FDA Grants Priority Review to Nivolumab Plus Ipilimumab to Treat NSCLC

The FDA recently granted priority review designation to Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) plus ipilimumab (Yervoy) as a first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), according to a Bristol Myers Squibb press release.

The nivolumab and ipilimumab will be administered in combination with limited chemotherapy for patients with MSCLC with no EGFR or ALK genomic tumor aberrations. The FDA set a PDUFA date of August 6, 2020 for the priority review, while also granting fast track designation to the combination.

“Despite treatment advances, there remains a serious unmet need for additional innovative treatment options for lung cancer patients globally,” Sabine Maier, MD, development lead, thoracic cancers, Bristol Myers Squibb, said in a press release. “The FDA’s acceptance and EMA’s validation of our applications represent important milestones for patients with lung cancer, and we look forward to working with regulatory authorities to bring the first and only dual immunotherapy plus limited chemotherapy regimen to patients as soon as possible.”

Moreover, the European Medicines Agency (EMA) validated a type 2 variation application for nivolumab plus ipilimumab in combination with chemotherapy for the same indication. This validation allows the EMA to begin the centralized review process.

These applications came on the heels of the results from the phase III CheckMate -9LA trial, which met its primary end point of superior overall survival. The open-label, multi-center, randomized trial evaluated the efficacy of nivolumab plus ipilimumab in combination with 2 cycles of chemotherapy, compared to chemotherapy alone as a first-line treatment for NSCLC.

Patients included in the experimental arm were treated for up to 2 years, while patients in the control arm were treated with up to 4 cycles of chemotherapy. The secondary endpoints of the trial included progression-free survival (PFS), overall response rate (ORR) and efficacy measures according to biomarkers.

Lung cancer is the leading cause of death in the United States, with NSCLC being the most common type of lung cancer, accounting for about 84% of all diagnoses. The 5-year survival rate for patients diagnosed with metastatic lung cancer is approximately 5%.

Reference:

Bristol Myers Squibb Announces Acceptance of U.S. and EU Regulatory Filings for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combined with Limited Chemotherapy in First-Line Lung Cancer [news release]. Princeton, New Jersey. Published April 8, 2020. https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-announces-acceptance-us-and-eu-regulatory. Accessed April 8, 2020.