Neoadjuvant relatlimab and nivolumab in resectable melanoma.
Neoadjuvant relatlimab and nivolumab in resectable melanoma.
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可切除黑色素瘤中的新辅助瑞拉利单抗和纳武利尤单抗
DOI：
10.1038/s41586-022-05368-8
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发表时间：
2022-11
期刊：
影响因子：
64.8
通讯作者：
Tawbi, Hussein A.
中科院分区：
文献类型：
--
作者：
Amaria, Rodabe N.;Postow, Michael;Burton, Elizabeth M.;Tezlaff, Michael T.;Ross, Merrick, I;Torres-Cabala, Carlos;Glitza, Isabella C.;Duan, Fei;Milton, Denai R.;Busam, Klaus;Simpson, Lauren;McQuade, Jennifer L.;Wong, Michael K.;Gershenwald, Jeffrey E.;Lee, Jeffrey E.;Goepfert, Ryan P.;Keung, Emily Z.;Fisher, Sarah B.;Betof-Warner, Allison;Shoushtari, Alexander N.;Callahan, Margaret;Coit, Daniel;Bartlett, Edmund K.;Bello, Danielle;Momtaz, Parisa;Nicholas, Courtney;Gu, Aidi;Zhang, Xuejun;Korivi, Brinda Rao;Patnana, Madhavi;Patel, Sapna P.;Diab, Adi;Lucci, Anthony;Prieto, Victor G.;Davies, Michael A.;Allison, James P.;Sharma, Padmanee;Wargo, Jennifer A.;Ariyan, Charlotte;Tawbi, Hussein A.
Relatlimab和nivolumab联合免疫治疗与nivolumab单药治疗相比可改善不可切除的晚期黑色素瘤患者的无进展生存期我们在可切除的临床III期或寡转移性IV期黑色素瘤患者中研究了该方案（NCT 02519322）。患者接受两次新辅助剂量（nivolumab 480 mg和relatlimab 160 mg，静脉注射，每4周一次），随后进行手术，然后接受10次辅助联合治疗。主要终点是病理完全缓解（pCR）率。在30例接受治疗的患者中，联合治疗导致57%的pCR率和70%的总体病理学缓解率。采用实体瘤缓解评价标准1.1，放射学缓解率为57%。在新辅助治疗中未观察到3-4级免疫相关不良事件。1年和2年无复发生存率为100%和92%的患者有任何病理反应，相比之下，88%和55%的患者没有病理反应（P = 0.005）。基线时免疫细胞浸润增加和治疗期间M2巨噬细胞减少与病理学反应相关。我们的结果表明，新辅助剂relatlimab和nivolumab诱导高pCR率。与其他联合免疫治疗方案相比，新辅助治疗期间的安全性有利。这些数据与RELATIVITY-047试验的结果相结合，进一步证实了这种新的免疫治疗方案的有效性和安全性。可切除的临床III期或寡转移性IV期黑色素瘤患者接受新辅助relatlimab和nivolumab联合免疫治疗，诱导了较高的病理完全缓解率，表明该方案的有效性和安全性。
Relatlimab and nivolumab combination immunotherapy improves progression-free survival over nivolumab monotherapy in patients with unresectable advanced melanoma. 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. 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, provide further confirmation of the efficacy and safety of this new immunotherapy regimen. Patients with resectable clinical stage III or oligometastatic stage IV melanoma were given neoadjuvant relatlimab and nivolumab combination immunotherapy, which induced a high pathologic complete response rate, indicating the efficacy and safety of this regimen.
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影响因子：
8.4
作者：
Eisenhauer, E. A.;Therasse, P.;Verweij, J.
通讯作者：
Verweij, J.
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影响因子：
11.4
作者：
Llaó-Cid L;Roessner PM;Chapaprieta V;Öztürk S;Roider T;Bordas M;Izcue A;Colomer D;Dietrich S;Stilgenbauer S;Hanna B;Martín-Subero JI;Seiffert M
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Seiffert M
影响因子：
64.8
作者：
Helmink BA;Reddy SM;Gao J;Zhang S;Basar R;Thakur R;Yizhak K;Sade-Feldman M;Blando J;Han G;Gopalakrishnan V;Xi Y;Zhao H;Amaria RN;Tawbi HA;Cogdill AP;Liu W;LeBleu VS;Kugeratski FG;Patel S;Davies MA;Hwu P;Lee JE;Gershenwald JE;Lucci A;Arora R;Woodman S;Keung EZ;Gaudreau PO;Reuben A;Spencer CN;Burton EM;Haydu LE;Lazar AJ;Zapassodi R;Hudgens CW;Ledesma DA;Ong S;Bailey M;Warren S;Rao D;Krijgsman O;Rozeman EA;Peeper D;Blank CU;Schumacher TN;Butterfield LH;Zelazowska MA;McBride KM;Kalluri R;Allison J;Petitprez F;Fridman WH;Sautès-Fridman C;Hacohen N;Rezvani K;Sharma P;Tetzlaff MT;Wang L;Wargo JA
通讯作者：
Wargo JA
影响因子：
50.5
作者：
Tetzlaff, M. T.;Messina, J. L.;Scolyer, R. A.
通讯作者：
Scolyer, R. A.
影响因子：
158.5
作者：
Long, G. V.;Hauschild, A.;Kirkwood, J. M.
通讯作者：
Kirkwood, J. M.