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European Commission Approves Opdivo, Yervoy, Chemo as First-Line NSCLC Treatment

NEW YORK – Bristol Myers Squibb announced on Friday that the European Commission approved the combination of its immune checkpoint inhibitors, nivolumab (Opdivo) and ipilimumab (Yervoy), with chemotherapy as a first-line treatment for non-small cell lung cancer patients.

The combination treatment was approved for metastatic NSCLC patients without EGFR or ALK gene mutations and regardless of their PD-L1 status.

The EC based its decision on the Phase III CheckMate-9LA trial, which compared the combination of nivolumab, ipilimumab, and two cycles of chemotherapy against chemotherapy alone. Patients' overall response rate on the nivolumab-ipilimumab combination was 38 percent, compared to 25 percent on chemotherapy alone. In the study, the median progression-free survival was 6.8 months compared to 5 months with chemotherapy alone. The combination treatment also reduced the risk of death by 31 percent.

"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," Abderrahim Oukessou, thoracic cancers development lead at Bristol Myers Squibb, said in a statement. "The combination of Opdivo plus Yervoy has previously demonstrated long-term survival outcomes across multiple cancer types, including melanoma and renal cell carcinoma."

The combination treatment was approved for a similar NSCLC indication by the US Food and Drug Administration in May. The combination of nivolumab and ipilimumab is also approved in the EU for melanoma and renal cell carcinoma.