On March 4, 2022, the FDA approved a new indication for the PD-1 inhibitor (a type of immunotherapy) Opdivo (nivolumab; from Bristol Myers Squibb), in combination with platinum-doublet chemotherapy, for the neoadjuvant (first-line) treatment of adults with early-stage non–small-cell lung cancer (NSCLC). This represents the first FDA approval of neoadjuvant therapy for patients with early-stage NSCLC.
This approval was based on the results of the CheckMate-816 study, a randomized, open-label clinical trial of patients with early-stage, including stage IB, stage II, or stage IIIA NSCLC. Patients were enrolled regardless of their tumor PD-1 or PD-L1 status. A total of 358 patients were randomized to Opdivo plus platinum-based chemotherapy or to platinum-chemotherapy alone, administered every 3 weeks for up to 3 cycles in each group.
The average median event-free survival was 31.6 months with Opdivo plus chemotherapy and 20.8 months with chemotherapy alone. The pathologic complete response rate was 24% with Opdivo plus chemotherapy versus 2.2% with chemotherapy alone.
The most common side effects with Opdivo plus chemotherapy were nausea, constipation, fatigue, decreased appetite, and rash. The addition of immunotherapy (Opdivo) to chemotherapy did not lead to more delays or cancellations of surgery.
