Ocular Adverse Events From Mirvetuximab Soravtansine Not Associated With HRQoL Impact in FRα+ Ovarian Cancer

Treatment-emergent ocular events (TEOEs) in patients with folate receptor alpha-positive (FRα+), platinum-resistant ovarian cancer treated with mirvetuximab soravtansine (Elahere; AbbVie) during the phase 3 MIRASOL (NCT04209855) trial were not significantly associated with health-related quality of life (HRQoL) detriments, according to an oral presentation at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer.¹

New data from the phase 3 MIRASOL trial (NCT04209855) provide reassurance on the safety, tolerability, and overall benefit-risk of mirvetuximab soravtansine (Elahere; AbbVie) for patients with folate receptor alpha-positive (FRα+), platinum-resistant ovarian cancer. | Image Credit: Prostock-studio - stock.adobe.com

Mirvetuximab soravtansine received full FDA approval last March for the treatment of FRα+, platinum-resistant ovarian cancer, following 1 to 3 prior lines of therapy based on the primary analysis of the phase 3 MIRASOL trial.² It was previously granted accelerated approval in November 2022 based on results from the SOYAYA study (Study 0417).³

As presented during an oral presentation last week, data from the phase 3 MIRASOL trial were used to compare the HRQoL of patients treated with the intervention who experienced TEOEs vs those who did not.¹ Patients were classified into 2 cohorts based on the occurrence of TEOEs of interest: patients with TE blurred vision/keratopathy of any grade, and patients without TEOEs of any type. Blurred vision and keratopathy were the most common patient-reported TEOEs during the trial.

HRQoL outcomes included the EuroQol-5-Dimension-5 Level (EQ-5D-5L) and the global health status/quality of life (GHS/QoL) and physical functioning (PF) scales from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).

Patients were followed up to 21 weeks to assess the association between TEOE occurrence and HRQoL. Changes from baseline were analyzed using a mixed model for repeated measures, adjusted for key baseline covariates, baseline HRQoL measures, and treatment duration. Least squares mean difference (LSMD), 95% CIs, and corresponding P-values were reported.

Among the 195 patients included in this analysis, 91 experienced TE blurred vision/keratopathy, and 104 reported no TEOEs of any type. No statistically significant or clinically meaningful differences in the change from baseline between either cohort were observed at weeks 9, 15, or 21.

At week 21, LSMDs were 0.03 (95% CI, –0.05 to 0.11) for EQ-5D-5L, 0.98 (95% CI, –7.24 to 9.19) for EORTC QLQ-C30 GHS/QoL, and 1.59 (95% CI, –5.16 to 8.33) for EORTC QLQ-C30 PF (P > .05 for all). A sensitivity analysis showed consistent results, with no statistically significant differences in HRQoL over time. These findings suggest that the treatment benefit of mirvetuximab soravtansine outweighs the impact of TEOEs on HRQoL in this patient population, according to the study.

“These findings should hopefully provide reassurance to both patients and clinicians when discussing the safety, tolerability, and overall benefit-risk of Elahere,” investigator and presenter Tashanna Myers, MD, of Baystate Health, told The American Journal of Managed Care^® (AJMC^®) over email. “For patients, they provide reassurance that while ocular side effects may occur, they do not reduce overall well-being. For oncologists, the data reinforce Elahere’s strong survival benefit over chemotherapy, with a manageable safety profile, further establishing it as a new standard of care.”

Final Analysis Confirms Clinical Benefits

The final analysis of the phase 3 MIRASOL trial was also presented at the SGO Annual Meeting on Women’s Cancer. In a late-breaking session, investigator and presenter Toon Van Gorp, MD, PhD, of the University of Leuven informed attendees that patients treated with mirvetuximab soravtansine vs investigator’s choice chemotherapy continued to show significant improvements in progression-free and overall survival at 30.5 months median follow-up.⁴

These new data demonstrated that the mirvetuximab soravtansine group achieved a median progression-free survival of 5.59 months vs 3.98 months in the chemotherapy group, representing a 37% reduction in the risk of tumor progression or death (HR, 0.63; 95% CI, 0.51-0.79). Also, the mirvetuximab soravtansine group had a higher objective response rate (41.9%) than the chemotherapy group (15.9%).

Lastly, patients in the mirvetuximab soravtansine cohort experienced significantly longer median overall survival than those in the chemotherapy cohort (16.85 vs 13.34 months), representing a 32% reduction in the risk of death (HR, 0.68; 95% CI, 0.54-0.84).

In an interview with AJMC, Van Gorp expressed confidence in mirvetuximab soravtansine as an effective treatment for this patient population.⁵

“In my opinion, this means that mirvetuximab soravtansine should be considered as the standard of care for FRα+, platinum-resistant ovarian cancer,” he said. "It's also very important that we include FRα testing in our standard of care, that we do this from the start when the patient is first diagnosed with platinum-resistant ovarian cancer because I think it's really necessary that our patients receive this treatment.”

References

1. Myers TK, Moore KN, Gladieff L, et al. Impact of treatment-emergent ocular events on health-related quality of life in patients with FRα+ platinum-resistant ovarian cancer treated with mirvetuximab soravtansine: results from the MIRASOL study. Presented at the 2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO); Seattle, WA, March 14-17, 2025.
2. McNulty R. Mirvetuximab soravtansine-gynx granted full FDA approval for FRα+ platinum-resistant ovarian cancer. AJMC^®. March 22, 2024. Accessed March 17, 2025. https://www.ajmc.com/view/mirvetuximab-soravtansine-gynx-granted-full-fda-approval-for-fr-platinum-resistant-ovarian-cancer
3. Joszt L. FDA approves mirvetuximab soravtansine-gynx for platinum-resistant ovarian cancer. AJMC. November 15, 2022. Accessed March 17, 2025. https://www.ajmc.com/view/fda-approves-mirvetuximab-soravtansine-gynx-for-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 March 25, 2025. https://www.ajmc.com/view/updated-mirasol-data-confirms-efficacy-of-mirvetuximab-soravtansine-for-fr-platinum-resistant-ovarian-cancer
5. McCormick B, Van Gorp T. Dr Toon Van Gorp: mirvetuximab soravtansine should be global standard for FRα+ ovarian cancer. AJMC. March 20, 2025. Accessed March 25, 2025. https://www.ajmc.com/view/mirvetuximab-soravtansine-should-be-global-standard-for-fr-ovarian-cancer-dr-toon-van-gorp