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新辅助剂relatlimb和nivolumab治疗可切除黑色素瘤
2022-10-29 14:24

美国德州大学安德森癌症中心Rodabe N. Amaria等研究人员共同合作近期取得重要工作进展,他们研究发现新辅助剂relatlimb和nivolumab能够治疗可切除黑色素瘤。该项研究成果2022年10月26日在线发表于《自然》杂志上。

研究人员在可切除的临床III期或IV期低转移性黑色素瘤(NCT02519322)患者中研究了该方案。患者接受两次新辅助治疗(nivolumab 480毫克和relatlimab 160毫克,每4周静脉注射一次),然后进行手术,术后再接受10个剂量的辅助性联合治疗。主要终点为病理完全缓解(pCR)率。在接受治疗的30例患者中,联合治疗的结果是57%的pCR率和70%的总病理应答率。采用实体瘤反应评价标准1.1的放射学反应率为57%。在新辅助治疗中没有观察到3-4级的免疫相关不良事件。有任何病理反应的患者1年和2年无复发生存率分别为100%和92%,而无病理反应的患者为88%和55%(P =0.005)。基线时免疫细胞浸润增加,治疗期间M2巨噬细胞减少,与病理反应有关。

他们的结果表明,新辅助剂relatlimb和nivolumab诱导高pCR率。新辅助治疗的安全性优于其他联合免疫治疗方案。这些数据,结合RELATIVITY-047试验1的结果,进一步证实了新免疫治疗方案的有效性和安全性。

据介绍,Relatlimab和nivolumab联合免疫疗法比nivolumab单药疗法,更能改善不可切除的晚期黑色素瘤患者的无进展生存期。

附:英文原文

Title: Neoadjuvant relatlimab and nivolumab in resectable melanoma

Author: Amaria, Rodabe N., Postow, Michael, Burton, Elizabeth M., Tezlaff, Michael T., Ross, Merrick I., Torres-Cabala, Carlos, Glitza, Isabella C., Duan, Fei, Milton, Deni 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.

Issue&Volume: 2022-10-26

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 480mg and relatlimab 160mg 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.

DOI: 10.1038/s41586-022-05368-8

Source: https://www.nature.com/articles/s41586-022-05368-8

Nature:《自然》,创刊于1869年。隶属于施普林格·自然出版集团,最新IF:69.504
官方网址:http://www.nature.com/
投稿链接:http://www.nature.com/authors/submit_manuscript.html


本期文章:《自然》:Online/在线发表

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