These results indicate that nivolumab could be a new treatment option for patients with heavily pretreated advanced gastric cancer and also provide a strong rationale to explore nivolumab in earlier lines of treatment.

— Yoon-Koo Kang, MD

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Gastric cancer can apparently be added to the growing list of malignancies for which drugs targeting the programmed cell death protein 1 (PD‑1) receptor are effective, according to the results of the phase III ONO-4538 investigation conducted in Asia and presented at the 2017 Gastrointestinal Cancers Symposium held recently in San Francisco.¹

Among 493 patients with heavily pretreated advanced gastric cancer in the study, those randomized to receive treatment with nivolumab (3 mg/kg) had a median overall survival of 5.32 months, compared with 4.14 months for placebo—a 37% reduction in mortality (P < .0001). In addition, the 12-month overall survival in the nivolumab group was 26.6% vs 10.9% with ­placebo.

By improving overall survival, the study met its primary endpoint, reported Yoon-Koo Kang, MD, of Asan Medical Center and the University of Ulsan in Seoul, Republic of Korea.

Additional Study Details

Median progression-free survival was 1.61 months with nivolumab and 1.45 months with placebo—a 40% reduction in disease progression or death (P < .0001). One-year progression-free survival was 7.6% and 1.5%, respectively. Treatment with nivolumab also improved response rates, from 0% to 11.2% (P < .0001), with a 9.53-month median duration of response, noted Dr. Kang.

“These results indicate that nivolu­mab could be a new treatment option for patients with heavily pretreated advanced gastric cancer and also provide a strong rationale to explore nivolumab in earlier lines of treatment,” Dr. Kang commented.

The safety profile of nivolumab was consistent with previously reported studies in solid tumors. Treatment-related adverse events of any grade and grade 3/4 occurred in 42.7% vs 26.7%, and 10.3% vs 4.3%, respectively, for nivolumab-treated and placebo-treated patients. ■

Disclosure: Dr. Kang has had a consulting or advisory role with Lilly/ImClone, Novartis, Ono Pharma­ceutical, Roche/Genentech, Daehwa Pharma­ceutical, LSK Biopharma, and Taiho Pharmaceutical and has received research funding from Bayer, Novartis, Daehwa Pharma­ceutical, LSK Biopharma, and Roche/Genentech.

Reference

1. Kang Y-K, Satoh T, Ryu M-H, et al: Nivolumab (ONO-4538/BMS-936558) as salvage treatment after second or later-line chemotherapy for advanced gastric or gastro-esophageal junction cancer. 2017 Gastrointestinal Cancers Symposium. Abstract 2. Presented January 19, 2017.