ImmunoGen Announces Results from Mirvetuximab Soravtansine Phase 1 First-in-Human Dose-Escalation Trial Published in Cancer
May 01 2017 - 9:00AM
Business Wire
Data informed dosing in expansion cohorts and
Phase 3 FORWARD I registration trial
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced that the results from a Phase 1 dose-escalation
study evaluating mirvetuximab soravtansine (IMGN853) in patients
with folate receptor alpha (FRα)-positive solid tumors were
published in the journal Cancer. The previously disclosed data
demonstrated encouraging clinical activity and a manageable safety
profile for mirvetuximab soravtansine (IMGN853), and informed the
dose that was used in Phase 1 expansion cohorts and the ongoing
Phase 3 FORWARD I trial of patients with platinum-resistant ovarian
cancer.
“These Phase 1 results have played an important role in
determining the appropriate dose for mirvetuximab soravtansine in
the recently initiated Phase 3 FORWARD I trial of patients with
platinum-resistant ovarian cancer,” said Kathleen Moore, M.D.,
Associate Professor, Department of Obstetrics and Gynecology at the
Stephenson Cancer Center at the University of Oklahoma. “The
combination of these data and the recent data published in the
Journal of Clinical Oncology further support the dose that has been
chosen and patients who have been selected for FORWARD I.”
The open-label, Phase 1 dose-escalation study treated a total of
44 patients with recurrent ovarian (52%) or endometrial cancer
(25%), along with renal cell carcinoma and non-small cell lung
cancer (11% and 9%, respectively). Patients received mirvetuximab
soravtansine on day 1 of a 21-day cycle (Q3W dosing) with cycles
repeated until dose-limited toxicity or progression, concluding the
recommended dose for future trials is 6.0 mg/kg of mirvetuximab
(based on adjusted ideal body weight) dosed once every three weeks.
On the basis of the study findings, and additional data that
demonstrated the importance of FRα expression levels for optimal
mirvetuximab sorvatansine activity, the Company designed the Phase
3 FORWARD I trial utilizing this dose in patients with
platinum-resistant ovarian cancer, along with a Phase 1b trial
evaluating mirvetuximab in combination with standard-of-care
chemotherapy and targeted agents.1
Mirvetuximab soravtansine exhibited a manageable safety profile
and encouraging preliminary clinical activity. Adverse events (AEs)
were generally mild with the majority being grade 1 or grade 2
(least severe grades). The most commonly observed AEs were fatigue,
blurred vision and diarrhea.1
The publication, "Phase I dose-escalation study of mirvetuximab
soravtansine (IMGN853), a folate receptor alpha-targeting
antibody-drug conjugate, in patients with solid tumors,” is
available on the Cancer website.
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 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
In 2016, approximately 22,300 new cases of ovarian cancer will
be diagnosed in the U.S. and more than 14,200 women will
die from the disease.2 ImmunoGen estimates that 60% of ovarian
cancer cases have medium or high FRα expression.
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.
About ImmunoGen
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® is a registered trademark of Genentech, a
member of the Roche Group.
1Moore KN, et al: Phase I dose-escalation study of mirvetuximab
soravtansine (IMGN853), a folate receptor alpha-targeting
antibody-drug conjugate, in patients with solid tumors,
Cancer, 25 April 2017
2American Cancer Society, Cancer Facts & Figures 2016
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, and
risks related to clinical studies, their timing and results. A
review of these risks can be found in ImmunoGen's transition report
on Form 10-K for the six-month transition period ended December 31,
2016 and other reports filed with the Securities and Exchange
Commission.
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Investor ContactThrust IRMonique Allaire,
617-895-9511monique@thrustir.comorMedia ContactFTI
Consulting, Inc.Robert Stanislaro,
212-850-5657robert.stanislaro@fticonsulting.com
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