![]() ![]() Secondary end points included ORR per investigator assessment, OS, patient-reported outcomes, DOR, safety, CA-125 response, and time to second progression.Īdditional data showed that patients in the mirvetuximab soravtansine arm achieved an investigator-assessed ORR of 42% (95% CI, 35.8%-49.0%) vs 16% (95% CI, 11.4%-21.4%) for those in the chemotherapy arm. Investigator-assessed PFS served as the trial’s primary end point. Stratification factors included chemotherapy choice (paclitaxel vs PLD vs topotecan) and prior lines of therapy (1 vs 2 vs 3). Patients were randomly assigned 1:1 to received 6 mg/kg of mirvetuximab soravtansine once every 3 weeks or investigator’s choice of chemotherapy consisting of paclitaxel, pegylated liposomal doxorubicin (PLD), or topotecan. Patients with BRCA mutations were permitted to enroll. ![]() One to 3 prior lines of therapy were required, and prior treatment with bevacizumab (Avastin) and a PARP inhibitor was allowed. 2 Patients were required to have FRα disease with a positivity staining intensity of at least 2 among at least 75% of viable tumor cells per immunohistochemistry. The open-label, randomized, phase 3 MIRASOL study enrolled patients with Frα-positive, high-grade serous, platinum-resistant ovarian cancer defined as having a platinum-free interval of at least 6 months. MIRASOL is serving as a confirmatory trial following the ADC’s accelerated approval from the FDA. ![]() The FDA’s decision was supported by data from the phase 3 SORAYA trial (NCT04296890), which showed that patients with platinum-resistant, measurable disease who received at least 1 dose of the ADC (n = 104) experienced a confirmed overall response rate (ORR) of 31.7% (95% CI, 22.9%-41.6%) and a median duration of response (DOR) of 6.9 months (95% CI, 5.6-9.7). In November 2022, the FDA granted accelerated approval to mirvetuximab soravtansine for the treatment of adult patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic treatment regimens. We look forward to working closely with the EMA throughout the review process and to potentially bring this novel antibody-drug conjugate to Europe as early as 2024." “The acceptance of our MAA is another important regulatory milestone in the next chapter of story as we work diligently to deliver this new treatment option to patients with platinum-resistant ovarian cancer globally," Michael Vasconcelles, MD, executive vice president of Research, Development, and Medical Affairs at ImmunoGen, stated in a news release.1 “As the first novel medicine to have demonstrated an OS benefit in platinum-resistant ovarian cancer compared to chemotherapy in a phase 3 clinical trial, we are pleased to initiate the review process that moves us one step closer to providing access to for eligible patients in Europe. Data presented at the 2023 ASCO Annual Meeting showed that patients treated with mirvetuximab soravtansine (n = 227) experienced a median progression-free survival (PFS) of 5.62 months (95% CI, 4.34-5.95) compared with 3.98 months (95% CI, 2.86-4.47) for patients given investigator’s choice of chemotherapy (n = 226) per investigator assessment (HR, 0.65 95% CI, 0.52-0.81 P <. ![]() The MAA is supported by data from the phase 3 MIRASOL trial (NCT04209855). The European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) seeking the approval of mirvetuximab soravtansine-gynx (Elahere) for the treatment of patients with folate receptor alpha (FRα)–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |