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.
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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.
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.
Heinz-Josef Lenz, MD
Heinz-Josef Lenz, MD, of the University of Southern California in Los Angeles, said the results of the ONO-4538 trial were impressive in light of this challenging patient population. “You see a significant benefit in a highly refractory gastric cancer population,” he...!-->!-->