Mirvetuximab Soravtansine Demonstrates Promising Efficacy, Safety in Platinum-Resistant Recurrent Ovarian Cancer

Mirvetuximab soravtansine (MIRV; Elahere; AbbVie) demonstrated significant efficacy and an acceptable safety profile in the treatment of recurrent ovarian cancer, showing particular promise in patients with platinum-resistant disease and high folate receptor-α (FRα) expression, according to a study published in Discover Oncology.¹

Filling Evidence Gaps in Platinum-Resistant Ovarian Cancer

Standard ovarian cancer treatment typically involves cytoreductive debulking surgery followed by either neoadjuvant or postoperative platinum-based chemotherapy. While most patients initially respond, approximately 75% experience recurrence, and nearly all eventually develop platinum-resistant disease; the researchers noted that this underscores recurrence and platinum resistance as 2 of the greatest challenges in ovarian cancer management.

Targeted therapies and immunotherapies have advanced rapidly in recent years, with research increasingly focused on identifying molecular targets for ovarian cancer. FRα has been shown to contribute to the migratory and invasive potential of ovarian cancer cells, driving the development of FRα-directed therapies.

MIRV, the first FRα-targeting antibody-drug conjugate, received accelerated FDA approval in November 2022 for platinum-resistant ovarian cancer based on results from the SOYAYA study (Study 0417) and was granted full approval in March 2024 following the confirmatory phase 3 MIRASOL trial (NCT04209855).^2-4 However, most evidence supporting MIRV’s efficacy has come from single-arm studies, prompting the researchers to conduct a meta-analysis to more comprehensively assess its efficacy and safety, particularly in platinum-resistant ovarian cancer.

They performed a comprehensive search of PubMed, EMBASE, and the Cochrane Library to identify relevant articles published through August 31, 2025. Data extracted included progression-free survival (PFS), overall response rate (ORR), overall survival (OS), duration of response (DOR), cancer antigen (CA)–125 response, and treatment-related adverse events (TRAEs).

Improved Outcomes Observed With MIRV Combination Regimens

The researchers initially identified 496 relevant publications but only included 12 in their analysis. The study population consisted of 1057 patients with recurrent ovarian cancer treated with MIRV. Of these, 948 were platinum-resistant, 137 were platinum-sensitive, and 27 had unclear platinum status.

Regarding FRα expression, 795 had high expression, 72 had medium expression, 40 had low expression, and 205 were unspecified. In terms of treatment regimens, 839 received MIRV monotherapy, while 273 received combination therapies. Specifically, 177 received MIRV with bevacizumab, 55 received MIRV with pembrolizumab, and 41 received MIRV with carboplatin plus bevacizumab.

The overall pooled PFS was 6.28 months (95% CI, 5.70-6.87). In subgroup analyses, PFS was 5.74 months (95% CI, 5.23-6.23) for platinum-resistant patients and 5.72 months (95% CI, 5.14-6.29) for platinum-resistant patients with high FRα expression.

MIRV monotherapy yielded 5.46 months PFS (95% CI, 4.91-6.01), while higher PFS values were observed for combination regimens: 13.50 months (95% CI, 10.30-16.70) for MIRV plus bevacizumab and carboplatin, 7.66 months (95% CI, 6.45-8.87) for MIRV plus bevacizumab, and 4.20 months (95% CI, 2.80-5.60) for MIRV plus pembrolizumab.

Additionally, the overall pooled ORR was 37% (95% CI, 34%-40%). Platinum-sensitive patients achieved a higher pooled ORR (63%; 95% CI, 54%-71%) than platinum-resistant patients (34%; 95% CI, 31%-37%). Meanwhile, the ORR was 38% (95% CI, 34%-42%) among platinum-resistant patients with high FRα expression. ORRs by treatment were 35% (95% CI, 31%-38%) for MIRV monotherapy, 42% (95% CI, 34%-50%) for MIRV plus bevacizumab, and 83% (95% CI, 70%-96%) for MIRV plus bevacizumab and carboplatin.

Also, the overall pooled DOR estimate was 7.69 months (95% CI, 6.80-8.58) and 7.47 months (95% CI, 6.55-8.40) for platinum-resistant patients. MIRV monotherapy had a pooled DOR of 6.86 months (95% CI, 5.90-7.81), whereas MIRV plus bevacizumab had a pooled DOR of 9.25 months in platinum-resistant patients (95% CI, 6.96-11.53). Meanwhile, the pooled OS was 16.00 months (95% CI, 12.36-19.63), and the pooled CA-125 response rate was 59% (95% CI, 53%-64%).

Regarding safety, the overall incidence of TRAEs was 93.0% (95% CI, 92%-95%), with severe (grade ≥3) events occurring in 34% of patients (95% CI, 31%-37%). The most common all-grade TRAEs were blurred vision (45%; 95% CI, 42%-48%), nausea (39%; 95% CI, 37%-42%), and diarrhea (37%; 95% CI, 34%-39%). Lastly, the most frequent severe TRAEs were hypertension (14%; 95% CI, 9%-20%), thrombocytopenia (12%; 95% CI, 8%-16%), and keratopathy (7%; 95% CI, 5%-9%).

“…This meta-analysis demonstrates that MIRV offers promising efficacy and an acceptable safety profile in the management of recurrent ovarian cancer,” the authors wrote.

Expanding Clinical Evidence and Understanding of MIRV

The researchers acknowledged several limitations, one of which was that the included studies had limited comparability, as they ranged from phase 1 to 3. Additionally, not all studies provided sufficient data. Despite these limitations, they expressed confidence in their findings and used them to identify areas for further research.

“…Further clinical trials are warranted to clarify its underlying mechanisms and to validate the clinical effectiveness of MIRV across diverse patient populations,” the authors concluded.

References

1. Dai Q, Tang J, Du T, Huang Q. The efficacy and safety of mirvetuximab soravtansine for the treatment of recurrent ovarian cancer: an update systematic review and meta-analysis. Discov Oncol. 2025;16(1):2097. doi:10.1007/s12672-025-03933-x
2. Joszt L. FDA approves Mirvetuximab soravtansine-gynx for platinum-resistant ovarian cancer. AJMC^®. November 15, 2022. Accessed November 27, 2025. https://www.ajmc.com/view/fda-approves-mirvetuximab-soravtansine-gynx-for-platinum-resistant-ovarian-cancer
3. McNulty R. Mirvetuximab soravtansine-gynx granted full FDA approval for FRα+ platinum-resistant ovarian cancer. AJMC. March 22, 2024. Accessed November 27, 2025. https://www.ajmc.com/view/mirvetuximab-soravtansine-gynx-granted-full-fda-approval-for-fr-platinum-resistant-ovarian-cancer
4. McCormick B. Updated MIRASOL data confirm efficacy of mirvetuximab soravtansine for FRα+ platinum-resistant ovarian cancer. AJMC. March 17, 2025. Accessed November 27, 2025. https://www.ajmc.com/view/updated-mirasol-data-confirms-efficacy-of-mirvetuximab-soravtansine-for-fr-platinum-resistant-ovarian-cancer