The application was originally filed in 2018 for patients with first-line NSCLC who have tumor mutational burden ≥10 mutations/megabase, based on the final analysis of progression-free survival, a co-primary endpoint in the trial. The application was subsequently amended to include the statistically significant result of overall survival, a co-primary endpoint, from CheckMate -227 Part 1a evaluating Opdivo plus Yervoy versus chemotherapy in patients whose tumors expressed PD-L1 ≥1%.
Though the Committee for Medicinal Products for Human Use (CHMP) acknowledged the integrity of the patient level data, the CHMP determined a full assessment of the application was not possible following multiple protocol changes the company made in response to rapidly evolving science and data. The company has no plans to refile this application in the EU.
“CheckMate -227 is a robust Phase 3 study of more than 1,700 patients. Opdivo plus Yervoy demonstrated a statistically and clinically significant overall survival benefit compared to chemotherapy for patients with first-line NSCLC. The durable survival benefit seen in CheckMate -227 is an important result for patients and we are disappointed with the CHMP’s position,” said Samit Hirawat, M.D., Chief Medical Officer, Bristol-Myers Squibb.
In January 2020, the U.S. Food and Drug Administration granted a Priority Review for the combination of Opdivo and Yervoy for the treatment of first-line NSCLC based on data from Part 1 of the Phase 3 CheckMate -227 trial.
Additionally, the company plans to file applications in the U.S., Europe and other markets following the positive interim results of CheckMate -9LA for the combination of Opdivo plus Yervoy administered concomitantly with a limited course of chemotherapy for the first-line treatment of NSCLC. The results from CheckMate -227 and CheckMate -9LA build on the established benefit the combination of Opdivo plus Yervoy has previously shown in first-line melanoma and renal cell carcinoma.
“Patients with lung cancer should have access to innovative new therapies that offer the promise of long-term overall survival. We are continuing to advance our application in the U.S. for CheckMate -227 and plan to file data from CheckMate -9LA in markets globally to help address the serious unmet need in first-line lung cancer,” said Hirawat.
Source: Company Press Release