Adding relatlimab to nivolumab improved progression-free survival (PFS) in patients with advanced melanoma, according to a phase 3 trial being presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

Relatlimab is a novel checkpoint inhibitor that binds to LAG-3. In the phase 3 RELATIVITY-047 trial (ClinicalTrials.gov Identifier: NCT03470922), researchers compared the safety and efficacy of relatlimab plus nivolumab to nivolumab monotherapy in patients with advanced melanoma.

The study included 714 patients who were randomly assigned 1:1 to receive nivolumab alone or a fixed-dose combination of relatlimab and nivolumab. All patients had previously untreated, unresectable, or metastatic disease.


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The median PFS was 10.1 months in the combination group and 4.6 months in the monotherapy group (hazard ratio, 0.75; P =.0055). The 1-year PFS rates were 47.7% and 36.0%, respectively.

Grade 3 to 4 treatment-related adverse events were more common in the combination group than in the monotherapy group (18.9% and 9.7%, respectively), as were all-grade treatment-related adverse events leading to discontinuation (14.6% and 6.7%, respectively).

There were 3 treatment-related deaths in the combination group (hemophagocytic lymphohistiocytosis, acute edema of the lung, and pneumonitis) and 2 in the monotherapy group (sepsis and myocarditis in 1 patient and worsening pneumonia in 1 patient).

Data on overall response rate and overall survival are forthcoming.

“This is the first phase 3 study to validate inhibition of the LAG-3 immune checkpoint as a therapeutic strategy for patients with cancer,” investigator Evan J. Lipson, MD, associate professor of oncology at the Johns Hopkins Kimmel Cancer Center and Bloomberg-Kimmel Institute for Cancer Immunotherapy in Baltimore, Maryland, said in a press release.

“Our findings establish the LAG-3 pathway as the third immune checkpoint pathway in history, after CTLA-4 and PD-1, for which blockade has clinical benefit,” Dr. Lipson added.

Disclosures: This research was supported by Bristol-Myers Squibb. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures. 

Reference

Lipson E, Tawbi H, Schadendorf D, et al. Relatlimab (RELA) plus nivolumab (NIVO) versus NIVO in first-line advanced melanoma: Primary phase III results from RELATIVITY-047 (CA224-047). J Clin Oncol 39, 2021 (suppl 15; abstr 9503).

This article originally appeared on Cancer Therapy Advisor