FDA Approves Opdivo + Chemotherapy as Neoadjuvant Treatment for Lung Cancer

On March 4, 2022, the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) in combination with platinum-doublet chemotherapy as neoadjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC). This represents the first FDA approval for neoadjuvant therapy for patients with early-stage resectable NSCLC.

The approval was based on the CheckMate-816 trial, which evaluated patients with resectable NSCLC (Stage IB [≥4cm], II, or IIIA) and measurable disease. In this randomized, open-label trial, 358 patients, regardless of PD-L1 expression, were randomized to receive either Opdivo + platinum-doublet chemotherapy (every 3 weeks for 3 cycles) or chemotherapy alone (every 3 weeks for 3 cycles).

The primary endpoints were event-free survival (EFS) and pathological complete response (pCR). The median EFS was 31.6 months in the Opdivo + chemotherapy group compared to 20.8 months in the chemotherapy group. The pCR rate was 24% in the Opdivo + chemotherapy group versus 2.2% in the chemotherapy group.

The most common adverse events (incidence ≥20%) were nausea, constipation, fatigue, decreased appetite, and rash. The addition of Opdivo to chemotherapy did not delay or prevent surgery. The median length of hospital stay after surgery and the incidence of postoperative complications were similar between the two groups.

The recommended dosage for Opdivo is 360 mg, administered on the same day as platinum-doublet chemotherapy every 3 weeks for 3 cycles.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvant-nivolumab-and-platinum-doublet-chemotherapy-early-stage-non-small-cell-lung

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