Dr Konecny on PROs From the MIRASOL Trial in Advanced Ovarian Cancer

Gottfried Konecny, MD, lead clinician, gynecologic oncology, Department of Medicine, University of California, Los Angeles Health, discusses the importance of evaluating patient-reported outcomes (PROs) from the phase 3 MIRASOL trial (Study 0416; NCT04209855), which evaluated mirvetuximab soravtansine-gynx (Elahere) in patients with folate receptor α (FRα)–positive, platinum-resistant ovarian cancer.

The objective of the study was to determine whether this treatment leads to an enhanced quality of life (QOL), as well as whether patients treated with mirvetuximab soravtansine experienced improved abdominal symptoms, compared with investigator’s choice of chemotherapy, Konecny begins. The challenge lies in defining what constitutes a “meaningful” improvement, as experts may have differing opinions on this matter, he states. To assess improvement in abdominal symptoms, patients initially rated their baseline symptoms on a scale from no adverse events (AEs) to severe AEs, he explains.

The study examined whether a decrease of 15 points or 10 points on this scale was clinically relevant. Many studies consider a 10-point decrease as a significant improvement in gastrointestinal (GI)-related symptoms according to the EORTC QLQ-OV28 questionnaire, he adds. Analysis of the outcome data revealed that 21% of patients receiving mirvetuximab soravtansine experienced a significant improvement in abdominal symptoms at week 8/9 compared with 15% of patients receiving standard-of-care treatment (P = .2611), Konecny reports. Notably, 29% of patients treated with mirvetuximab soravtansine achieved an 11-point or greater improvement in abdominal symptoms at week 8/9 compared with 18% of those receiving investigator's choice of chemotherapy (P = .0318).

Furthermore, mirvetuximab soravtansine consistently improved abdominal symptom outcomes at each assessment time point, he continues. These findings align with the favorable efficacy and safety outcomes observed with mirvetuximab soravtansine, reinforcing its positive impact on QOL as assessed through a rigorous QOL questionnaire, Konecny emphasizes.

These results support the notion that mirvetuximab soravtansine is well tolerated, allowing patients to remain on treatment for extended periods without cumulative toxicity, according to Konecny. Patients treated with this novel therapy experienced fewer AEs and had improvement in abdominal symptoms compared with those receiving standard chemotherapy, Konecny concludes.