ImmunoGen Announces Successful Completion of Interim Analysis for FORWARD I Phase 3 Trial of Mirvetuximab Soravtansine in Pla...
April 26 2018 - 4:01PM
Business Wire
FORWARD I trial has completed full enrolloment;
top-line results expected in the first half of 2019
ImmunoGen, Inc. (Nasdaq: IMGN), a
leader in the expanding field of antibody-drug conjugates (ADCs)
for the treatment of cancer, today announced that the FORWARD
I Phase 3 registration trial evaluating mirvetuximab soravtansine
as a single-agent therapy for the treatment of platinum-resistant
ovarian cancer will continue as planned without modification. The
decision follows a recommendation by the Independent Data
Monitoring Committee (IDMC) based upon successful completion of a
pre-specified interim futility analysis after 80 progression-free
survival (PFS) events as determined by blinded, independent central
review. ImmunoGen has also completed full enrollment of the trial
two months ahead of schedule and expects top-line results from
FORWARD I during the first half of 2019.
“Ovarian cancer is the leading cause of death from gynecological
cancers, and patients diagnosed with this life-threatening disease
have limited treatment options, especially once they develop
platinum-resistant disease,” said Anna Berkenblit, M.D., vice
president and chief medical officer of ImmunoGen. “We are
encouraged that the IDMC recommended FORWARD I proceed as planned
and are pleased that the trial has reached full enrollment earlier
than expected. We look forward to assessing top-line data in the
first half of 2019.”
FORWARD I is an ongoing Phase 3 trial designed to randomize 333
patients 2:1 to receive either mirvetuximab soravtansine or the
physician's choice of single-agent chemotherapy (pegylated
liposomal doxorubicin, topotecan, or weekly paclitaxel).
Eligibility criteria include patients with platinum-resistant
ovarian cancer that express medium or high levels of folate
receptor alpha (FRα) who have been treated with up to three prior
regimens. The primary endpoint of this study is PFS, which is being
assessed in the entire study population and in the subset of
patients with high FRα expression. Enrollment was initially planned
to be completed by the end of June.
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 soravtansine for patients with
platinum-resistant ovarian cancer.
About Mirvetuximab SoravtansineMirvetuximab soravtansine
(IMGN853) is the first 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 these targeted cancer cells.
Mirvetuximab is also being assessed in combination regimens for
both platinum-resistant and platinum-sensitive disease in the Phase
1b/2 FORWARD II trial.
About Ovarian Cancer and FRαIt 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.
About ImmunoGen, Inc.ImmunoGen is a clinical-stage
biotechnology company that develops targeted cancer therapeutics
using its proprietary ADC technology. The Company’s lead product
candidate, mirvetuximab soravtansine, is in the FORWARD I Phase 3
trial for FRα-positive platinum-resistant ovarian cancer, and is in
the FORWARD II Phase 1b/2 trial in combination regimens for
earlier-stage disease. ImmunoGen has three additional
clinical-stage product candidates, two of which are being developed
in collaboration with Jazz Pharmaceuticals. ImmunoGen's ADC
technology is also used in Roche's marketed product, Kadcyla®, and
in programs in development by Amgen, Bayer, Biotest, CytomX,
Debiopharm, Lilly, Novartis, Sanofi and Takeda. More information
about the Company can be found at www.immunogen.com.
Kadcyla® is a registered trademark of Genentech, a member of the
Roche Group.
1American Cancer Society. Cancer Facts & Figures 2018.
Atlanta, Ga: American Cancer Society; 2018.
2Decision Resources Group Patientbase.
This press release includes forward-looking statements,
including statements related to the expected timing of results. 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 year
ended December 31, 2017 and other reports filed with
the Securities and Exchange Commission.
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For InvestorsImmunoGen, Inc.Sarah Kiely,
781-895-0600sarah.kiely@immunogen.comorFor MediaImmunoGen,
Inc.Courtney O'Konek,
781-895-0600courtney.okonek@immunogen.comorFTI Consulting,
Inc.Robert Stanislaro,
212-850-5657robert.stanislaro@fticonsulting.com
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