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BMS's Opdivo, Yervoy Plus Chemo Gets Positive CHMP Opinion in NSCLC Regardless of PD-L1 Status

NEW YORK – Bristol Myers Squibb on Friday announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive recommendation for two of its immune checkpoint inhibitors, nivolumab (Opdivo) and ipilimumab (Yervoy), in combination with platinum-based chemotherapy as a first-line treatment for metastatic non-small cell lung cancer patients whose tumors lack EGFR mutations or ALK translocations.

Following CHMP's recommendation, the European Commission will review the opinion and decide whether to approve the regimen.

The positive opinion follows the results of the CheckMate 9LA trial, presented during the 2020 American Society of Clinical Oncology annual virtual meeting in May. The US Food and Drug Administration approved the combination based on data from this trial, as did regulators in other countries.

The study demonstrated that the addition of the checkpoint inhibitors to platinum-based chemotherapy led to superior overall survival versus chemotherapy alone. Specifically, the median overall survival for patients receiving the combination therapy was 14.1 months compared to 10.7 months for those receiving the chemotherapy alone. In a follow-up analysis performed after 12.7 months, patients on the immunotherapy combination demonstrated a median overall survival benefit of 15.6 months versus 10.9 months in the chemotherapy arm.

Because the indication does not stipulate that patients' tumors meet a certain threshold of PD-L1 expression, BMS has highlighted that its approval expands subgroups of patients eligible to receive the PD-1 and CTLA-4 inhibitors. A previous FDA approval for first-line, chemo-free nivolumab and ipilumumab in early May, on the other hand, required that patients' tumors express PD-L1 in 1 percent or more of their tumor cells.

"This positive CHMP opinion reflects the potential for Opdivo plus Yervoy with two cycles of chemotherapy to offer the chance for a longer life to patients across subgroups of metastatic NSCLC, a devastating cancer where unmet needs still exist," Abderrahim Oukessou, VP and thoracic cancers development lead at BMS, said in a statement. "We look forward to the EC's decision and hope to soon introduce this innovative, dual immunotherapy approach to patients across the EU who may benefit."