NEW YORK – The European Commission on Thursday approved Bristol Myers Squibb's checkpoint inhibitor Opdivo (nivolumab) plus chemotherapy as neoadjuvant treatment for PD-L1-positive non-small cell lung cancer patients.
Patients must be at a high risk for disease recurrence and express PD-L1 in at least 1 percent of tumor cells. The regulators based the approval on the results of the Phase III CheckMate-816 trial, in which patients who received neoadjuvant Opdivo plus chemotherapy lived longer without their cancer progressing than patients who received neoadjuvant chemotherapy alone. Patients also experienced a pathologic complete response improvement with the combination versus chemotherapy alone.
The approval follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) last month and marks the availability of the first neoadjuvant immunotherapy-based treatment for NSCLC patients in the EU.
The US Food and Drug Administration has also approved this Opdivo-chemo combination in the neoadjuvant NSCLC setting, but the indication is not restricted based on PD-L1 status. The same is true across 20 other countries in which this combination is approved including Japan and China.
With the EC's approval, the combined treatment is now an option for eligible patients in 27 EU member states as well as in Iceland, Liechtenstein, and Norway.