A phase clinical trial evaluating the efficacy and safety of nivolumab (marketed as Opdivo by Bristol Meyers-Squibb) in patients with unresectable advanced or recurrent gastric cancer refractory to, or intolerant of, standard therapy, met its primary endpoint of overall survival.

Gastric cancer, also known as stomach cancer, is the fifth most common malignancy in the world, with more than 950,000 patients diagnosed each year, and is the third leading cause of cancer-related death, with more than 720,000 deaths reported annually.

Gastric cancer is more common in men than in women, and the average age at diagnosis is 69 years.

While the five-year survival rate for people with gastric cancer is 30.4%, this rate falls to 5% for those whose gastric cancer has metastasised.

Though chemotherapy has been offering some activity in tumour shrinkage as a treatment for unresectable advanced or recurrent gastric cancer, there remains an important unmet medical need in this setting.

ONO-4538-12 is a multicenter, double-blind, randomised, placebo-controlled, Phase 3 clinical trial conducted in Japan, Korea and Taiwan, aiming to evaluate the efficacy and safety of nivolumab in patients with unresectable advanced or recurrent gastric cancer, including gastroesophageal junction cancer, refractory to, or intolerant of, standard therapy.

In this study, nivolumab 3 mg/kg or placebo was administered every two weeks until disease progression or discontinuation due to unacceptable toxicity.

The primary endpoint, overall survival, was assessed for the superiority of nivolumab versus placebo.

Fouad Namouni, M.D., head of development, Oncology, Bristol-Myers Squibb, commented, “Patients with advanced or recurrent gastric cancer generally have a poor prognosis, and there are currently no standard-of-care treatment options for patients who fail to respond to or who are intolerant of standard chemotherapy. With the results from the ONO-4538-12 study, nivolumab is now the first immuno-oncology agent to demonstrate a survival benefit for this patient population.”

Ono Pharmaceutical Co. Ltd. of Japan, Bristol-Myers Squibb’s development partner for nivolumab, conducted the ONO-4538-12 trial. 

The companies will work with investigators on the future presentation of the study results.

Source: BusinessWire