Source: https://pipelinereview.com/index.php/2020020273680/Antibodies/Bristol-Myers-Squibb-Withdraws-European-Application-of-Opdivo-nivolumab-Plus-Yervoy-ipilimumab-for-the-First-Line-Treatment-of-Advanced-Non-Small-Cell-Lung-Cancer.html
Timestamp: 2020-02-25 05:08:24
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Bristol-Myers Squibb Withdraws European Application of Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer | Antibodies | News Channels
Bristol-Myers Squibb Withdraws European Application of Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the First-Line Treatment of Advanced Non-Small Cell Lung Cancer
Published on Sunday, 02 February 2020 10:09
U.S. application for Opdivo and Yervoy in first-line NSCLC based on CheckMate -227 study under review with PDUFA date of May 15, 2020
Company committed to first-line lung cancer patients in Europe, U.S. and other markets with planned filing of results from CheckMate -9LA
PRINCETON, NJ, USA I January 31, 2020 IBristol-Myers Squibb Company (NYSE:BMY) today announced that the company has withdrawn its application in the European Union (EU) for the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for the treatment of advanced non-small cell lung cancer (NSCLC) based on data from CheckMate -227. 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.
CheckMate -227 is a multi-part open-label Phase 3 trial evaluating Opdivo-based regimens versus platinum-doublet chemotherapy in patients with first-line advanced NSCLC across non-squamous and squamous tumor histologies:
Part 1a: Opdivo plus Yervoy or Opdivo monotherapy versus chemotherapy in patients whose tumors express PD-L1
Part 1b: Opdivo plus Yervoy or Opdivo plus chemotherapy versus chemotherapy in patients whose tumors do not express PD-L1
There are two co-primary endpoints in Part 1 for Opdivo plus Yervoy (versus chemotherapy): overall survival (OS) in patients whose tumors express PD-L1 (assessed in patients enrolled in Part 1a) and progression-free survival (PFS) in patients with TMB ≥10 mut/Mb across the PD-L1 spectrum (assessed in patients enrolled across Parts 1a and 1b). Part 1 met both its co-primary endpoints of PFS with the Opdivo plus Yervoy combination versus chemotherapy in patients whose tumors have high (≥10 mutations/megabase, mut/mb) TMB, regardless of PD-L1 expression, and OS demonstrating a superior benefit for Opdivo plus Yervoy versus chemotherapy in first-line NSCLC patients whose tumors express PD-L1 ≥1%. Part 2 did not meet its primary endpoint for OS for Opdivo plus chemotherapy versus chemotherapy alone, in patients with non-squamous NSCLC.