NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended Bristol Myers Squibb's checkpoint inhibitor Opdivo (nivolumab) plus chemotherapy as a neoadjuvant treatment for certain PD-L1-positive non-small cell lung cancer patients.
The recommendation — which specifies patients must express PD-L1 in at least 1 percent of tumor cells — is based on the results of the Phase III CheckMate-816 trial, in which pre-surgery Opdivo plus chemotherapy improved stage IB to IIIA NSCLC patients' event-free survival outcomes and complete response rates versus chemo alone. BMS is still tracking patients' overall survival and other endpoints in the study as well as outcomes in patient subgroups.
In contrast to the CHMP recommendation, the US Food and Drug Administration has approved the Opdivo-chemo combination as a neoadjuvant treatment for NSCLC patients regardless of PD-L1 expression status.
If the European Commission takes CHMP's recommendation and approves the treatment combination, Opdivo plus chemo will be the first neoadjuvant immunotherapy-containing treatment regimen available to NSCLC patients in Europe.