ImmunoGen to Pursue BLA for Therapy Attacking Hard-to-Treat Ovarian Cancer

Armed with strong results from a late-stage clinical trial, ImmunoGen plans to submit a new Biologics License Application (BLA) for its drug/antibody conjugate Mirvetuximab (mirvetuximab soravtansine) as a treatment for women with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Roche’s Avastin (bevacizumab).

The company is counting on positive phase 3 trial data to impress regulators, ImmunoGen executives said in an investor webcast this week.

The single-armed study tested Mirvetuximab in 106 patients with platinum-resistant high-grade epithelial ovarian, primary peritoneal or fallopian tube cancer, whose tumors express a high-level of FRα. All participants had failed one to four lines of prior therapy, including standard-of-care bevacizumab and poly-adenosine diphosphate-ribose polymerase (PARP) inhibitor treatment.

At a median follow-up of eight months, Mirvetuximab conferred an overall response rate of 32.4 percent. This included five complete responses — an almost unheard-of result for women with this very difficult cancer, said Robert Coleman, a primary investigator on the Soraya trial.