The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) plus ipilimumab (Yervoy) for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.
The sBLA was based on data from the open-label, multicenter, randomized phase 3 CheckMate -9LA trial that compared the efficacy of nivolumab plus ipilimumab in combination with chemotherapy to chemotherapy alone as a first-line treatment in patients with metastatic NSCLC regardless of PD-L1 expression and histology. Patients were randomized to receive nivolumab plus ipilimumab for up to 2 years or until disease progression or unacceptable toxicity, or chemotherapy alone for up to 4 cycles followed by optional maintenance therapy until disease progression or unacceptable toxicity.
Results demonstrated that nivolumab plus ipilimumab met the primary end point of superior overall survival at a prespecified interim analysis vs chemotherapy alone. Full study results will be presented at an upcoming congress.
A Prescription Drug User Fee Act (PDUFA) target date of August 6, 2020 has been set for this application.
“Despite treatment advances, there remains a serious unmet need for additional innovative treatment options for lung cancer patients globally,” said Sabine Maier, MD, development lead, thoracic cancers, Bristol Myers Squibb. “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.”
Opdivo plus Yervoy is already indicated for the treatment of unresectable or metastatic melanoma; for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma; for the treatment of microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer (CRC); and for the treatment of hepatocellular carcinoma (HCC) in patients previously treated with sorafenib.
This article originally appeared on MPR