The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2021.
The filing was based on results from the pivotal Phase 3 CheckMate -649 trial, which showed that first-line treatment with Opdivo plus leucovorin, 5-fluorouracil and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) led to a statistically significant improvement in overall survival and progression-free survival for patients with unresectable advanced or metastatic gastric cancer, GEJC or EAC whose tumors express PD-L1 with a combined positive score ≥ 5, compared to treatment with chemotherapy alone.
A statistically significant OS benefit was also observed in the all-randomized population. The safety profile of Opdivo plus chemotherapy was consistent with the known safety profile of the individual treatments.
To date, CheckMate -649 is the largest randomized, global Phase 3 study of an immune checkpoint inhibitor-based therapy for patients with gastric cancer, GEJC and EAC.
Bristol Myers Squibb thanks the patients and investigators who were involved in the CheckMate -649 clinical trial.
CheckMate -649 is a Phase 3 randomized, multi-center, open-label study evaluating Opdivo plus chemotherapy or the Opdivo plus Yervoy (ipilimumab) combination compared to chemotherapy alone in patients with previously untreated, non-HER2-positive, advanced or metastatic gastric or GEJ cancer or esophageal adenocarcinoma.
The primary endpoints of the trial are OS in PD-L1 positive patients with a combined positive score ≥ 5 treated with Opdivo plus chemotherapy and PFS, as assessed by Blinded Independent Central Review, in CPS ≥ 5 patients treated with Opdivo plus chemotherapy compared to chemotherapy alone.
Key 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 in patients treated with Opdivo plus Yervoy compared to chemotherapy alone.
Patients in the Opdivo plus chemotherapy arm received Opdivo 240 mg plus leucovorin, 5-fluorouracil, and oxaliplatin (FOLFOX) every two weeks or Opdivo 360 mg plus capecitabine and oxaliplatin (CapeOX) every three 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 up to two years or until disease progression, unacceptable toxicity or withdrawal of consent.
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