Mirvetuximab soravtansine (IMGN853), an investigational antibody-drug conjugate, has been granted fast track designation by the U.S. Food and Drug Administration for the treatment of ovarian cancer patients, ImmunoGen, the therapy’s maker, announced.
The designation is for the treatment of ovarian cancer patients positive for folate receptor alpha (FRα), who aren’t responding to platinum-based chemotherapy, and for whom single-agent therapy is adequate as the next line of treatment.
It will support the development of mirvetuximab, speed its review and, depending on how it performs in clinical trials, expedite its entry into the market.
Mirvetuximab soravtansine is an investigational treatment for patients with FRα-positive cancer, including ovarian and endometrial cancer. It is an antibody-drug conjugate that targets FRα-positive cancer cells and kills them with a toxic compound called DM4.
“We are pleased the FDA has granted Fast Track designation for mirvetuximab soravtansine,” Mark Enyedy, ImmunoGen’s president and CEO, said in a press release. “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.”
Mirvetuximab is now being tested as a single agent for the treatment of ovarian, peritoneal, and fallopian tube cancer in a Phase 3 trial called FORWARD I (NCT02631876).
The trial is being conducted in North America and Europe and has completed enrollment of 333 women with epithelial ovarian cancer that expresses medium or high levels of FRα, whose cancer is resistant to platinum-based chemotherapy and who have received up to three prior lines of therapy.
Patients will be randomized to receive either mirvetuximab soravtansine or chemotherapy of the physician’s choice. The primary outcome will be the time it takes until disease progression or death, known as progression-free survival. Other outcome measures will be the proportion of patients with a reduction in tumor burden (objective response rate), overall survival, and quality of life.
Top-line results are expected in the first half of 2019, according to ImmunoGen.
Mirvetuximab soravtansine is also being evaluated in combination with other chemotherapies — Avastin (bevacizumab), Paraplatin (carboplatin), Doxil (pegylated liposomal doxorubicin), or Keytruda (pembrolizumab) — for both platinum-resistant and platinum-sensitive disease in a Phase 1b/2 trial, called FORWARD II (NCT02606305).
So far, results from the trial indicate that the combo therapy of mirvetuximab soravtansine with Avastin or Paraplatin shows promise for women with advanced ovarian cancer, particularly those who have received multiple prior lines of therapy.
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