Patients Treated With Mirvetuximab Soravtansine vs Chemotherapy Report Better HRQOL

Patients treated with mirvetuximab soravtansine (Elahere; AbbVie) experienced improved health-related quality of life (HRQOL) compared with those on investigator’s choice chemotherapy in the phase 3 MIRASOL trial (NCT04209855), according to a study presented at the 2024 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer.¹

The MIRASOL trial met its primary and key secondary end points, making mirvetuximab soravtansine—a folate receptor ⍺ (FR⍺)–directed antibody and microtubule inhibitor conjugate—the first novel agent to demonstrate an overall survival benefit in platinum-resistant ovarian cancer (PROC) in a phase 3 trial. In the MIRASOL trial, patients with PROC received either mirvetuximab soravtansine or standard-of-care chemotherapy.

Based on the results of the MIRASOL trial, mirvetuximab soravtansine received full FDA approval for the treatment of FRα-positive PROC following 1 to 3 prior lines of therapy in March 2024.² The agent was granted accelerated approval in November 2023 following positive results from the SOYAYA study (Study 0417).

Ovaries illustration | Image credit: magicmine - stock.adobe.com

The abstract presented at the 2024 SGO Annual Meeting on Women’s Cancer explored HRQOL among patients treated with mirvetuximab soravtansine based on patient-reported outcomes (PROs) from the European Organization for Research and Treatment of Cancer (EORTC) QLQ-OV28.¹

The main assessment of PROs was a 15-point improvement in the abdominal/gastrointestinal symptom scale of the EORTC QLQ-OV28 by week 8 or 9, which served as one of the key secondary end points in the trial. Change in EORTC QLQ-OV28 scores from baseline was a prespecified exploratory analysis conducted with mixed-model repeated measures.

Overall, 21% of patients in the mirvetuximab soravtansine cohort and 15.3% in the standard-of-care chemotherapy group experienced a 15-point improvement in EORTC QLQ-OV28 scores by week 8/9 (P = .26). Statistically significant differences in mean change from baseline on the abdominal/gastrointestinal symptoms scale were seen favoring mirvetuximab soravtansine at all time points. At week 8/9, the difference was ­–5.0 (95% CI, –8.3 to –1.6; P = .0041), and at week 24, the difference was –6.0 (–10.2 to –1.8; P = .0056).

Anchor-based meaningful change analyses showed that an 11-point change in subscale score was clinically meaningful, and a sensitivity analysis based on that threshold found that 29% of patients in the mirvetuximab soravtansine cohort met the improvement threshold at week 8/9, compared with 18% of patients receiving investigator’s choice chemotherapy (P = .0318).

The authors concluded that HRQOL was better in the cohort of patients who received mirvetuximab soravtansine compared with those who received investigator’s choice chemotherapy.

“Patients treated with MIRV are more likely to maintain or improve on ovarian cancer-specific measures of HRQOL, with statistically significant improvements observed relative to investigator’s choice across all time points in abdominal/GI symptoms,” the authors concluded. “The efficacy and safety of mirvetuximab soravtansine are supported by PRO data from the MIRASOL trial and position mirvetuximab soravtansine as a new standard of care for patients with FR⍺-positive PROC.”

Reference

1. Konecny GE, Moore KN, Lebreton C, et al. Patient-reported outcome results from phase III MIRASOL trial of mirvetuximab soravtansine versus investigator's choice of chemotherapy in FRα-positive, platinum-resistant ovarian cancer. Abstract presented at: 2024 SGO Annual Meeting on Women’s Cancer. March 16-18, 2024; San Diego, CA.

2. McNulty R. Mirvetuximab soravtansine-gynx granted full FDA approval for FRα+ platinum-resistant ovarian cancer. AJMC. March 22, 2024. Accessed March 29, 2024. https://www.ajmc.com/view/mirvetuximab-soravtansine-gynx-granted-full-fda-approval-for-fr-platinum-resistant-ovarian-cancer