Phase 3 trial of nivolumab plus ipilimumab plus chemotherapy for mNSCLC: four-year follow-up of CheckMate 9LA

Primary analysis of the multinational phase 3 CheckMate 9LA trial found that nivolumab plus ipilimumab plus chemotherapy (experimental group) prolonged overall survival versus chemotherapy alone (control group). Four-year follow-up of the trial has now been published. The figure shows that OS was longer in the experimental group compared with the control group among all randomized patients (A), patients with PD-L1 expression <1% (B), patients with PD-L1 expression ≥ 1% (C), patients with squamous histology (D), and patients with nonsquamous histology (E). Among patients who discontinued all components of nivolumab plus ipilimumab with chemotherapy due to treatment-related adverse events (17% of patients), the 4-year OS rate was 41%. With treatment-switching adjustment for the 36% of patients receiving subsequent immunotherapy in chemotherapy arm, the OS-HR of nivolumab plus ipilimumab plus chemotherapy versus chemotherapy was 0.66 (95% CI 0.55-0.80). No new safety signals were observed. The authors conclude that in this 4-year update, patients treated with nivolumab plus ipilimumab and chemotherapy continued to have long-term , durable efficacy benefit over chemotherapy, regardless of tumor PD-L1 expression and/or histology.