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The EC approved BMS’s Opdivo (nivolumab) as a complementary treatment to chemotherapy for adult patients with certain types of gastric or esophageal cancer.
Bristol Myers Squibb (BMS) announced on Oct. 21, 2021, that the European Commission (EC) approved its drug Opdivo (nivolumab) as a complementary treatment to fluoropyrimidine- and platinum-based combination chemotherapy in adult patients with certain types of gastric or esophageal cancer. Nivolumab is a programmed death-1 immune checkpoint inhibitor that is designed to use one’s immune system to help restore the anti-tumor immune response.
According to a company press release, EC’s decision was made following a Phase III trial that evaluated nivolumab. The study found a clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) in patients given nivolumab who had unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. These results were found in patients whose tumors expressed a combined positive score greater than or equal to five.
The study evaluated OS and PFS rates among patients who received nivolumab and chemotherapy relative to patients who received only chemotherapy. According to BMS, median OS was 14.4 months in patients receiving nivolumab vs. 11.1 months in those receiving chemotherapy alone, while median PFS was 8.31 months in patients receiving nivolumab vs. 6.05 months chemotherapy alone.
“This approval marks a great achievement for many patients with gastric, gastroesophageal junction, and esophageal adenocarcinomas, who now have a new treatment option that has demonstrated superior overall survival compared to the long-standing standard of care,” said Ian M. Waxman, development lead, Gastrointestinal Cancers, BMS, in the press release. “With limited advances for [human epidermal growth factor receptor 2]-negative gastric cancers made in the past 10 years, we are especially pleased to move the field forward and introduce this [nivolumab]-based combination for patients in the European Union.”
Source: Bristol Myers Squibb