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EMA Accepts Bristol Myers Squibb's Submission for Opdivo in Gastroesophageal Cancers

NEW YORK – Bristol Myers Squibb said on Monday that the European Medicines Agency has accepted its marketing authorization application for nivolumab (Opdivo) with chemotherapy as a first-line treatment for patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.

The EMA will now begin its centralized review of BMS's submission, which includes data from the Phase III CheckMate-649 trial. In the study, gastric and esophageal cancer patients received either nivolumab plus chemotherapy (leucovorin, 5-fluorouracil and oxaliplatin or capecitabine and oxaliplatin) versus chemotherapy alone. The study's primary endpoints were overall survival and progression-free survival specifically in patients whose tumors had a PD-L1 combined positive score (CPS) of 5 or higher. As secondary endpoints, researchers also looked at the impact of nivolumab and chemotherapy on overall survival and progression-free survival in the entire study population.

Researchers previously presented data from CheckMate-649 at the European Society for Medical Oncology's Virtual Congress in September and reported that patients whose tumors had a PD-L1 CPS of at least 5 lived an average of 14.4 months on nivolumab plus chemo compared to 11.1 months for those on chemo alone. In the overall population, patients who received nivolumab plus chemotherapy experienced a median overall survival of 13.8 months versus 11.6 months among patients who received chemotherapy alone.

During ESMO, experts questioned whether the improved survival outcomes seen in the all-comer population were being driven by those with high PD-L1-expressing tumors. In a statement, BMS said that in CheckMate-649, the statistically significant overall survival benefit with nivolumab plus chemotherapy was also seen in PD-L1 positive patients with lower PD-L1 expression (i.e. CPS at least 1).

"Gastric cancer is among the top three causes of cancer death globally, and a large proportion of metastatic gastric and esophageal cancer patients do not live beyond one year after diagnosis," Ian Waxman, development lead for gastrointestinal cancers at BMS, said in a statement. "Today's validation by the EMA marks a crucial step toward advancing treatment options and helping to improve outcomes for people living with these cancers."

Based on the CheckMate-649 data, BMS is hoping to advance nivolumab as a first-line option for advanced gastric and esophageal cancer patients. The drug is already available in the US as a later-line option for recurrent esophageal cancer, and the EMA issued a positive opinion for this same indication last year.