ImmunoGen Announces FDA Fast Track Designation for Mirvetuximab Soravtansine in Patients with Platinum-Resistant Ovarian Cancer
“We are pleased the
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
ImmunoGen is partnering with the
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.
About Mirvetuximab Soravtansine
Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.
About Ovarian Cancer and FRα
It is estimated that 22,000 women are diagnosed annually with ovarian cancer in the US. With more than 14,000 deaths each year, ovarian cancer accounts for more deaths than any other cancer of the female reproductive system.1
Standard first-line therapy for ovarian cancer is a platinum-based combination regimen. Once the cancer becomes platinum-resistant, treatment options include single-agent cytotoxic therapies such as pegylated liposomal doxorubicin, paclitaxel, or topotecan, and combination therapies that include Avastin.
There is a significant need for more effective, better-tolerated therapies for recurrent ovarian cancer. It is estimated that approximately 19,000 women in the US and approximately 24,000 women in the EU have platinum-resistant ovarian cancer requiring second-line or later treatment.2 ImmunoGen estimates that 60% of ovarian cancer cases have medium or high FRα expression.
ImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to “target a better now.” Our lead product candidate, mirvetuximab soravtansine, is in Phase 3 study for folate receptor alpha (FRα)-positive platinum resistant ovarian cancer, and in Phase 1b/2 testing in combination regimens. Our novel IGN candidates for hematologic malignancies, IMGN779 and IMGN632, are in Phase 1 studies. Learn more about who we are, what we do, and how we do it at www.immunogen.com.
Keytruda® and Avastin® are registered trademarks of their respective owners.
2 Decision Resources Group Patientbase.
This press release includes forward-looking statements based on
management's current expectations. These statements include, but are not
limited to, ImmunoGen's ability to expand the addressable patient
population for mirvetuximab soravtansine and the regulatory and
commercial potential of mirvetuximab combinations in earlier lines of
therapy. For these statements, ImmunoGen claims the protection of the
safe harbor for forward-looking statements provided by the Private
Securities Litigation Reform Act of 1995. Various factors could cause
ImmunoGen's actual results to differ materially from those discussed or
implied in the forward-looking statements, and you are cautioned not to
place undue reliance on these forward-looking statements, which are
current only as of the date of this release. It should be noted that
there are risks and uncertainties related to the development of novel
anticancer products, including risks related to preclinical and clinical
studies, their timings and results, and the potential that earlier
clinical studies may not be predictive of future results. A review of
these risks can be found in ImmunoGen's Annual Report on Form 10-K for
the year ended
Sarah Kiely, 781-895-0600
Courtney O’Konek, 781-895-0600
Robert Stanislaro, 212-850-5657