Updated results from part 1 of the phase 3 CHECKMATE-227 trial with > 3 years of follow-up in patients with advanced non-small cell lung cancer (NSCLC) reported long-term efficacy data from first-line treatment with nivolumab and ipilimumab compared with platinum doublet chemotherapy.
Prof. Suresh Ramalingam (Winship Cancer Institute, Emory University, USA) gave the presentation this year at the Virtual ASCO.20 . CHECKMATE-227 had a total of 1,739 stage IV NSCLC patients enrolled; the co-primary endpoints were overall survival (OS) and progression-free survival (PFS). The trial met both endpoints, which were published last year in the New England J of Medicine . This presentation looked at the long-term benefits of this combination.
In part 1, the investigators randomized 1,189 patients whose tumors scored ≥ 1% for PD-L1 to 3 treatment arms: 3 mg/kg nivolumab every 2 weeks plus 1 mg/kg ipilimumab every 6 weeks (n = 396); 240 mg nivolumab every 2 weeks (n = 396); or histology-based chemotherapy (n = 397).
With a median follow-up of 43.1 months, patients with PD-L1 ≥ 1% had a 21% reduced risk for death when treated with nivolumab plus ipilimumab when compared with chemotherapy (median 17.1 months vs 14.9 months; HR: 0.79; 95% CI: 0.67–0.93). Nivolumab monotherapy was somewhat lower, granting a 10% reduced risk of death (HR: 0.90; 95% CI: 0.77-1.06). Patients in the nivolumab monotherapy arm had a median OS of 15.7 months (HR: 0.9; 95% CI, 0.77-1.06). OS rates at 3 years were 33% for nivolumab plus ipilimumab, 29% for nivolumab monotherapy, and 22% for platinum doublet chemotherapy.
Higher 3-year PFS rates with nivolumab plus ipilimumab versus chemotherapy (18% vs 4%) were also reported in patients with PD-L1 ≥ 1%.; the median PFS with nivolumab plus ipilimumab was 5.1 months (HR: 0.81; 95% CI: 0.69-0.96).
Overall response rates were also superior with nivolumab plus ipilimumab (36.4%), compared with nivolumab monotherapy (27.5%) and chemotherapy (30.2%) in patients with PD-L1 ≥ 1.
No new safety signals were observed in any of the arms with the extended follow-up.
- Ramalingam SS, et al. Nivolumab + ipilimumab versus platinum-doublet chemotherapy as first-line treatment for advanced non-small cell lung cancer: Three-year update from CheckMate 227 Part 1. ASCO Virtual Meeting, 29-31 May 2020, Abstract 9500.
- Hellmann MD, et al. Nivolumab plus Ipilimumab in Advanced Non-Small-Cell Lung Cancer. N Engl J Med. 2019;381(21):2020‐2031.