Replimune Group Presented The Interim Results From The ARTACUS Clinical Trial Of RP1 Monotherapy In Solid Organ And Hematopoietic Cell Transplant Recipients With Skin Cancers At AACR 2024
Replimune Group Presented The Interim Results From The ARTACUS Clinical Trial Of RP1 Monotherapy In Solid Organ And Hematopoietic Cell Transplant Recipients With Skin Cancers At AACR 2024
In the study, treatment with RP1 as monotherapy, for up to 25 doses, resulted in an overall response rate (ORR) of 34.8 percent (8 of 23 evaluable patients, including 5 complete responses and 3 partial responses) with most responses ongoing as of the data cutoff date of September 18, 2023. In the evaluable patient population (n=23), 20 had cutaneous squamous cell carcinoma (CSCC) and three had merkel cell carcinoma. Of note, a patient treated with RP1 for CSCC also had a complete response of a new primary basal cell carcinoma which appeared post baseline. There was no evidence of allograft rejection including of hepatic and lung allografts. RP1 monotherapy was well tolerated, and the safety profile was similar to the profile in non-immunocompromised patients with advanced skin cancers. Additional biomarker data collected showed an increase in CD+8 T, a type of immune cell, and an increase in the expression of PD-L1, after treatment suggesting immune activation.
In the study, treatment with RP1 as monotherapy, for up to 25 doses, resulted in an overall response rate (ORR) of 34.8 percent (8 of 23 evaluable patients, including 5 complete responses and 3 partial responses) with most responses ongoing as of the data cutoff date of September 18, 2023. In the evaluable patient population (n=23), 20 had cutaneous squamous cell carcinoma (CSCC) and three had merkel cell carcinoma. Of note, a patient treated with RP1 for CSCC also had a complete response of a new primary basal cell carcinoma which appeared post baseline. There was no evidence of allograft rejection including of hepatic and lung allografts. RP1 monotherapy was well tolerated, and the safety profile was similar to the profile in non-immunocompromised patients with advanced skin cancers. Additional biomarker data collected showed an increase in CD+8 T, a type of immune cell, and an increase in the expression of PD-L1, after treatment suggesting immune activation.
在這項研究中,使用RP1作爲單一療法進行治療,最多25劑,總緩解率(ORR)爲34.8%(23名可評估患者中有8名,包括5例完全反應和3例部分反應),截至2023年9月18日數據截止日期,大多數反應仍在繼續。在可評估的患者群體(n=23)中,有20人患有皮膚鱗狀細胞癌(CSCC),3人患有默克爾細胞癌。值得注意的是,接受RP1治療的CSCC患者對基線後出現的新原發性基底細胞癌也有完全的反應。沒有證據顯示同種異體移植排斥反應,包括肝臟和肺部同種異體移植。RP1 單一療法耐受性良好,其安全性與非免疫功能低下晚期皮膚癌患者的特徵相似。收集的其他生物標誌物數據顯示,在治療提示免疫激活後,CD+8 T(一種免疫細胞)增加,PD-L1 的表達增加。
譯文內容由第三人軟體翻譯。
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