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European Commission approves Bristol Myers’ Opdivo plus chemotherapy to treat HER2 negative, advanced or metastatic GEJ or EAC

Princeton
Friday, October 22, 2021, 10:00 Hrs  [IST]

Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC) whose tumors express PD-L1 with a combined positive score (CPS) = 5.

The EC’s decision is based on results from the phase 3 CheckMate -649 trial, in which first-line treatment with Opdivo plus leucovorin, 5-fluorouracil and oxaliplatin (Folfox) or capecitabine and oxaliplatin (CapeOX) was compared with chemotherapy alone. Results from the trial showed a statistically significant and clinically meaningful improvement in overall survival (OS) and progression-free survival (PFS) in patients with unresectable advanced or metastatic gastric cancer (GC), GEJ cancer (GEJC) or EAC whose tumors express PD-L1 with a CPS = 5 (the primary endpoints of the study). The statistically significant OS benefit shown with Opdivo plus chemotherapy was also observed in PD-L1 positive patients with CPS = 1 and in the all-randomized population. The safety profile observed for Opdivo plus chemotherapy in the CheckMate -649 trial was consistent with the known safety profiles of the individual treatments.

“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, M.D., development lead, gastrointestinal cancers, Bristol Myers Squibb. “With limited advances for HER2-negative gastric cancers made in the past ten years, we are especially pleased to move the field forward and introduce this Opdivo-based combination for patients in the European Union.”

The EC approval allows for the use of Opdivo in combination with fluoropyrimidine and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric cancer, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC), whose tumors express PD-L1 with a combined positive score (CPS) = 5 in the 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway.

CheckMate -649 is a phase 3 randomized, multi-center, open-label study evaluating Opdivo plus chemotherapy or the Opdivo plus Yervoy combination compared to chemotherapy alone in patients with previously untreated, non-HER2-positive, advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma. Patients in the Opdivo plus chemotherapy arm received Opdivo 360 mg plus capecitabine and oxaliplatin (CapeOX) every three weeks or Opdivo 240 mg plus 5-fluorouracil, leucovorin and oxaliplatin (Folfox) every two weeks. Patients in the Opdivo plus Yervoy arm received Opdivo 1 mg/kg plus Yervoy 3 mg/kg every three weeks for four cycles followed by Opdivo 240 mg every two weeks. Patients in the chemotherapy arm received FOLFOX or CapeOX every two or three weeks, respectively. All patients continued treatment for two years or until disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoints of the trial are overall survival (OS) in PD-L1 positive patients with a combined positive score (CPS) = 5 treated with Opdivo plus chemotherapy and PFS, as assessed by Blinded Independent Central Review (BICR), in CPS = 5 patients treated with Opdivo plus chemotherapy compared to chemotherapy alone. Secondary endpoints include OS in CPS = 1 and all randomized patients treated with Opdivo plus chemotherapy as well as OS and time to symptom deterioration (TTSD) in patients treated with Opdivo plus Yervoy compared to chemotherapy alone.

 

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