ImmunoGen Announces First Patient Dosed in FORWARD I Phase 3 Study of Mirvetuximab Soravtansine in Platinum-Resistant Ovarian...
January 26 2017 - 4:01PM
Business Wire
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced that the first patient has been dosed in FORWARD I,
the Company’s Phase 3 clinical trial evaluating mirvetuximab
soravtansine as a single-agent therapy for the treatment of
platinum-resistant ovarian cancer. Mirvetuximab soravtansine is a
first-in-class, folate receptor alpha (FRα)-targeting ADC.
“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 Anna Berkenblit, M.D., Vice President
and Chief Medical Officer of ImmunoGen.
“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 tolerability,” said Kathleen Moore, M.D.,
FORWARD I Co-Principal Investigator, and Associate Professor,
Stephenson Cancer Center, University of Oklahoma. “We are
excited about the potential of mirvetuximab soravtansine and are
looking forward to evaluating this promising agent in a pivotal
study.”
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 U.S. meet these criteria,
with a comparable number in the major markets in Europe.
ImmunoGen is partnering with the GOG 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
soravtansine for patients with platinum-resistant ovarian
cancer.
About Mirvetuximab SoravtansineMirvetuximab 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 FRαIt 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.
About ImmunoGenImmunoGen 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 Genentech, a
member of the Roche Group.
1American Cancer Society, Cancer Facts & Figures
20162Decision 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
June 30, 2016 and other reports filed with the Securities and
Exchange Commission.
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Investor Contact:ImmunoGen, Inc.Sarah Kiely,
781-895-0600sarah.kiely@immunogen.comorMedia
Contacts:ImmunoGen, Inc.Amy Reilly,
781-895-0138amy.reilly@immunogen.comorFTI Consulting Inc.Robert
Stanislaro, 212-850-5657robert.stanislaro@fticonsulting.com
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