"Dosing the first patient in our Phase 3 FORWARD I study marks an
important milestone in our efforts to deliver mirvetuximab soravtansine
to patients in need and to drive innovation in the field of ADCs.
Mirvetuximab soravtansine has the potential to meaningfully improve the
lives of patients with platinum-resistant ovarian cancer, and our top
priority is advancing this program as quickly as possible," said
"Given the prognosis for most patients with platinum-resistant ovarian
cancer is poor and the benefit of approved agents is modest, we need
better therapies that offer improved outcomes in terms of efficacy and
FORWARD I is a Phase 3 trial in which 333 patients will be randomized
2:1 to receive either mirvetuximab soravtansine or the physician's
choice of single-agent chemotherapy (pegylated liposomal doxorubicin,
topotecan, or weekly paclitaxel). Eligible patients will have been
diagnosed with platinum-resistant ovarian cancer that expresses medium
or high levels of FRα and will have been treated with up to three prior
regimens. The primary endpoint of this study is progression free
survival (PFS), which will be assessed in the entire study population
and in the subset of patients with high FRα expression. ImmunoGen
estimates that 12,000-14,000 patients per year in the
ImmunoGen is partnering with the
About Mirvetuximab Soravtansine
Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting ADC. It uses a 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.
Mirvetuximab soravtansine is ImmunoGen's lead program and is now in Phase 3 testing as a single agent for the treatment of platinum-resistant ovarian cancer. The candidate is also being assessed in combination regimens for both platinum-resistant and platinum-sensitive disease in Phase 1b/2 FORWARD II trial.
About Ovarian Cancer and FRα
It is estimated that 23,000 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 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 19,000-24,000 women 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 a clinical-stage biotechnology company that develops targeted cancer therapeutics using its proprietary ADC technology. ImmunoGen's lead product candidate, mirvetuximab soravtansine, is in a Phase 3 trial for FRα-positive platinum-resistant ovarian cancer, and is in Phase 1b/2 testing in combination regimens for earlier-stage disease. ImmunoGen's ADC technology is used in Roche's marketed product, Kadcyla®, in three other clinical-stage ImmunoGen product candidates, and in programs in development by partners Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and Takeda. More information about the Company can be found at www.immunogen.com.
Kadcyla® and Avastin® are registered trademarks of
2Decision Resources Group Patientbase
This press release includes forward-looking statements. 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. It should be noted that there are risks and
uncertainties related to the development of novel anticancer products,
including mirvetuximab soravtansine, including risks related to
preclinical and clinical studies, their timings and results. A review of
these risks can be found in ImmunoGen's Annual Report on Form 10-K for
the fiscal year ended
FTI Consulting Inc.
Robert Stanislaro, 212-850-5657
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