05/15/2019 | Press release | Distributed by Public on 05/15/2019 09:40
ImmunoGen, Inc. (NASDAQ: IMGN). which develops antibody-drug conjugates targeting cancer, saw a strong downward move Wednesday after it announced the outcome of a Type C meeting held with the FDA last week regarding its ovarian cancer drug candidate.
The FDA has recommended conducting a new Phase 3 trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with high folate receptor alpha-positive, platinum-resistant ovarian cancer, ImmunoGen said Wednesday.
The company had requested the meeting with the FDA to discuss the Phase 3 study, dubbed FORWARD I, and a potential path for regulatory filing.
The FDA reasoned that, since the FORWARD I trial did not meet its primary endpoint under the prespecified statistical analysis plan, the data generated from the study's secondary endpoints cannot be used to support an accelerated approval.
The agency acknowledged that platinum-resistant ovarian cancer is a disease with an unmet need.
Mirvetuximab soravtansine is ImmunoGen's lead candidate and it is being evaluated in late and midstage studies for ovarian cancer, both as a monotherapy and combo treatments. The monotherapy trial is in the most advanced stages of clinical development.
An accelerated approval pathway allows approval of a drug meant to treat a serious condition with an unmet need based on a surrogate endpoint, thereby expediting the approval.
With the FDA providing guidance regarding the design and endpoints of a potential registration study, ImmunoGen now has to return to discuss a proposed study design.
'The mirvetuximab combination cohorts continue to advance and, with approximately $270 million on the balance sheet as of the end of Q1, we remain focused on developing innovative ADC therapeutics and delivering more good days to people with cancer,' ImmunoGen CEO Mark Enyedy said in a statement.
The company said it's also conducting an operational review of the business to extend its cash runway.
ImmunoGen shares were down 30.16 percent at $2.20 at the time of publication Wednesday.