Relatlimab addition benefits only a subgroup of metastatic NSCLC

The addition of relatlimab to first-line nivolumab plus platinum-doublet chemotherapy benefitted only a small subgroup of patients with metastatic non-small cell lung cancer (NSCLC) in the phase 2 RELATIVITY-104 trial.

Relatlimab is a LAG-3-blocking antibody that restores effector T-cell function and is already approved for the treatment of advanced melanoma (in combination with nivolumab) [1]. The phase 2 RELATIVITY-104 trial (NCT04623775) evaluates the effectiveness of adding relatlimab to nivolumab plus platinum-doublet chemotherapy as a first-line treatment in patients with metastatic NSCLC.

The study randomised 309 participants with previously untreated stage IV/recurrent NSCLC 1:1 to receive relatlimab/nivolumab/chemotherapy or placebo/nivolumab/chemotherapy [2]. The primary endpoint was objective response rate (ORR). The results were presented by Prof. Nicolas Girard (Institut Curie, France) [2].

After a median follow-up of 10.7 months, ORR was 51.3% (of which 4.4% complete response) in the relatlimab arm versus 43.7% (2.6% complete response) in the placebo arm. The median duration of response was 10.1 months versus 9.1 months, respectively. The median progression-free survival (PFS) was 6.7 months versus 6.0 months (HR 0.88; 95% CI 0.71–1.11), respectively.

Subgroup analysis showed a statistically significant benefit of relatlimab over placebo in participants with PD-L1 ≥1%: ORR was 53.2% versus 40.8% and median PFS was 9.8 months versus 6.1 months with or without relatlimab, respectively. In addition, there was a trend for more benefit in participants with non-squamous histology. In participants with PD-L1 ≥1% and non-squamous histology (n=98), ORR was 58% versus 39.6% and median PFS was 11.6 months versus 6.9 months with or without relatlimab, respectively.

“These results provide a rationale to further explore the efficacy of relatlimab/nivolumab/chemotherapy in patients with PD-L1 ≥1% and non-squamous histology,” Prof. Girard concluded. However, discussant Dr Marina Garassino (University of Chicago, IL, USA) commented that the researchers had “carried out a series of cherrypicking analyses.” Randomised trials including relatlimab are now being initiated.

1. Tawbi HA, et al. N Eng J Med 2022;386:24-34.
2. Girard N, et al. Nivolumab (NIVO) plus relatlimab with platinum-doublet chemotherapy (PDCT) vs NIVO + PDCT as first-line (1L) treatment (tx) for stage IV or recurrent NSCLC: Results from the randomized phase II RELATIVITY-104 study. Abstract LBA53, ESMO Congress 2024, 13–17 September, Barcelona, Spain.

 

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Posted on 4 November 20244 November 2024