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Soo Park, MD
Soo Park, MD
Posted: Tuesday, June 4, 2024
Paolo Antonio Ascierto, MD, of the Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, and colleagues performed the RELATIVITY-048 trial, which evaluated the safety and efficacy of combination immunotherapy with nivolumab, relatlimab-rmbw, and ipilimumab in patients with advanced melanoma. Presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 9504), the results of this study suggest this triplet combination may offer a similar safety profile as that of other immunotherapy combinations.
“In RELATIVITY-048, nivolumab plus relatlimab plus ipilimumab demonstrated encouraging efficacy, with a confirmed objective response rate of 58.7% and a 48-month overall survival rate of 69.1%,” the study authors concluded. “Given the small sample size, additional studies are needed to confirm the efficacy and safety of [this combination].”
This phase I/II trial enrolled 46 patients with advanced melanoma (ClinicalTrials.gov identifier NCT03459222); prior (neo)adjuvant therapy was allowed if completed more than 6 months before trial initiation. Participants received 480 mg of nivolumab and 160 mg of relatlimab every 4 weeks, as well as 1 mg/kg of ipilimumab every 8 weeks. Therapy was continued until disease progression or unacceptable toxicity.
The median follow-up was 44.1 months, and 6.5% of patients underwent prior adjuvant therapy. Most patients had LAG3-positive disease (73.9%), 50.0% had BRAF-positive disease, and 26.1% had tumor cell PD-L1–positive disease. The disease control rate was 76.1%. The median progression-free survival and overall survival were not reached; however, the 48-month progression-free survival and overall survival rates were 51.6% and 69.1%, respectively.
Nearly all patients experienced a treatment-related adverse event of any grade (95.7%), whereas grade 3 or 4 events were reported in 39.1% of patients. A total of 19 patients discontinued treatment because of treatment-related adverse events; two deaths (rectal hemorrhage and dyspnea, immune-mediated myositis) were considered to be related to treatment.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.
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