A 2-year update of the CheckMate 9LA trial shows sustained benefit of first-line treatment with nivolumab plus ipilimumab plus 2 cycles of chemotherapy versus chemotherapy alone in patients with advanced non-small cell lung cancer (NSCLC). The combination of nivolumab and ipilimumab, which have distinct but complementary mechanisms of action, has shown improved long-term overall survival benefit in advanced NSCLC . In the randomized, phase 3 CheckMate 9LA trial (NCT03215706), first-line nivolumab plus ipilimumab combined with 2 cycles of chemotherapy significantly improved overall survival, progression-free survival, and objective response rate versus chemotherapy alone (4 cycles) . Clinical benefit was observed regardless of PD-L1 expression level and histology. This regiment is now approved in the USA and Europe, amongst others, as first-line treatment for adult patients with metastatic NSCLC and no EGFR or ALK genomic tumor aberrations.
Prof. Martin Reck (Lung Clinic Grosshansdorf, Germany) presented data with 2-year minimum follow-up from the CheckMate 9LA study as well as a post-hoc efficacy analysis in patients who discontinued nivolumab/ipilimumab/chemotherapy due to treatment-related adverse events . At a minimum follow-up of 24.4 months (median 30.7 months) for overall survival, patients treated with nivolumab/ipilimumab/chemotherapy continued to derive overall survival benefit versus chemotherapy alone, with a median overall survival of 15.8 months versus 11.0 months, respectively; 2-year overall survival rates were 38% versus 26%. Median progression-free survival with nivolumab/ipilimumab/chemotherapy was 6.7 months versus 5.3 months with chemotherapy.
Similar clinical benefit with nivolumab/ipilimumab/chemotherapy versus chemotherapy was observed in all randomized patients and across the majority of subgroups, regardless of PD-L1 expression and/or histology. Any grade and grade 3–4 treatment-related adverse events were reported in 92% and 48% of patients in the nivolumab/ipilimumab/chemotherapy arm versus 88% and 38% in the chemotherapy-alone arm, respectively. In patients who discontinued nivolumab/ipilimumab/chemotherapy due to treatment-related adverse events, median overall survival was 27.5 months (2-year overall survival rate 54%).
“These updated results from Checkmate 9LA continue to support nivolumab/ipilimumab plus 2 cycles of chemotherapy as an efficacious first-line treatment option for patients with advanced NSCLC. In addition, discontinuation due to treatment-related adverse events does not have an negative impact on the long-term benefits seen of this combination,” concluded Prof. Reck.
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- Reck M, et al. First-line nivolumab (NIVO) plus ipilimumab (IPI) plus two cycles of chemotherapy (chemo) versus chemo alone (4 cycles) in patients with advanced non-small cell lung cancer (NSCLC): Two-year update from CheckMate 9LA. ASCO 2021 Virtual Meeting, abstract 9000.