Patients with FRα+, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer may now be eligible for mirvetuximab soravtansine in the UK.
Mirvetuximab soravtansine (Elahere) has been granted conditional marketing authorization by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for patients with folate receptor-alpha–positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic therapies, according to a press release from AbbVie.1
This decision is based on the results of the phase 3 MIRASOL trial (NCT04209855), which assessed mirvetuximab soravtansine compared with the investigator’s choice of chemotherapy for patients in the aforementioned population. Updated results were shared at the 2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer.
“It is fantastic news that the MHRA has granted authorization for mirvetuximab soravtansine–this is a milestone for the treatment of eligible adult women with folate-receptor high platinum-resistant ovarian cancer in the UK. Treatment advances with novel mechanisms of action, like mirvetuximab soravtansine, are crucial for helping eligible women with this type of cancer,” Susana Banerjee, MBBS, MA, PhD, FRCP, consultant medical oncologist, research lead Gynecology Unit, The Royal Marsden NHS Foundation Trust, London, and professor in Women’s Cancers, the Institute of Cancer Research, London, said in the press release.
Patients were randomly assigned 1:1 to receive either mirvetuximab intravenously at 6 mg/kg based on an adjusted ideal body weight every 3 weeks or investigator’s choice of chemotherapy.
The primary end point was investigator-assessed progression-free survival (PFS), and key secondary end points were investigator-assessed overall response rate (ORR), overall survival (OS), and patient-reported outcomes.
At a median follow-up of 30.5 months, the median OS in the mirvetuximab arm was 16.85 months (95% CI, 14.36-19.78) vs 13.34 months (95% CI, 11.37-15.15) in the chemotherapy arm. This showed a 32% reduction in the risk of death (HR, 0.68; 95% CI, 0.54-0.84; P = .0004).
The median PFS was 5.59 months (95% CI, 4.34-5.88) in the mirvetuximab arm vs 3.98 months (95% CI, 2.86-4.47) in the chemotherapy arm, showing a 37% reduction in the risk of disease progression or death (HR, 0.63; 95% CI, 0.51-0.79; P <.0001).
Additionally, the ORR was 41.9% (95% CI, 35.4%-48.6%) in the mirvetuximab arm vs 15.9% (95% CI, 11.4%-21.4%) in the chemotherapy arm (OR, 3.75; 95% CI, 2.4-5.85). Complete responses were noted in 5.7% of patients in the mirvetuximab arm, 36.1% had a partial response, 38.3% had stable disease, 13.7% had disease progression, and 6.2% were not evaluable.
For mirvetuximab, the median duration of response was 6.93 months (95% CI, 5.78-8.84) vs 4.44 months (95% CI, 4.17-5.75) in the chemotherapy arm. Of note, the second PFS in each arm was 11.01 months (95% CI, 9.30-12.02) and 7.59 months (95% CI, 6.60-8.84; HR, 0.59; 95% CI, 0.480-0.728).
Regarding safety, any serious treatment-emergent adverse effects (TEAEs) were noted in 25% of patients in the mirvetuximab arm and 33% in the chemotherapy arm. Dose delays due to TEAEs were noted in 56% of patients in the mirvetuximab arm and 54% in the chemotherapy arm, dose reductions occurred in 35% vs 24%, and discontinuation in 11% vs 15%.
For mirvetuximab, the most common TEAEs included blurred vision (43%), keratopathy (33%), dry eye (29%), diarrhea (29%), nausea (27%), peripheral neuropathy (22%), neutropenia (11%), anemia (10%), thrombocytopenia (8%), stomatitis (4%), and alopecia (1%).
References
- AbbVie’s first in class therapy ELAHERE® (mirvetuximab soravtansine) licensed by the Medicines and Healthcare products Regulatory Agency for the treatment of eligible adult patients with platinum-resistant ovarian cancer. News release. Pharmiweb. July 24, 2025. Accessed July 25, 2025. https://tinyurl.com/z4aakpd2
- Van Gorp T, Angelergues A, Konecny G, et al. Final overall survival analysis among patients with FRα-positive, platinum-resistant ovarian cancer (PROC) treated with mirvetuximab soravtansine (MIRV) vs investigator’s choice chemotherapy (ICC) in the phase 3 MIRASOL (GOG 3045/ENGOT-ov55) study. Presented at: 2025 SGO Annual Meeting on Women’s Cancer; March 14-17, 2025; Seattle, WA. Abstract 939696.