Perioperative nivolumab plus platinum-based chemotherapy

Checkmate 77T (NCT04025879) was a phase III double-blind trial that enrolled 735 patients with resectable stage IIA (>4 cm) to IIIB (N2 node stage, single- or multistation) NSCLC. Patients had no EGFR variants or known ALK translocations. Patients were randomly assigned to receive either neoadjuvant nivolumab plus chemotherapy or neoadjuvant chemotherapy plus placebo every 3 weeks for four cycles, followed by surgery and adjuvant nivolumab or placebo every 4 weeks for 1 year. The primary end point was EFS according to blinded independent review. Secondary end points were pathological complete response and major pathological response according to blinded independent review, OS, and safety.[21]

Checkmate 77T (NCT04025879) was a phase III double-blind trial that enrolled 735 patients with resectable stage IIA (>4 cm) to IIIB (N2 node stage, single- or multistation) NSCLC. Patients had no EGFR variants or known ALK translocations. Patients were randomly assigned to receive either neoadjuvant nivolumab plus chemotherapy or neoadjuvant chemotherapy plus placebo every 3 weeks for four cycles, followed by surgery and adjuvant nivolumab or placebo every 4 weeks for 1 year. The primary end point was EFS according to blinded independent review. Secondary end points were pathological complete response and major pathological response according to blinded independent review, OS, and safety.[21]

At median follow-up of 25.4 months (range, 15.7–44.2), the 18-month EFS rate was 70.2% in the nivolumab group and 50.0% in the chemotherapy group (HRdisease progression or recurrence, abandoned surgery, or death, 0.58; 97.36% CI, 0.42–0.81; P < .001).[21][Level of evidence B1]

Checkmate 77T (NCT04025879) was a phase III double-blind trial that enrolled 735 patients with resectable stage IIA (>4 cm) to IIIB (N2 node stage, single- or multistation) NSCLC. Patients had no EGFR variants or known ALK translocations. Patients were randomly assigned to receive either neoadjuvant nivolumab plus chemotherapy or neoadjuvant chemotherapy plus placebo every 3 weeks for four cycles, followed by surgery and adjuvant nivolumab or placebo every 4 weeks for 1 year. The primary end point was EFS according to blinded independent review. Secondary end points were pathological complete response and major pathological response according to blinded independent review, OS, and safety.[21]

The pathological complete response rate was 25.3% in the nivolumab group and 4.7% in the chemotherapy group (OR, 6.64; 95% CI, 3.40–12.97).

Checkmate 77T (NCT04025879) was a phase III double-blind trial that enrolled 735 patients with resectable stage IIA (>4 cm) to IIIB (N2 node stage, single- or multistation) NSCLC. Patients had no EGFR variants or known ALK translocations. Patients were randomly assigned to receive either neoadjuvant nivolumab plus chemotherapy or neoadjuvant chemotherapy plus placebo every 3 weeks for four cycles, followed by surgery and adjuvant nivolumab or placebo every 4 weeks for 1 year. The primary end point was EFS according to blinded independent review. Secondary end points were pathological complete response and major pathological response according to blinded independent review, OS, and safety.[21]

The major pathological response rate (≤10% residual viable tumor cells after surgery in the primary tumor and sampled lymph nodes) was 35.4% in the nivolumab group and 12.1% in the chemotherapy group (OR, 4.01; 95% CI, 2.48–6.49).

Checkmate 77T (NCT04025879) was a phase III double-blind trial that enrolled 735 patients with resectable stage IIA (>4 cm) to IIIB (N2 node stage, single- or multistation) NSCLC. Patients had no EGFR variants or known ALK translocations. Patients were randomly assigned to receive either neoadjuvant nivolumab plus chemotherapy or neoadjuvant chemotherapy plus placebo every 3 weeks for four cycles, followed by surgery and adjuvant nivolumab or placebo every 4 weeks for 1 year. The primary end point was EFS according to blinded independent review. Secondary end points were pathological complete response and major pathological response according to blinded independent review, OS, and safety.[21]

Grade 3 or 4 treatment-related adverse events occurred in 32.5% of patients in the nivolumab group and 25.2% of patients in the chemotherapy group.