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Soo Park, MD
Soo Park, MD
Posted: Monday, March 10, 2025
In patients with advanced melanoma, clinical response to first-line immune checkpoint inhibitor therapy, evaluated in the initial months of treatment, strongly predicts long-term survival, according to research results published in the European Journal of Cancer. This holds true even in patients with biomarkers that might indicate poor prognosis, explained Caroline Robert, MD, PhD, of Gustave Roussy Institute, Villejuif-Paris, and colleagues. The information should “help clinicians counsel patients about long-term prognostic expectations based on response outcomes occurring within the first 3 to 12 months of treatment,” they added.
The team evaluated pooled 5-year data from 935 responders and nonresponders treated either with the PD-1 inhibitor nivolumab combined with the CTLA-4 inhibitor ipilimumab or nivolumab alone. All patients were enrollees in the CheckMate 069, 066, and 067 studies. In addition to looking at differences in outcomes between these regimens, the researchers sought to investigate how well Response Evaluation Criteria in Solid Tumors at 3, 6, or 12 months predicted long-term survival.
Response rates at any time were 58% (239 of 409 patients) for the nivolumab/ipilimumab combination and 44% (230 of 526 patients) for nivolumab alone, reported the authors. In 12-month landmark analyses, the 5-year overall survival rates for responders vs nonresponders were 82% vs 40% with nivolumab/ipilimumab (hazard ratio [HR] = 0.23) and 76% vs 32% with nivolumab monotherapy (HR = 0.22). For progression-free survival, the rates were 83% vs 32% and 69% vs 46%, respectively.
Similarly, strong associations between response at 3 and 6 months and 5-year overall survival and progression-free survival were seen: More than 70% of the responses were observed in the first 3 months. “Additionally, response rates correlated with baseline lactate dehydrogenase [LDH] and PD-L1 status by multivariate analysis, but the association between response and long-term survival was maintained in landmark analyses even among patients with high LDH and low PD-L1 expression,” noted Dr. Robert and co-investigators.
Disclosure: For full disclosures of the study authors, visit ejcancer.com.
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