Nivolumab Approved in Japan for Unresectable Advanced or Recurrent Gastric Cancer That Has Progressed After Chemotherapy

On September 22, Bristol-Myers Squibb Company announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) approved nivolumab (Opdivo) for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy. This approval was based on the phase III study ATTRACTION-2 (ONO-4538-12), in which nivolumab significantly reduced patients’ risk of death by 37% (hazard ratio [HR] = 0.63; 95% confidence interval [CI] = 0.51­–0.78, P < .0001) when compared to placebo. Furthermore, nivolumab demonstrated a greater overall survival rate at 12 months vs placebo: 26.2% (95% CI = 20.7–32.0) and 10.9% (95% CI = 6.2–17.0), respectively. The safety profile of nivolumab in this study was consistent with previously reported studies in solid tumors, and discontinuation rates due to treatment-related adverse events in the nivolumab and placebo arms were comparable.

“The approval of nivolumab for advanced or recurrent gastric cancer in Japan offers health-care providers and patients a much-needed new treatment option, and reinforces our commitment to advance the treatment of cancer through immuno-oncology–based approaches,” said Murdo Gordon, Executive Vice President and Chief Commercial Officer, Bristol-Myers Squibb.

The prevalence of gastric cancer is highest in Asian countries, and it is the second most common cancer diagnosis in Japan, with nearly 134,000 people diagnosed in 2016. While treatment options are available for patients in earlier lines of therapy, nearly all patients with advanced gastric cancer continue to experience disease progression, reinforcing the need for innovative new treatment options.

“I have seen firsthand how patients and their families are negatively impacted by gastric cancer, which in Japan took approximately 50,000 lives last year,” said Taroh Satoh, MD, Frontier Science for Cancer and Chemotherapy, Graduate School of Medicine, Osaka University, Suita, Japan. “It is encouraging that Japanese patients with advanced or recurrent gastric cancer now have an immuno-oncology treatment option with the approval of nivolumab, which has shown in clinical trials to improve survival across all patient types, including those whose tumors express [programmed cell death ligand 1 (PD-L1)].”

ATTRACTION-2 (ONO-4538-12)

The approval is based on the results of ATTRACTION-2 (ONO-4538-12), a phase III randomized, double-blind, placebo-controlled clinical trial conducted in Japan, South Korea, and Taiwan, evaluating the efficacy and safety of nivolumabin patients with surgically unresectable previously treated advanced or recurrent gastric cancer, including gastroesophageal junction cancer, refractory to or intolerant of at least two chemotherapy regimens.

The ATTRACTION-2 (ONO-4538-12) study evaluated the efficacy of nivolumab using overall survival as the primary endpoint. The secondary endpoints included objective response rate, duration of response, progression-free survival, best overall response, time to response, disease control rate, and safety measures.

In the trial, nivolumab 3 mg/kg or placebo was administered every 2 weeks until disease progression or discontinuation due to unacceptable toxicity. 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% of nivolumab -treated and placebo-treated patients, respectively. The grade 3/4 TRAEs reported in more than two patients were diarrhea, fatigue, decreased appetite, and pyrexia, as well as increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in the nivolumab group, and fatigue and decreased appetite in the placebo group. The nivolumab and placebo-treated patients had similar rates of treatment-related adverse events leading to discontinuation, 2.7% and 2.5%, respectively.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.




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