77T trial

Background

Randomized phase III CheckMate 77T trial, N=461, in stage IIA–IIIB resectable NSCLC. Patients were treatment-naive and eligible for surgical resection.

Interventions and follow up

Arm A: Nivolumab 360 mg IV Q3W + platinum-doublet chemotherapy Q3W for 4 cycles (neoadjuvant) → surgery → nivolumab 480 mg IV Q4W for 1 yr (adjuvant)
Arm B: Platinum-doublet chemotherapy Q3W + placebo Q3W for 4 cycles (neoadjuvant) → surgery → placebo Q4W for 1 yr (adjuvant)
Primary endpoint: EFS
mFollow up: 25.4 mo

Results

Definitive surgery: 77.7% vs 76.7%
R0 resection: 89.3% vs 90.4%
Adjuvant treatment administered: 62.0% vs 65.5%
Completed 1 yr of treatment: 37.1% vs 39.7%
EFS: not reached vs not reached (70.2% vs 50.0% at 18 mo), HR 0.58, 97.36% CI 0.42–0.81, P<.001
EFS PD-L1 ≥1%: HR 0.52, 95% CI 0.35–0.78
EFS PD-L1 <1%: HR 0.73, 95% CI 0.47–1.15
pCR: 25.3% vs 4.7%
MPR: 35.4% vs 12.1%

Adverse events

Overall: Grade 3–4 treatment-related AE 32.5% vs 25.2%
Endocrine: Hypothyroidism/thyroiditis 11.0% vs 1.7%

Conclusions

Perioperative nivolumab significantly improved EFS and pathological response vs chemotherapy alone in resectable NSCLC, without new safety concerns. Benefit was most pronounced in PD-L1 ≥1%; OS data remain immature.

Key Limitations

OS immature at this readout; benefit attenuated in PD-L1 <1% (HR 0.73, CI crosses 1); relative contributions of neoadjuvant vs adjuvant components not isolated.

Clinical Context

Perioperative nivolumab + chemotherapy is FDA approved for resectable NSCLC, supporting perioperative chemoimmunotherapy as standard per ASCO/ESMO, particularly in PD-L1 ≥1% tumors.

References