In an analysis from the phase III MIRASOL trial reported in The Lancet Oncology, Van Gorp et al found no significant difference in quality of life between patients receiving mirvetuximab soravtansine vs chemotherapy for folate receptor–alpha (FRα)-positive, platinum-resistant ovarian cancer.
In the primary analysis of the trial, mirvetuximab soravtansine was associated with significantly better progression-free survival vs investigator’s choice of chemotherapy (5.62 vs 3.98 months, hazard ratio = 0.65, P < .0001), as well as significant improvements in objective response rate and overall survival.
Study Details
In the open-label trial, 453 patients from sites in 21 countries were randomly assigned between February 2020 and August 2022 to receive mirvetuximab soravtansine at 6 mg/kg every 3 weeks (n = 227) or investigator’s choice of chemotherapy (n = 227), consisting of paclitaxel (41%), pegylated liposomal doxorubicin (36%), or topotecan (23%) selected before random assignment. Patients had confirmed diagnosis of platinum-resistant, recurrent high-grade serous epithelial ovarian cancer, had received one to three previous systemic anticancer therapies, and had high FRα tumor expression. A secondary outcome measure was a 15.0-point or greater improvement at week 8 or 9 in abdominal and gastrointestinal symptoms using the EORTC Quality-of-Life Questionnaire–Ovarian Cancer Module (EORTC QLQ-OV28).
Key Findings
The EORTC QLQ-OV28 was completed by 86% of patients at baseline and by 81% at week 8 or 9. A 15.0 point or greater improvement in abdominal and gastrointestinal symptoms at week 8 or 9 was reported by 34 of 162 patients (21.0%, 95% confidence interval [CI] = 15.0%–28.1%) treated with mirvetuximab soravtansine and 23 of 150 patients (15.3%, 95% CI = 10.0%–22.1%) treated with the investigator’s choice of chemotherapy (odds ratio [OR] = 1.5, 95% CI = 0.8–2.6, P = .26).
A post hoc analysis using an 11.1-point threshold for improvement among patients with both baseline and week 8 or 9 data for abdominal and gastrointestinal outcomes showed improvement in 33% of patients receiving mirvetuximab soravtansine vs 22% of those receiving chemotherapy (P = .045).
Exploratory analysis of additional EORTC QLQ-OV28 subscales showed no significant differences between the mirvetuximab soravtansine group vs the chemotherapy group at week 8 or 9 in peripheral neuropathy or sexual function. A significant benefit was observed in the mirvetuximab soravtansine group in reporting improved attitude toward disease and treatment (25.5% vs 11.4%, OR = 2.7, P = .0019).
The investigators concluded: “[Mirvetuximab soravtansine] did not seem to impair or improve patient quality of life compared with investigator’s choice of chemotherapy. The similar quality-of-life outcomes in the two treatment groups, combined with the previously reported higher efficacy of [mirvetuximab soravtansine] compared with single-agent chemotherapy, support [mirvetuximab soravtansine] as a new treatment option for FRα-positive platinum-resistant ovarian cancer.”
Felix Hilpert, MD, of Jerusalem Hospital, Hamburg, Germany, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by AbbVie. For full disclosures of the study authors, visit thelancet.com.
