Pivotal Trial of Mirvetuximab Soravtansine in Advanced Ovarian Cancer Levels Likely in 2020

Pivotal Trial of Mirvetuximab Soravtansine in Advanced Ovarian Cancer Levels Likely in 2020
ImmunoGen is planning to open an open-label, pivotal clinical trial of mirvetuximab soravtansine in platinum-resistant ovarian cancer patients with high levels of the folate receptor alpha (FRα) protein early next year, the company announced. Results could lead to the treatment's accelerated, and conditional, approval by the U.S. Food and Drug Administration (FDA), the company announced in a press release. To be called SORAYA, the trial will enroll about 100 patients previously given one to three therapies, including bevacizumab. It will enroll concurrently with a longer and larger Phase 3 trial in a similar patient group, called MIRASOL, that will serve as a confirmatory study. "We have engaged in constructive discussions with FDA and evaluated all avenues to bring mirvetuximab to patients more quickly," Mark Enyedy, the president and CEO of ImmunoGen, said in the release. If SORAYA's results support the treatment's efficacy, it "would enable us to submit an application for accelerated approval during the second half of 2021." Mirvetuximab soravtansine is an antibody-drug conjugate (ADC), meaning it consists of an antibody bound to a cell-killing agent. When the antibody binds to its target — the folate receptor alpha (FRα), a protein found at medium-to-high levels in about 60% of ovarian cancers — it releases the toxic compound, killing the cancer cell without harming healthy cells. The i
Subscribe or to access all post and page content.