BMS’ Opdivo plus Yervoy combo gets EC approval for metastatic NSCLC

Bristol Myers Squibb (BMS) has secured approval from the European Commission (EC) for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC).

The approval is for the Opdivo/Yervoy combination to be used with two cycles of platinum-based chemotherapy in adult patients, whose tumors have no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation.

According to Bristol Myers Squibb, the Opdivo plus Yervoy combination with two cycles of chemotherapy is now the first dual immunotherapy-based treatment option to be approved in the European Union (EU) for patients with this disease.

The approval from the European Commission has been driven by the findings of the phase 3 CheckMate -9LA trial, which met its primary endpoint of superior overall survival (OS). The late-stage trial also met its secondary endpoints of progression-free survival (PFS) and overall response rate (ORR).

The Opdivo plus Yervoy combination administered concomitantly with two cycles of chemotherapy was compared to chemotherapy alone in the phase 3 clinical trial.

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Abderrahim Oukessou – Bristol Myers Squibb vice president, thoracic cancers development lead, said: “The European Commission’s approval of Opdivo plus Yervoy with two cycles of chemotherapy is an important milestone for patients with metastatic non-small cell lung cancer who face a difficult prognosis despite recent advances.

“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.

“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.”

The latest approval from the European Commission marks the third indication for an Opdivo plus Yervoy-based regimen having previously been approved for the treatment of metastatic melanoma and advanced renal cell carcinoma (RCC).

Last month, Bristol Myers Squibb secured approval for the Opdivo and Yervoy combination from the US Food and Drug Administration (FDA) for the first-line treatment of unresectable malignant pleural mesothelioma (MPM) in adults.