Phase 3 Trial of Mirvetuximab Soravtansine in Ovarian Cancer OK’d to Continue as Planned

Phase 3 Trial of Mirvetuximab Soravtansine in Ovarian Cancer OK’d to Continue as Planned
A Phase 3 trial evaluating ImmunoGen’s mirvetuximab soravtansine (IMGN853) in platinum-resistant ovarian cancer patients is on its way to achieving its objectives, an interim futility analysis shows. As a result, the FORWARD I trial (NCT02631876) will continue as planned after an independent data monitoring committee recommended no changes. The trial has already completed patient recruitment, two months ahead of schedule. ImmunoGen now plans to release top-line data during the first half of 2019. “Ovarian cancer is the leading cause of death from gynecological cancers, and patients diagnosed with this life-threatening disease have limited treatment options, especially once they develop platinum-resistant disease,” Anna Berkenblit, MD, vice president and chief medical officer of ImmunoGen, said in a press release. “We are encouraged that the IDMC recommended FORWARD I proceed as planned and are pleased that the trial has reached full enrollment earlier than expected.” Mirvetuximab soravtansine is an antibody-drug conjugate targeting the folate receptor alpha (FRα). This means the drug combines an antibody against this receptor bound to a toxic compound. Once the antibody binds to a cell positive for FRα, it releases its payload, killing the cancer cell without harming healthy cells. It is estimated that approximately 60 percent of ovarian cancers have medium or high FRα expression. The U.S. Food and Drug Administration and the Euro
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