Kathleen N. Moore, MD from OU Medicine discusses an ASCO 2020 abstract entitled MIRASOL (GOG 3045/ENGOT OV-55): A randomized, open-label, phase III study of mirvetuximab soravtansine versus investigator"™s choice of chemotherapy in advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate-alpha (FRα) expression.
Bottom line:
Elevated expression of FRα is a feature of many solid tumors, including epithelial ovarian cancer (EOC) and thus provides an attractive candidate for targeted therapeutic approaches. Mirvetuximab soravtansine is an antibody-drug conjugate (ADC) comprising a FRα-binding antibody, cleavable linker, and the maytansinoid DM4, a potent tubulin-targeting agent that has shown consistent and meaningful single agent clinical activity, along with favorable tolerability, in patients with high FRα expressing tumors.
Approaches:
MIRASOL is a randomized phase III trial designed to test the efficacy of mirvetuximab soravtansine in adult patients with platinum-resistant EOC, primary peritoneal or fallopian tube cancer, compared with standard chemotherapy. Inclusion requires evidence of high FRα positivity by immunohistochemistry (high expression; approximately 75 percent of PS2 + staining strength cells) and approximately 3 prior therapy lines. MIRASOL is intended to randomize 430 patients to either Arm 1:1 (6 mg / kg dose of intravenous mirvetuximab soravtansine, measured using modified ideal body weight on Day 1 of the 21-day cycle) or Arm 2 (chemotherapy of choice for investigators: paclitaxel, pegylated liposomal doxorubicin, or topotecan). The primary endpoint of effectiveness is progression-free survival (PFS; by investigator), and the secondary endpoints include objective response time, quality of life, overall survival, and protection and tolerability. In December 2019 MIRASOL opened for enrollment. Details on clinical trials: NCT04209855