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Neoadjuvant relatlimab and nivolumab in resectable melanoma.

Rodabe N AmariaMichael PostowElizabeth M BurtonMichael T TezlaffMerrick I RossCarlos A Torres-CabalaIsabella C Glitza OlivaFei DuanDenái R MiltonKlaus J BusamLauren SimpsonJennifer Leigh McQuadeMichael K WongJeffrey E GershenwaldJeffrey E LeeRyan P GoepfertEmily Z KeungSarah B FisherAllison Betof WarnerAlexander N ShoushtariMargaret K CallahanDaniel CoitEdmund K BartlettDanielle BelloParisa MomtazCourtney NicholasAidi GuXuejun ZhangBrinda Rao KoriviMadhavi PatnanaSapna Pradyuman PatelAdi DiabAnthony LucciVictor G PrietoMichael A DaviesJames P AllisonPadmanee SharmaJennifer A WargoCharlotte AriyanHussein A Tawbi
Published in: Nature (2022)
Relatlimab and nivolumab combination immunotherapy improves progression-free survival over nivolumab monotherapy in patients with unresectable advanced melanoma 1 . We investigated this regimen in patients with resectable clinical stage III or oligometastatic stage IV melanoma (NCT02519322). Patients received two neoadjuvant doses (nivolumab 480 mg and relatlimab 160 mg intravenously every 4 weeks) followed by surgery, and then ten doses of adjuvant combination therapy. The primary end point was pathologic complete response (pCR) rate 2 . The combination resulted in 57% pCR rate and 70% overall pathologic response rate among 30 patients treated. The radiographic response rate using Response Evaluation Criteria in Solid Tumors 1.1 was 57%. No grade 3-4 immune-related adverse events were observed in the neoadjuvant setting. The 1- and 2-year recurrence-free survival rate was 100% and 92% for patients with any pathologic response, compared to 88% and 55% for patients who did not have a pathologic response (P = 0.005). Increased immune cell infiltration at baseline, and decrease in M2 macrophages during treatment, were associated with pathologic response. Our results indicate that neoadjuvant relatlimab and nivolumab induces a high pCR rate. Safety during neoadjuvant therapy is favourable compared to other combination immunotherapy regimens. These data, in combination with the results of the RELATIVITY-047 trial 1 , provide further confirmation of the efficacy and safety of this new immunotherapy regimen.
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