Bristol Myers Squibb’s Opdivo (nivolumab) plus Yervoy (ipilimumab) has received approval from the European Commission for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).
Opdivo plus Yervoy will now become available for NSCLC patients in the EU whose tumours have no sensitising epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation.
The combination of Opdivo plus Yervoy with two cycles of chemotherapy is the first dual immunotherapy-based treatment option to be approved for this disease in the EU, according to BMS.
The approval was based on results from BMS’ phase III CheckMate-9LA trial, wherein Opdivo plus Yervoy combined with two cycles of chemo reduced the risk of death by 31% compared to chemo alone.
The median progression-free survival with the combination treatment was 6.8 months compared to 5.0 months with chemo alone.
“This innovative regimen is built on the only approved dual immunotherapy foundation. The combination of Opdivo plus Yervoy has previously demonstrated long-term survival outcomes across multiple cancer types, including melanoma and renal cell carcinoma,” said Abderrahim Oukessou, vice president, thoracic cancers development lead at BMS.
“We look forward to collaborating with a broad range of European stakeholders to bring this unique combination of two potentially synergistic immunotherapies with chemotherapy to eligible patients with lung cancer,” he added.
The new NSCLC approval marks the third indication for an Opdivo plus Yervoy-based regimen in the EU, following prior approvals in metastatic melanoma and advanced renal cell carcinoma (RCC).