Opdivo for gastric cancer – pro
CheckMate-032 is a randomized, open-label, multitumor cohort study that accrued patients with multiple cancer types and treated them with Opdivo as a single agent or in combination with ipilimumab, including 163 patients with gastric cancer. Fifty-nine patients with locoregionally advanced or metastatic gastric cancer or GEJ were assigned to single-agent Opdivo at 3 mg/kg IV every 2 weeks. The remaining 104 patients were assigned to 1 of 3 Opdivo/ipilimumab combination regimens.The median ORR was 14 percent, including one complete response (CR) and seven partial responses (PR). The rates of stable disease (SD) and progressive disease were 19 percent (11 patients) and 58 percent (34 patients), respectively. Responses were not determined for six patients. The disease control rate (CR + PR + SD) was 32 percent (19 patients). The median time to response was 1.6 months, with a median response duration of 7.1 months.
In November of 2016, Bristol Myers Squibb announced that the ONO-4538-12, a Phase 3, randomized, double-blind clinical trial evaluating the efficacy and safety of Opdivo (nivolumab) in patients with unresectable advanced or recurrent gastric cancer refractory to, or intolerant of, standard therapy, met its primary endpoint of increased overall survival (OS). ONO-4538-12 is a multicenter, double-blind, randomized, placebo-controlled, Phase 3 clinical trial conducted in Japan, Korea and Taiwan, aiming to evaluate the efficacy and safety of Opdivo in patients with unresectable advanced or recurrent gastric cancer, including gastroesophageal junction cancer, refractory to, or intolerant of, standard therapy. In this study, Opdivo 3 mg/kg or placebo was administered every two weeks until disease progression or discontinuation due to unacceptable toxicity. Opdivo reduced the risk of death by 37%, significantly increasing patients’ median overall survival from 4.14 months to 5.32 months.
CLINICAL / MEDICAL REFERENCES
Le DT, Bendell JC, Calvo E, et al. Safety and activity of nivolumab monotherapy in advanced and metastatic (A/M) gastric or gastroesophageal junction cancer (GC/GEC): results from the CheckMate-032 study. J Clin Oncol 34, 2016 (suppl 4S; abstr 6).
Opdivo, Prescribing Information 2016
Opdivo (nivolumab) demonstrates overall survival benefit in patients with unresectable advanced or recurrent gastric cancer in phase 3 study. Bristol-Myers Squibb website. http://news.bms.com/press-release/bmy/opdivo-nivolumab-demonstrates-overall-survival-benefit-patients-unresectable-advan. Updated November 10, 2016.