Treatment Response to ImmunoGen’s Mirvetuximab Soravtansine Found to be Substantially Greater in Ovarian Cancer with High E...
November 08 2015 - 12:30PM
Business Wire
- Objective response on mirvetuximab
soravtansine in nine of ten (90%) patients with high amounts of
target on cancer cells; majority of these responders remained on
treatment for at least 24 weeks
- Most patients with ovarian cancer found
to have high or medium expression of target
- FORWARD I ovarian cancer trial on track
to begin in late 2015 – intended to support potential Accelerated
Approval pathway
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that
develops targeted anticancer therapeutics using its antibody-drug
conjugate (ADC) technology, today reported findings with
mirvetuximab soravtansine, its novel folate receptor alpha
(FRα)-targeting ADC product candidate, being presented at the
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics (abstract #C47). Analysis of the association
between the amount of FRα present on patient cancer cells and
response to treatment with mirvetuximab soravtansine found nine of
ten (90%) patients with high levels of FRα had an objective
response on treatment.
“These early findings are highly encouraging as they underscore
the potential of mirvetuximab soravtansine to make an important
difference for patients with ovarian cancer,” said Dr. Charles
Morris, chief development officer. “The data are from patients with
heavily pretreated platinum-resistant ovarian cancer, which is a
difficult disease to treat. We will be assessing mirvetuximab
soravtansine as single-agent therapy for patients with pretreated
FRα-positive ovarian cancer in our FORWARD I trial, a study we
intend to use for registration purposes.”
The findings presented today are from an analysis of 20
efficacy-evaluable patients with platinum-resistant ovarian cancer
who received mirvetuximab soravtansine in Phase 1 testing at its
selected dose. Patients were categorized as having high, medium or
low amounts of FRα on their cancer cells.1 Enrollment criteria for
the clinical study required all patients to have at least low
expression.
- Nine of the ten patients with high FRα
expression had an objective response (2 complete
responses/CRs, 7 partial responses/PRs by RECIST 1.1 criteria). Six
of these responders remained on treatment for at least 24
weeks.
- The six patients with medium expression
all had tumor regression. One patient had an objective response
(unconfirmed PR) and one had tumor shrinkage with new lesion
formation (mixed response/MR). An additional patient remained on
treatment for more than six months but did not have an objective
response.
- Four patients had low expression and
none had an objective response. One patient was still on treatment
at the time of data cut off for presentation.
The ORR was 50% for all 20 efficacy-evaluable patients. Among
all 22 patients evaluable for tolerability, the majority of adverse
events reported were low grade (grade 1 or 2), with diarrhea,
blurred vision, vomiting, fatigue, and nausea the most common
treatment-emergent events reported (>30% of patients).
ImmunoGen anticipates reporting mature data from the full
46-patient cohort in this study at a medical meeting in 2016.
The FORWARD I Trial
ImmunoGen’s FORWARD I trial will assess mirvetuximab
soravtansine as single-agent therapy for the treatment of ovarian
cancer previously treated with three to four prior regimens.
Patients will have medium or high expression of FRα to qualify for
enrollment in this Phase 2 study. Patient enrollment is expected to
start in late 2015.
About Mirvetuximab Soravtansine
Mirvetuximab soravtansine (IMGN853) is a FRα-targeting ADC
developed and wholly owned by ImmunoGen. It comprises a FRα-binding
antibody conjugated to DM4, a potent cancer-killing agent created
by ImmunoGen for use in ADCs. The antibody serves to target the DM4
specifically to FRα-positive cancer cells which the DM4 can then
kill. FRα is highly expressed on many cases of epithelial ovarian
cancer.2 It also is highly expressed on other types of solid tumors
including endometrial cancer and some non-small cell lung
cancers.
About Ovarian Cancer
Each year, there are approximately 21,300 new cases of ovarian
cancer diagnosed in the US and more than 14,200 women die from the
disease.3 Once the cancer has been treated with several lines of
combination regimens, patients may be treated with single-agent
therapy, which typically have response rates around 15-20%.4
About ImmunoGen, Inc.
ImmunoGen is a clinical-stage biotechnology company that
develops targeted anticancer therapeutics using its proprietary ADC
technology. The Company's lead wholly owned product candidate,
mirvetuximab soravtansine, is a potential treatment for
FRα-positive ovarian cancers and other solid tumors. Major
healthcare companies have licensed rights to use ImmunoGen's
technology to develop novel anticancer therapies; Roche's marketed
product, Kadcyla®, utilizes ImmunoGen's ADC technology. More
information about the Company can be found at
www.immunogen.com.
1High, medium, low: >75%, 50-74%, and 25-49%, respectively,
of tumor cells have strong (3+) or moderate (2+) expression of FRα,
as assessed by immunohistochemistry (IHC), a standard method of
target measurement for antibody-based therapeutics.
2AACR 2015 abstract #3400A.
3American Cancer Society (2015), Cancer Facts &
Figures.
4From prescribing information and published clinical data.
Kadcyla® is a registered trademark of Genentech, a member of the
Roche Group.
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
(IMGN853), including risks related to clinical studies and
regulatory processes, 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, 2015 and other reports filed with
the Securities and Exchange Commission.
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version on businesswire.com: http://www.businesswire.com/news/home/20151108005018/en/
For Investors:ImmunoGen, Inc.Carol Hausner,
781-895-0600info@immunogen.comorFor Media:Michael Lampe,
484-575-5040michael@michaellampeconsulting.com
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