The drug maker is seeking approval for use of the combination – the first combining two immune-oncology agents to be filed with regulator for lung cancer – in patients with a tumor mutational burden (TMB) of ≥10 mutations per megabase (mut/Mb).
TMB is a quantitative biomarker that reflects the total number of mutations carried by tumor cells. Cells with high TMB have higher levels of neoantigens, which are thought to help the immune system recognise tumors and incite an increase in cancer-fighting T cells and an anti-tumor response. Thus TMB could help predict the likelihood a patient responds to immunotherapies, the firm noted.
According to recently released data from the CheckMate-227 trial, the Opdivo (nivolumab)/Yervoy (ipilimumab) combo slashed the risk of progression or death by 42 percent versus chemotherapy in first-line advanced NSCLC cancer patients whose tumours have high TMB.
“Lung cancer is a complex disease, and we believe multiple treatment approaches, including those that are biomarker-driven, are needed to help individual patients,” said Sabine Maier, development lead, thoracic cancers, B-MS. “We look forward to working with the FDA throughout the review process to bring this important treatment option to patients.”
A decision by the FDA on the application is expected by February 20 next year.
US regulators cleared a combination of Opdivo and Yervoy as a first-line treatment for patients with advanced renal cell carcinoma in April, and the duo is also approved to treat skin cancer.