Gilbert Lucy, Oaknin Ana, Matulonis Ursula A, Mantia-Smaldone Gina M, Lim Peter C, Castro Cesar M, Provencher Diane, Memarzadeh Sanaz, Method Michael, Wang Jiuzhou, Moore Kathleen N, O'Malley David M
McGill University Health Center-Research Institute, Montreal, Canada.
Gynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
Gynecol Oncol. 2023 Mar;170:241-247. doi: 10.1016/j.ygyno.2023.01.020. Epub 2023 Feb 1.
Evaluate the antitumor activity and safety profile of the combination of mirvetuximab soravtansine and bevacizumab in patients with platinum-resistant ovarian cancer.
Patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, whose most recent platinum-free interval was ≤6 months, were administered mirvetuximab soravtansine (6 mg/kg adjusted ideal body weight) and bevacizumab (15 mg/kg), intravenously, once every 3 weeks. Eligibility included FRα expression by immunohistochemistry (IHC; ≥25% of cells with ≥2+ intensity). Prior bevacizumab and/or PARP inhibitor (PARPi) treatment were permitted. The primary endpoint was confirmed objective response rate (ORR). Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and safety.
Ninety-four patients received combination treatment with mirvetuximab soravtansine and bevacizumab. Median age was 62 years (range, 39-81). Fifty-two percent had ≥3 prior therapies; 59% had prior bevacizumab; and 27% had prior PARPi. ORR was 44% (95% CI 33, 54) with 5 complete responses, median DOR 9.7 months (95% CI 6.9, 14.1), and median PFS 8.2 months (95% CI 6.8, 10.0). Treatment-related adverse events were consistent with the profiles of each agent, with the most common being blurred vision (all grades 57%; grade 3, 1%), diarrhea (54%; grade 3, 1%), and nausea (51%; grade 3, 1%).
The mirvetuximab soravtansine plus bevacizumab doublet is an active and well-tolerated regimen in patients with FRα-expressing platinum-resistant ovarian cancer. Promising activity was observed for patients regardless of level of FRα expression or prior bevacizumab. These data underscore the potential for mirvetuximab soravtansine as the combination partner of choice for bevacizumab in this setting.
评估mirvetuximab soravtansine与贝伐单抗联合用药对铂耐药卵巢癌患者的抗肿瘤活性和安全性。
对复发性上皮性卵巢癌、输卵管癌或原发性腹膜癌患者，其最近一次无铂间期≤6个月，静脉给予mirvetuximab soravtansine（6mg/kg调整后的理想体重）和贝伐单抗（15mg/kg），每3周一次。入选标准包括免疫组化（IHC）检测FRα表达（≥25%的细胞强度≥2+）。允许既往使用过贝伐单抗和/或PARP抑制剂（PARPi）治疗。主要终点为确认的客观缓解率（ORR）。次要终点包括缓解持续时间（DOR）、无进展生存期（PFS）和安全性。
94例患者接受了mirvetuximab soravtansine与贝伐单抗的联合治疗。中位年龄为62岁（范围39-81岁）。52%的患者既往接受过≥3种治疗；59%的患者既往使用过贝伐单抗；27%的患者既往使用过PARPi。ORR为44%（95%CI 33,54），有5例完全缓解，中位DOR为9.7个月（95%CI 6.9,14.1），中位PFS为8.2个月（95%CI 6.8,10.0）。治疗相关不良事件与每种药物的特征一致，最常见的是视力模糊（所有级别57%；3级1%）、腹泻（54%；3级1%）和恶心（51%；3级1%）。
mirvetuximab soravtansine联合贝伐单抗方案对表达FRα的铂耐药卵巢癌患者具有活性且耐受性良好。无论FRα表达水平或既往是否使用过贝伐单抗，患者均观察到有前景的活性。这些数据强调了mirvetuximab soravtansine在这种情况下作为贝伐单抗首选联合用药伙伴的潜力。
