US Oncology Research, Texas Oncology, The Woodlands, Texas, USA
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
Int J Gynecol Cancer. 2024 Aug 5;34(8):1119-1125. doi: 10.1136/ijgc-2024-005401.
The single-arm, phase II SORAYA trial (NCT04296890) of mirvetuximab soravtansine-gynx in folate receptor alpha (FRα)-high platinum-resistant ovarian cancer (n=105 (efficacy-evaluable)) met its primary endpoint with an objective response rate of 32.4% (95% CI, 23.6 to 42.2). Here we report final SORAYA trial results for overall survival and post hoc objective response rates in subgroups by sequence and number of prior therapies.
Eligible patients had high-grade serous platinum-resistant ovarian cancer with high FRα expression and one to three prior therapies (prior bevacizumab required). Enrolled participants received 6 mg/kg mirvetuximab soravtansine-gynx adjusted ideal body weight intravenously once every 3 weeks until progressive disease, unacceptable toxicity, withdrawal of consent, or death. Final overall survival and post hoc objective response rates were assessed in efficacy-evaluable participants. The safety population included all patients who received ≥1 dose of mirvetuximab soravtansine-gynx.
At data cut-off (December 22, 2022; n=105), final median overall survival was 15.0 months (95% CI, 11.5 to 18.7). Median overall survival in participants with one to two prior therapy lines was 18.7 months (95% CI, 13.8 to not estimable (NE)) and 11.6 months (95% CI, 7.1 to 16.7) with three prior therapy lines. Median overall survival was 15.0 months (95% CI, 11.5 to NE) in participants with prior poly (ADP-ribose) polymerase inhibitor (PARPi) treatment versus 14.0 months (95% CI, 7.1 to NE) in those without. Objective response rate (data cut-off: November 17, 2021) differed among participants who received mirvetuximab soravtansine-gynx as their first treatment in the platinum-resistant setting (34.8%; 95% CI, 23.5 to 47.6) versus a different first treatment (28.2%; 95% CI, 15.0 to 44.9) or had received prior bevacizumab in a platinum-sensitive (34.0%; 95% CI, 24.6 to 44.5) versus platinum-resistant setting (17.6%; 95% CI, 3.8 to 43.4). No new safety signals were observed.
These results support the clinically meaningful efficacy of mirvetuximab soravtansine-gynx in FRα-expressing platinum-resistant ovarian cancer, irrespective of prior treatment or sequence.
单臂、II 期 SORAYA 试验（NCT04296890）评估了 mirvetuximab soravtansine-gynx 在叶酸受体 α（FRα）高表达的铂耐药卵巢癌（n=105（疗效可评估））中的疗效，其客观缓解率为 32.4%（95%CI，23.6 至 42.2），达到了主要终点。在此，我们报告了 SORAYA 试验的最终结果，包括总生存期和按治疗顺序和先前治疗次数分组的事后客观缓解率。
符合条件的患者为 FRα 高表达的高级别浆液性铂耐药卵巢癌，且接受过 1 至 3 种治疗方案（先前需要接受贝伐珠单抗治疗）。入组患者接受 6mg/kg 的 mirvetuximab soravtansine-gynx 按理想体重静脉输注，每 3 周 1 次，直至疾病进展、不可接受的毒性、患者撤回同意或死亡。在疗效可评估的参与者中评估最终总生存期和事后客观缓解率。安全性人群包括接受了≥1 剂 mirvetuximab soravtansine-gynx 的所有患者。
截至数据截止日期（2022 年 12 月 22 日；n=105），最终中位总生存期为 15.0 个月（95%CI，11.5 至 18.7）。有 1 至 2 线既往治疗的参与者的中位总生存期为 18.7 个月（95%CI，13.8 至无法估计（NE）），3 线既往治疗的参与者为 11.6 个月（95%CI，7.1 至 16.7）。有既往聚二磷酸腺苷核糖聚合酶抑制剂（PARPi）治疗的参与者的中位总生存期为 15.0 个月（95%CI，11.5 至 NE），而无 PARPi 治疗的参与者为 14.0 个月（95%CI，7.1 至 NE）。接受 mirvetuximab soravtansine-gynx 作为铂耐药环境下首次治疗的参与者的客观缓解率（数据截止日期：2021 年 11 月 17 日）与首次接受其他治疗（34.8%；95%CI，23.5 至 47.6）或既往接受贝伐珠单抗治疗的铂敏感环境（34.0%；95%CI，24.6 至 44.5）的参与者有所不同（28.2%；95%CI，15.0 至 44.9）。未观察到新的安全性信号。
这些结果支持 mirvetuximab soravtansine-gynx 在 FRα 表达的铂耐药卵巢癌中的临床疗效，无论先前的治疗方案或治疗顺序如何。
