KEY TAKEAWAYS
- The MIRASOL phase III trial aimed to compare the efficacy and safety of MIRV with the investigator’s choice of chemotherapy in treating platinum-resistant, high-grade serous OC.
- The primary endpoint was PFS. Secondary analytic endpoints were OR, OS, and participant-reported outcomes.
- The study found that the treatment offered significantly better PFS, OS, and OR than chemotherapy.
Mirvetuximab soravtansine-gynx (MIRV), an innovative antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα), has received regulatory approval in the US for the treatment of ovarian cancer(OC) that has become resistant to platinum-based chemotherapy. This represents a significant advancement in the fight against this aggressive disease.
Researchers aimed to compare the efficacy and safety of MIRV with the investigator’s choice of chemotherapy in treating platinum-resistant, high-grade serous OC.
The study randomly(1:1) assigned previously treated with one to three lines of therapy and exhibiting high FRα tumor expression (≥75% of cells with ≥2+ staining intensity) to receive MIRV (6 mg per kilogram of adjusted ideal body weight every 3 weeks) or chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan).
The primary endpoint was investigator-assessed progression-free survival(PFS). Secondary analytic endpoints were objective response(OR), overall survival(OS), and participant-reported outcomes.
About 453 patients underwent randomization, with 227 assigned to the MIRV group and 226 to the chemotherapy group. The median PFS was 5.62 months (95% CI, 4.34 to 5.95) with MIRV and 3.98 months (95% CI, 2.86 to 4.47) with chemotherapy (P<0.001). In the MIRV group, 42.3% achieved an OR, compared to 15.9% in the chemotherapy group (OR, 3.81; 95% CI, 2.44 to 5.94; P<0.001).
OS was significantly longer with MIRV than with chemotherapy (median, 16.46 months vs. 12.75 months; HR for death, 0.67; 95% CI, 0.50 to 0.89; P=0.005). During the treatment period, MIRV demonstrated fewer adverse events(AEs) of grade 3 or higher compared to chemotherapy (41.7% vs. 54.1%), as well as fewer serious AEs of any grade (23.9% vs. 32.9%) and events leading to discontinuation (9.2% vs. 15.9%).
The study found that the treatment offered significantly better PFS and OS, as well as OR, than chemotherapy.
Clinical Trial: https://clinicaltrials.gov/study/NCT04209855
Moore KN, Angelergues A, Konecny GE, García Y, Banerjee S, Lorusso D, Lee JY, Moroney JW, Colombo N, Roszak A, Tromp J, Myers T, et al. Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer. The New England Journal of Medicine
