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October 27, 2022
Using combination immunotherapy of relatlimab and nivolumab can improve outcomes for patients with surgically removable, advanced melanoma, according to the results of a phase 2 clinical trial. The preliminary findings — presented in Nature — may provide further evidence for the efficacy and safety of this new combination therapy for advanced forms of the disease.
In March 2022, combination immunotherapy using the drugs relatlimab and nivolumab received approval from the US Food and Drug Administration (FDA) after favourable safety and efficacy results from the phase 2/3 RELATIVITY-047 trial of non-surgically removable, advanced metastatic melanoma.
To better understand the potential of this therapy for earlier stages of the disease, Rodabe Amaria and colleagues investigated this combination in 30 patients with surgically removable, advanced stage melanoma. Patients received two initial doses of relatlimab and nivolumab before surgery, followed by ten further doses; one patient did not undergo surgery. Overall, 17 patients achieved a pathologic complete response — defined as having no evidence for a tumour at the time of surgery — with around 70% of patients showing some evidence of responding to the treatment. No severe immune-related adverse events were observed during initial treatment. At follow-ups 1 and 2 years after surgery, survival with no evidence for tumour recurrence was 100% and 92%, respectively, for patients who experienced an initial pathologic response, compared with 88% and 55% for those who did not.
The authors conclude that although the sample size of the study was small, and further research will be needed to determine any longer-term clinical impact, these initial data are encouraging. Combined with results from previous trials, these findings may provide evidence for the value of using pathologic response rates as early predictors of the potential long-term benefits of treatment.
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