Research in Context

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MIRASOL patient-reported outcomes in FRα-positive platinum-resistant ovarian cancer

In this open-label, randomised phase 3 trial, the primary patient-reported outcome did not reach statistical significance, though MIRV did not seem to impair health-related quality of life versus chemotherapy.

  • Toon Van Gorp, MD; Kathleen N Moore, MD; Gottfried E Konecny, MD; Alexandra Leary, MD; Yolanda García-García, MD; Susana Banerjee, PhD; et al.

  • April 1, 2025

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Evidence before this study

We searched PubMed for clinical trial reports in English (from database inception to June 4, 2024) to identify other phase 3 clinical trials in platinum-resistant ovarian cancer that included patient-reported outcomes. Terms used in the search were “platinum-resistant ovarian cancer” OR “PROC” AND “clinical trial” AND “patient-reported outcome” OR “PRO” using US English spellings. The published literature revealed that few clinical trials in platinum-resistant ovarian cancer have reported patient-reported outcomes, and of those that included these measures, the quality of reporting was poor. Among phase 3 clinical trials in platinum-resistant ovarian cancer published between 2000 and 2016, fewer than 30% met regulatory body recommendations for the reporting of patient-reported outcomes. Thus, the generalisability of patient-reported outcomes findings is limited within this disease setting. The confirmatory, global, open-label, randomised, phase 3 MIRASOL trial of mirvetuximab soravtansine-gynx (MIRV) was, to the best of our knowledge, the first and only phase 3 trial in platinum-resistant ovarian cancer to demonstrate an overall survival advantage over single-agent chemotherapy. Understanding how MIRV therapy affected patient-reported outcomes in MIRASOL is crucial, not only to help fill this knowledge gap in the field but also to help patients with platinum-resistant ovarian cancer and their health-care providers make informed treatment decisions.

Added value of this study

Our results show that treatment with MIRV, a first-in-class antibody–drug conjugate comprising a folate receptor α (FRα) antibody, cleavable linker, and the tubulin-targeting maytansinoid DM4, does not seem to impair health-related quality of life compared with chemotherapy alone. Although statistical significance was not reached for the primary patient-reported outcome measure of a 15·0-point or greater improvement in abdominal and gastrointestinal symptoms, prespecified sensitivity analysis demonstrated nominally significant improvement with MIRV compared with investigator's choice of chemotherapy. Nominally significant improvement or maintenance of other health-related quality of life patient-reported outcome scores were additionally reached in the MIRV group versus the investigator's choice chemotherapy group.

Implications of all the available evidence

Given that the design of antibody–drug conjugates is intended to increase tolerability and improve therapeutic index by reducing systemic exposure to potent anticancer agents, it is crucial to not only compare the efficacy of MIRV with chemotherapy, but also assess its effect on treatment tolerability to identify possible quality of life benefits for patients. Results from this study demonstrate MIRV does not impair patient quality of life, underscoring the benefits of MIRV therapy including a survival advantage and tolerable safety profile compared with single-agent chemotherapy. Together, these data further support MIRV as a new standard-of-care treatment for patients with FRα-positive platinum-resistant ovarian cancer.

Source: The Lancet Oncology

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