Data Confirm Use of Archival Tumor Tissue to
Determine Patient Selection in FORWARD I
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced that data from a mirvetuximab soravtansine
(IMGN853) Phase 1 biopsy expansion cohort demonstrate that archival
tumor tissue can reliably identify patients with folate receptor
alpha (FRα)-positive platinum-resistant ovarian cancer. These data
will be presented at the Society of Gynecologic Oncology (SGO)
Annual Meeting, which is being held March 12-15 in National Harbor,
MD.
“In the Phase 3 FORWARD I registration trial for mirvetuximab
soravtansine, FRα expression for patient selection is being
assessed based on archival tumor tissue samples,” said Anna
Berkenblit, M.D., Vice President and Chief Medical Officer of
ImmunoGen. “The results being presented at SGO support this
strategy to select patients for our Phase 3 FORWARD I trial. More
broadly, the data being presented confirm that in this heavily
pretreated cohort, mirvetuximab soravtansine is well tolerated and
that the higher the FRα expression, the greater the anti-tumor
activity.”
The objectives of the biopsy expansion cohort were to:
- Characterize FRα expression in archival
tumor tissue and in pre- and post-treatment biopsy samples obtained
from a heterogeneous population of relapsed epithelial ovarian
cancer (EOC) patients;
- Determine the concordance rate between
archival tissue and pre-treatment biopsy FRα expression levels;
and
- Compare changes in FRα expression
levels before and after treatment with mirvetuximab soravtansine in
biopsy samples.
In the biopsy expansion cohort, a total of 27 heavily pretreated
patients (including patients with up to 11 prior therapies) were
enrolled based on FRα expression levels in archival tumor tissue.
Patients underwent a pre-treatment biopsy prior to receiving
mirvetuximab soravtansine and a post-treatment biopsy after two
doses of mirvetuximab soravtansine.
A comparison of FRα levels in pre-treatment biopsies versus
archival samples supports the use of archival tumor tissue for
patient selection. Of the 21 evaluable pre-treatment samples, 15
met the eligibility criterion for the biopsy expansion cohort (≥
25% cells with ≥ 2+ intensity), resulting in a 71% concordance with
archival tumor tissues. Twenty-two percent (22%) of patients (6/27)
did not have pre-treatment biopsies evaluable for FRα
immunohistochemistry due to insufficient tumor cells present in the
specimens. Additionally, biopsies taken prior to and following two
doses of mirvetuximab soravtansine showed similar FRα expression
levels. The findings also support the use of a pre-treatment biopsy
for patient selection if archival tumor tissue is not available for
evaluation.
The safety profile of the cohort was consistent with that
previously reported for mirvetuximab soravtansine-treated EOC
patients across the Phase 1 study, with predominately Grade 1 and 2
adverse events. Based on FRα expression in both archival and
pre-treatment biopsies, the data also demonstrated that anti-tumor
activity increased with higher FRα expression levels.
Presentation
Title: “Characterization of folate receptor alpha (FRα)
expression in archival tumor and biopsy samples in a phase I study
of mirvetuximab soravtansine, a FRα-targeting antibody-drug
conjugate (ADC), in relapsed epithelial ovarian cancer patients”
(abstract #61)
The findings will be presented during featured poster
presentation discussion sessions:
- Monday, March 13, 3:30-5:00pm ET
- Tuesday, March 14, 3:30-4:30pm ET
Additional information can be found at www.sgo.org.
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 (the FORWARD I trial) 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 FORWARD I
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 Ovarian Cancer and FRα
It is estimated that 22,500 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 ImmunoGen, Inc.
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.
1American Cancer Society, Cancer Facts & Figures
20172Decision 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, 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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version on businesswire.com: http://www.businesswire.com/news/home/20170312005013/en/
Investor ContactImmunoGen, Inc.Sarah Kiely,
781-895-0600sarah.kiely@immunogen.comorMedia ContactFTI
Consulting, Inc.Robert Stanislaro,
212-850-5657robert.stanislaro@fticonsulting.com
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