Positive Results Form Basis for FORWARD I
Phase 3 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 results from the Phase 1 expansion cohort
evaluating mirvetuximab soravtansine (IMGN853) in patients with
folate receptor alpha (FRα)-positive platinum-resistant ovarian
cancer were published in the Journal of Clinical Oncology. The data
demonstrate the potential clinical benefit of mirvetuximab
soravtansine for the treatment of platinum-resistant ovarian
cancer.
“Standard single-agent therapy for patients with
platinum-resistant ovarian cancer typically has a response rate
below 20% and median progression-free survival below four months,”
said Kathleen Moore, M.D., Associate Professor, Stephenson Cancer
Center, University of Oklahoma, and lead author of the
publication. “Mirvetuximab soravtansine generated encouraging
efficacy and tolerability data in the Phase 1 trial that suggest
the potential to improve clinical outcomes for this patient
population.”
The Phase 1 expansion cohort enrolled 46 patients with
platinum-resistant epithelial ovarian, fallopian tube, or primary
peritoneal cancer whose tumors were positive for FRα. Patients were
dosed with mirvetuximab soravtansine once every three weeks.
Mirvetuximab soravtansine demonstrated single-agent activity in the
46-patient cohort with a 26% confirmed response rate and median
progression free survival (PFS) of 4.8 months. In a subset of 23
patients with low, medium or high FRα, who had received three or
fewer prior lines of therapy, there was a 39% objective response
rate (ORR) and median PFS of 6.7 months. On the basis of the study
findings and additional data demonstrating the importance of FRα
expression levels with mirvetuximab soravtansine, the Company has
designed the Phase 3 FORWARD I study to enroll patients with
platinum-resistant ovarian cancer with one to three prior therapies
and with medium or high FRα. This group of patients in the Phase 1
expansion cohort exhibited a 44% ORR and a median PFS of 6.7
months.1
Mirvetuximab soravtansine exhibited a manageable safety profile.
Adverse events (AEs) were generally mild with the majority being
grade 1 or grade 2 (least severe grades). The most commonly
observed AEs were diarrhea, blurred vision, nausea, and
fatigue.
“These results demonstrate that mirvetuximab soravtansine is
active in platinum-resistant ovarian cancer, with encouraging
response rates and progression-free survival combined with a
manageable safety profile,” said Anna Berkenblit, M.D., Vice
President and Chief Medical Officer of ImmunoGen. “On the basis of
these findings, we have moved confidently into a Phase 3
registration study evaluating this promising agent against the
standard of care in the platinum-resistant setting. In addition, we
are evaluating combination regimens to assess mirvetuximab
soravtansine in expanded patient populations and will begin
reporting data from these combinations in mid-2017.”
The publication, “Safety and Activity of Mirvetuximab
Soravtansine (IMGN853), a Folate Receptor Alpha-Targeting
Antibody-Drug Conjugate, in Platinum-Resistant Ovarian, Fallopian
Tube, or Primary Peritoneal Cancer: A Phase I Expansion Study,” is
available on the Journal of Clinical Oncology 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 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
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, Martin LP, Matulonis UA et al: IMGN853 (mirvetuximab
soravtansine), a folate receptor alpha (FRα)-targeting
antibody-drug conjugate (ADC): single-agent activity in
platinum-resistant epithelial ovarian cancer (EOC) patients,
presented at American Society of Clinical Oncology, June 2016,
abstract # 5567
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,
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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version on businesswire.com: http://www.businesswire.com/news/home/20161228005274/en/
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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