Combination relatlimab and nivolumab yields a high pathologic complete response (pCR) rate in patients with resectable stage III or oligometastatic stage IV melanoma, according to a study published in Nature.
The phase 2 study (ClinicalTrials.gov Identifier: NCT02519322) enrolled 30 patients with resectable melanoma.
A total of 29 patients received 2 neoadjuvant doses of nivolumab (480 mg) and relatlimab (160 mg) intravenously every 4 weeks, which was followed by surgery. Patients then received 10 doses of adjuvant combination therapy.
The median follow-up was 24.4 months. The pCR rate was 57%, and the overall pathologic response rate was 70%. The radiographic response rate (all partial responses) was 57%, and the rate of stable disease was 33%.
The 1-year recurrence-free survival rate was 100% in patients with any pathologic response and 88% in those without a pathologic response. The 2-year recurrence-free survival rates were 92% and 55%, respectively.
No grade 3-4 immune-related adverse events were observed in the neoadjuvant setting, but 26% of patients experienced grade 3-4 immune-related adverse events in the adjuvant setting.
“As 33% of patients discontinued therapy before the planned full year of treatment, due to toxicity, it raises questions of whether continued dosing in the adjuvant setting is necessary following pathologic response to neoadjuvant therapy,” the researchers wrote. “Additionally, none of the patients who stopped therapy early due to toxicity have experienced a recurrence event.”
The researchers noted that ongoing trials are addressing the possibility of omitting adjuvant therapy or administering it only to poor responders.
“In summary, neoadjuvant relatlimab and nivolumab is a highly active regimen that achieves a 70% pathologic response rate with a favorable safety profile in patients with high-risk, resectable clinical stage III or oligometastatic stage IV melanoma,” the researchers concluded. “These data are complementary to the RELATIVITY-047 study in patients with unresectable metastatic melanoma, and together further support the promise of this new combination immunotherapy regimen in this disease.”
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Amaria RN, Postow M, Burton EM, et al. Neoadjuvant relatlimab and nivolumab in resectable melanoma. Nature. Published online October 26, 2022. doi:10.1038/s41586-022-05368-8