enrolled patients, Nivo demonstrated benefit irrespective of PD-L1 expression in the exploratory analysis.
Clinical trial identification
Legal entity responsible for the study
Ono Pharmaceutical Co., Ltd
Ono Pharmaceutical Co., Ltd, Bristol-Myers Squibb
N. Boku: Ono, Taiho, Chugai, Eli-Lilly. Y-K. Kang: Ono, Bristol-Myers Squibb, Lilly/ImClone, Taiho Pharmaceutical, Roche/Genentech, Novartis, Bayer. T. Satoh: Ono. K. Kato: Ono, Shionogi, MSD. H.C. Chung: Lilly, GSK, MSD, Merck Serono, BMS, Ono, Taiho, Celltrion, Quintiles, BMS. K. Muro: Shionogi, MSD K.K., Daiichi Sankyo, Kyowa Hakko Kirin, Gilead Sciences, Chugai, Takeda, Eli Lilly Japan K.K., Merck Serono, Taiho, Yakult Honsha. T. Yoshikawa: Taiho, Chugai, Yakult, Ono, MSD. K-W. Lee: Ono. L-T. Chen: Ono, Eli-Lilly, MSD, PharmaEngine, Merrimack, TTY, Syncore, Five Prime, Novartis, GSK, Merck Serono, Polaris, Anti-Alpha Enolase (ENO-1) monoclonal antibody/HuniLife. All other authors have declared no conflicts of interest.