FDA backs BMS’ Opdivo/Yervoy in first-line NSCLC

Finally wins approval in market dominated by rival Keytruda

Bristol-Myers Squibb has finally gained approval from the US Food and Drug Administration for immunotherapy drug Opdivo in combination with low-dose CTLA4 inhibitor Yervoy for the treatment of first-line non-small cell lung cancer (NSCLC).

The FDA started a priority review of BMS’ PD-1 inhibitor Opdivo (nivolumab) in combination with Yervoy (ipilimumab) in previously untreated NSCLC patients, whose tumours don't have EGFR or ALK mutations, in January.

The approval was based on pivotal data from the CheckMate-9LA trial, which compared BMS’ immunotherapy combination treatment and two cycles of platinum-based chemotherapy to chemotherapy alone. Opdivo/Yervoy demonstrated an improved overall survival rate regardless of patients’ PD-L1 expression or tumour histology, with median overall survival reaching 14.1 months compared to 10.7 months on the chemotherapy arm.

“We have come a long way in understanding the role of dual immunotherapy-based approaches in cancer and the potential impact on patients’ long-term outcomes,” said David Carbone, CheckMate -9LA investigator and director of the James Thoracic Oncology Center at The Ohio State University.

“The positive findings from CheckMate-9LA demonstrate the benefit of combining dual immunotherapy with limited chemotherapy for NSCLC patients regardless of PD-L1 status. With today’s approval, more patients now have access to an Opdivo/Yervoy-based option and a chance at a longer life,” he added.

However, the path to approval in this indication has not been an easy one for BMS’ checkpoint inhibitor. In an initial study of Opdivo in NSCLC, the drug was unable to improve upon chemotherapy in the first-line setting.

BMS’ decision to combine Opdivo with Yervoy has allowed the company to carve a space within the NSCLC market, although it will face intense completion from Merck & Co/MSD’s rival checkpoint inhibitor Keytruda (pembrolizumab).

Keytruda is already widely prescribed by clinicians for newly-diagnosed NSCLC patients, as the drug has showed a clear benefit both as a monotherapy and in combination with chemotherapy.

Merck’s position in the NSCLC market has fostered immense growth, with sales of Keytruda skyrocketing since its approvals in the indication and a host of other cancer types.

BMS has enjoyed its own, if slightly more moderate, success for Opdivo/Yervoy following additional approvals in melanoma, renal cell carcinoma, hepatocellular carcinoma and colorectal cancer.