ImmunoGen Announces FDA Fast Track Designation for Mirvetuximab Soravtansine in Patients with Platinum-Resistant Ovarian Cancer

ImmunoGen, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its lead program, mirvetuximab soravtansine. The designation is for the treatment of patients with medium to high folate receptor alpha (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.

“We are pleased the FDA has granted Fast Track designation for mirvetuximab soravtansine,” said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. “Patients with platinum-resistant ovarian cancer have a poor prognosis and we are encouraged by the FDA’s recognition of the significant need for new therapeutic options that may be addressed by mirvetuximab as monotherapy. This important designation is based on the promising safety and activity findings observed to-date and we look forward to working closely with the FDA as we advance the development of mirvetuximab.”

The FDA’s Fast Track Designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously.

Mirvetuximab soravtansine is being evaluated in the FORWARD I Phase 3 trial. The trial is designed to randomize 333 patients 2:1 to receive either mirvetuximab soravtansine or the physician’s choice of single-agent chemotherapy. Eligibility criteria include patients with platinum-resistant ovarian cancer that express medium or high levels of FRα who have been treated with up to three prior regimens. The primary endpoint of this study is Progression Free Survival, which is being assessed in the entire study population and in the subset of patients with high FRα expression. Enrollment of FORWARD I was completed ahead of schedule in April 2018 and ImmunoGen expects to report top-line results from the FORWARD I trial in the first half of 2019.

ImmunoGen is partnering with the Gynecologic Oncology Group Foundation Inc., a leader in clinical research in gynecologic malignancies, on FORWARD I, which is being conducted in North America and Europe. This trial is intended to support full marketing approval of mirvetuximab for patients with platinum-resistant ovarian cancer.

Mirvetuximab soravtansine is also being assessed in multiple combinations in the FORWARD II trial. FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), or Keytruda (pembrolizumab) in patients with FRα-positive platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube tumors, as well as a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.