Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent to kill the targeted cancer cells.
The US Food and Drug Administration (FDA) granted orphan drug designation to mirvetuximab for the treatment of ovarian cancer; mirvetuximab has also received this designation in the EU. In June 2018, the FDA granted mirvetuximab Fast Track designation for the treatment of patients with medium to high FRα-positive platinum-resistant ovarian cancer who received at least one, but no more than three prior systemic treatment regimens, and for whom single-agent chemotherapy is appropriate as the next line of therapy. This designation is intended to facilitate the development and expedite the review of drugs to treat serious and life-threatening conditions.
In December 2019, the Company (ImmunoGen) announced that FDA advised that a new single-arm study in platinum-resistant ovarian cancer could support accelerated approval for mirvetuximab. Based on this guidance, the Company initiated SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in women with FRα-high platinum-resistant ovarian cancer who have been previously treated with Avastin® (bevacizumab). The Company is concurrently enrolling MIRASOL, the Phase 3 randomized confirmatory study of mirvetuximab in patients with FRα-high platinum-resistant ovarian cancer who have been treated with up to three prior regimens. Mirvetuximab is also being studied in combination.
For more information on mirvetuximab clinical trials, visit www.clinicaltrials.gov.
Visit our Publications page to access mirvetuximab data presentations from past medical meetings.