Japan approves Opdivo, the first-ever immuno-oncology agent for unresectable advanced/recurrent gast

Bristol-Myers Squibb Company (BMY) has announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Opdivo (nivolumab) for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy. This approval was based on the Phase 3 study ATTRACTION-2 (ONO-4538-12), in which Opdivo significantly reduced patients’ risk of death by 37% (HR 0.63 [95% CI: 0.51-0.78, p<0.0001]) when compared to a placebo.

"The approval of Opdivo for advanced or recurrent gastric cancer in Japan offers healthcare 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. "Opdivo has now been approved for six indications in Japan, underscoring the success of the Ono Pharmaceutical and Bristol-Myers Squibb partnership and our shared commitment to delivering innovative medicines to patients and advancing cancer care in Japan and around the world."

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, M.D., 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 Opdivo, which has shown in clinical trials to improve survival across all patient types, including those whose tumors express PD-L1."

About ATTRACTION-2 (ONO-4538-12)

The approval is based on the results of ATTRACTION-2 (ONO-4538-12), a Phase 3 randomized, double-blind, placebo-controlled clinical trial conducted in Japan, South Korea and Taiwan, China, evaluating the efficacy and safety of Opdivo in 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. This study was conducted by Ono Pharmaceutical Co. Ltd. of Japan, and data is currently in press with The Lancet.

The ATTRACTION-2 (ONO-4538-12) study evaluated the efficacy of Opdivo 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, Opdivo 3 mg/kg or placebo was administered every two weeks until disease progression or discontinuation due to unacceptable toxicity. The safety profile of Opdivo was consistent with previously reported studies in solid tumors. TRAEs of any grade and grade 3/4 occurred in 42.7% versus 26.7% and 10.3% versus 4.3% of Opdivo-treated and placebo-treated patients, respectively. The grade 3/4 TRAEs reported in more than two patients were diarrhea, fatigue, decreased appetite, pyrexia, as well as increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in the Opdivo group, and fatigue and decreased appetite in the placebo group. The Opdivo and placebo-treated patients had similar rates of TRAEs leading to discontinuation, 2.7% and 2.5%, respectively.