The combination "could potentially be a new first-line treatment option" in this patient population, researchers write in The Lancet Oncology.
The study enrolled 724 treatment-naive patients (regardless of PD-L1 expression) from centers in Japan, South Korea and Taiwan. Patients received chemotherapy every three weeks (intravenous oxaliplatin 130 mg/m2 on day one plus either oral S-1 40 mg/m2 (SOX) or oral capecitabine 1,000 mg/m2 (CAPOX), twice daily on days one to 14), in addition to either 360 mg nivolumab intravenously every three weeks or matching placebo.
At the interim analysis, with a median follow-up of 11.6 months, median PFS was longer in the nivolumab than the placebo group (10.45 vs. 8.34 months; hazard ratio, 0.68; 95% CI, 0.51 to 0.90).
Dr. Narikazu Boku of the National Cancer Center Hospital, in Tokyo, and colleagues note that "importantly, the separation of Kaplan-Meier curves was sustained, suggesting a durable benefit of nivolumab."
"In addition, patients given nivolumab plus chemotherapy had a higher response rate associated with a longer duration of response than did those given placebo plus chemotherapy. These results suggest the direct efficacy of nivolumab in addition to chemotherapy," they write.
At the final analysis, however, with a median follow-up of 26.6 months, the difference in median overall survival was not significantly different with nivolumab versus placebo (17.45 vs. 17.15 months; HR, 0.90; 95% CI, 0.75 to 1.08).
The safety profile of nivolumab plus chemotherapy was in line with the known safety profile of nivolumab and each chemotherapy, with no new safety signals detected. Quality of life was maintained with the addition of nivolumab to chemotherapy.
The researchers note that the benefit of nivolumab combined with an oxaliplatin-based regimen in the ATTRACTION-4 study is supported by results from CheckMate-649.
"Nivolumab combined with SOX or CAPOX could potentially be a new first-line treatment option in Asian patients with HER2-negative, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer," they conclude.
The study was funded by Ono Pharmaceutical and Bristol-Myers Squibb. Several authors have disclosed relationships with the companies.
SOURCE: https://bit.ly/3FEvnrN The Lancet Oncology, online January 11, 2022.
By Reuters Staff
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