Sustained efficacy of nivolumab/ipilimumab plus 2 cycles of chemotherapy in NSCLC

A 2-year update of the CheckMate 9LA trial showed a 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 [1]. In the randomised, 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 4 cycles of chemotherapy alone [2]. Clinical benefit was observed regardless of PD-L1 expression level and histology. This regimen is now approved in the USA and Europe, among others, as first-line treatment for adult patients with metastatic NSCLC and no EGFR or ALK genomic tumour aberrations. Prof. Martin Reck (Lung Clinic Grosshansdorf, Germany) presented updated data with a 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 [3].

At a median follow-up of 30.7 months, patients treated with nivolumab/ipilimumab/chemotherapy continued to derive overall survival benefit compared with 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% (see Figure). The median progression-free survival with nivolumab/ipilimumab/chemotherapy was 6.7 months versus 5.3 months with chemotherapy. A similar clinical benefit was observed in all randomised patients and across the majority of subgroups, regardless of PD-L1 expression and/or histology.

Figure: Updated overall survival in all randomised patients from CheckMate 9LA [3]



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 arm, respectively. In patients who discontinued nivolumab/ipilimumab/chemotherapy due to treatment-related adverse events, the 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 a negative impact on the long-term benefits seen with this combination,” concluded Prof. Reck.

1. 
   
   1. Ramalingam SS, et al. J Clin Oncol. 2020;38(supl15);abstract 9500.
   2. Paz-Ares L, et al. Lancet Oncol. 2021;22:198-21.
   3. 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. Abstract 9000, ASCO 2021 Virtual Meeting, 4–8 June.

 

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Posted on 12 August 202115 February 2024