一个新的治疗组合显示,对先进的前列腺癌有希望,较低剂量的治疗效果较好,没有严重的副作用。
A new treatment combo showed promise for advanced prostate cancer, with better results at a lower dose and no serious side effects.
在2025年ESMO大会上介绍的经过更新的第一阶段试验结果显示,将gedatollisib与darolutomide相结合,在接受过前受体抑制疗法治疗的具有经转移性抑制前列腺癌的男子中,无放射分程存活率为9.1个月,67%的RPFS为67%。
Updated Phase 1 trial results presented at the 2025 ESMO Congress show that combining gedatolisib with darolutamide yielded a median radiographic progression-free survival of 9.1 months and a 67% six-month rPFS rate in men with metastatic castration-resistant prostate cancer who had progressed on prior androgen receptor inhibitor therapy.
120毫克的gedatolisib剂量显示效果较强,中中RPFS为9.5个月,中RPFS为74%,中RPFS为6个月,而180毫克的剂量中RPFS为7.4个月,中RPFS为61%。
The 120 mg gedatolisib dose showed stronger efficacy, with a 9.5-month median rPFS and 74% six-month rPFS, while the 180 mg dose had a 7.4-month median rPFS and 61% six-month rPFS.
这种结合得到很好的容忍,没有与治疗有关的死亡、限制剂量的毒性或因不利事件而中止的症状,没有高血糖3级。
The combination was well tolerated, with no treatment-related deaths, dose-limiting toxicities, or discontinuations due to adverse events, and no Grade 3 hyperglycemia.
Celcuity目前正在将该研究推进为最新的第1/1b阶段试验,以确定所建议的第2阶段的剂量,计划将多达40名病人纳入第1b阶段,并在第2阶段剂量扩大研究中扩大到大约30名病人。
Celcuity is now advancing the study into an updated Phase 1/1b trial to determine the recommended Phase 2 dose, with plans to enroll up to 40 patients in Phase 1b and expand to approximately 30 patients in a Phase 2 dose expansion study.