CheckMate 77T
Perioperative Nivolumab in Resectable Lung Cancer
Design:
- A phase 3, randomized, placebo-controlled, double-blind trial
Objective:
- To assess the effect of perioperative treatment (i.e., neoadjuvant therapy followed by surgery and adjuvant therapy) with nivolumab on improving outcomes in patients with resectable non-small-cell lung cancer (NSCLC).
Patients:
- 461 patients
Inclusion criteria:
- Age 19-80 years
- Implantation of BP-SES for ACS
Exclusion criteria:
- Increased bleeding risk (e.g., prior intracranial hemorrhage, Hb<8 g/dL, platelets <100,000/mL)
- Need for oral anticoagulation
- Current or anticipated pregnancy
- Life expectancy <1 year
Comparison:
- Perioperative Nivolumab + Chemotherapy (n = 229)
- Versus
- Perioperative Placebo + Chemotherapy (n = 232)
Primary Outcome:
- Event-free survival %
- Nivolumab: 70.2%
- Placebo: 50.0%
- HR: 0.58, 97.36% CI: 0.42 to 0.81 (P < 0.001)
Secondary Outcomes:
- Pathological complete response %
- Nivolumab: 25.3%
- Placebo: 4.7%
- OR: 6.64, 95% CI: 3.40 to 12.97
- Major pathological response %
- Nivolumab: 35.4%
- Placebo: 12.1%
- OR: 4.01, 95% CI: 2.48 to 6.49
Conclusion:
- In adults with resectable stage IIA to IIIB NSCLC, perioperative nivolumab significantly improved event-free survival at 18 months compared to chemotherapy alone.
Reference:
- Cascone T et al. N Engl J Med 2024;390:1756-1769
This data highlights the key points of the CheckMate 77T trial, comparing the outcomes of perioperative nivolumab combined with chemotherapy versus chemotherapy alone in patients with resectable non-small-cell lung cancer.