Neoadjuvant relatlimab and nivolumab in resectable melanoma

Rodabe N. Amaria (), Michael Postow, Elizabeth M. Burton, Michael T. Tetzlaff, Merrick I. Ross, Carlos Torres-Cabala, Isabella C. Glitza, Fei Duan, Denái R. Milton, Klaus Busam, Lauren Simpson, Jennifer L. McQuade, Michael K. Wong, Jeffrey E. Gershenwald, Jeffrey E. Lee, Ryan P. Goepfert, Emily Z. Keung, Sarah B. Fisher, Allison Betof-Warner, Alexander N. Shoushtari, Margaret Callahan, Daniel Coit, Edmund K. Bartlett, Danielle Bello, Parisa Momtaz, Courtney Nicholas, Aidi Gu, Xuejun Zhang, Brinda Rao Korivi, Madhavi Patnana, Sapna P. Patel, Adi Diab, Anthony Lucci, Victor G. Prieto, Michael A. Davies, James P. Allison, Padmanee Sharma, Jennifer A. Wargo, Charlotte Ariyan and Hussein A. Tawbi
Additional contact information
Rodabe N. Amaria: The University of Texas MD Anderson Cancer Center
Michael Postow: Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College
Elizabeth M. Burton: The University of Texas MD Anderson Cancer Center
Michael T. Tetzlaff: The University of California San Francisco
Merrick I. Ross: The University of Texas MD Anderson Cancer Center
Carlos Torres-Cabala: The University of Texas MD Anderson Cancer Center
Isabella C. Glitza: The University of Texas MD Anderson Cancer Center
Fei Duan: The University of Texas MD Anderson Cancer Center
Denái R. Milton: The University of Texas MD Anderson Cancer Center
Klaus Busam: Memorial Sloan Kettering Cancer Center
Lauren Simpson: The University of Texas MD Anderson Cancer Center
Jennifer L. McQuade: The University of Texas MD Anderson Cancer Center
Michael K. Wong: The University of Texas MD Anderson Cancer Center
Jeffrey E. Gershenwald: The University of Texas MD Anderson Cancer Center
Jeffrey E. Lee: The University of Texas MD Anderson Cancer Center
Ryan P. Goepfert: The University of Texas MD Anderson Cancer Center
Emily Z. Keung: The University of Texas MD Anderson Cancer Center
Sarah B. Fisher: The University of Texas MD Anderson Cancer Center
Allison Betof-Warner: Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College
Alexander N. Shoushtari: Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College
Margaret Callahan: Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College
Daniel Coit: Memorial Sloan Kettering Cancer Center
Edmund K. Bartlett: Memorial Sloan Kettering Cancer Center
Danielle Bello: Memorial Sloan Kettering Cancer Center
Parisa Momtaz: Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College
Courtney Nicholas: The University of Texas MD Anderson Cancer Center
Aidi Gu: The University of Texas MD Anderson Cancer Center
Xuejun Zhang: The University of Texas MD Anderson Cancer Center
Brinda Rao Korivi: The University of Texas MD Anderson Cancer Center
Madhavi Patnana: The University of Texas MD Anderson Cancer Center
Sapna P. Patel: The University of Texas MD Anderson Cancer Center
Adi Diab: The University of Texas MD Anderson Cancer Center
Anthony Lucci: The University of Texas MD Anderson Cancer Center
Victor G. Prieto: The University of Texas MD Anderson Cancer Center
Michael A. Davies: The University of Texas MD Anderson Cancer Center
James P. Allison: The University of Texas MD Anderson Cancer Center
Padmanee Sharma: The University of Texas MD Anderson Cancer Center
Jennifer A. Wargo: The University of Texas MD Anderson Cancer Center
Charlotte Ariyan: Memorial Sloan Kettering Cancer Center
Hussein A. Tawbi: The University of Texas MD Anderson Cancer Center

Nature, 2022, vol. 611, issue 7934, 155-160

Abstract: Abstract Relatlimab and nivolumab combination immunotherapy improves progression-free survival over nivolumab monotherapy in patients with unresectable advanced melanoma1. 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) rate2. 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 trial1, provide further confirmation of the efficacy and safety of this new immunotherapy regimen.

Date: 2022
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DOI: 10.1038/s41586-022-05368-8

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