ImmunoGen Presents Initial Data from Phase 1b FORWARD II Triplet Cohort Evaluating Mirvetuximab Soravtansine in Combination w...
September 29 2019 - 5:01AM
Business Wire
FORWARD II Triplet Combination Demonstrates Encouraging
Anti-Tumor Activity
Preliminary Findings Support Ongoing Study in Platinum-Sensitive
Patients
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced initial safety and overall response data from the
Phase 1b FORWARD II triplet cohort evaluating mirvetuximab in
combination with carboplatin and Avastin® (bevacizumab) in patients
with recurrent, platinum-sensitive ovarian cancer at the European
Society for Medical Oncology (ESMO) 2019 Congress in Barcelona,
Spain.
“The initial results from the triplet combining mirvetuximab
with both bevacizumab and carboplatin build nicely off of the
encouraging data previously generated when mirvetuximab was paired
individually with each of these agents,” said David O'Malley, M.D.,
Professor, Director of Gynecologic Oncology and Co-Director,
Gynecologic Oncology Phase 1 Program at The Ohio State University
and the James Cancer Center, and FORWARD II Principal Investigator.
“The anti-tumor responses observed with this combination compare
favorably to those of other triplets and I look forward to
reporting longer-term efficacy data, as we seek to provide new
treatment options for patients with recurrent, FRα-positive
platinum-sensitive ovarian cancer.”
Key Findings from FORWARD II Triplet Cohort
- In 41 patients with recurrent platinum-sensitive disease with
medium or high folate receptor alpha (FRα) expression levels who
have received up to two prior lines of therapy, the confirmed
overall response rate (ORR) for the triplet was 83%, with a
complete response (CR) rate of 17%.
- In a subset of 31 patients with only 1 prior line, the
confirmed ORR was 90%, with a CR rate of 19%.
- These efficacy outcomes are encouraging relative to those
reported in similar patient populations for other carboplatin and
bevacizumab-based triplets.
- With a median follow up of 9.3 months, progression-free
survival (PFS) data are maturing.
- The combination of full dose mirvetuximab, carboplatin and
bevacizumab is well tolerated.
- No new safety signals were seen; adverse events observed with
the triplet were as expected based on the side effect profiles of
each agent, with thrombocytopenia as the most common cause of
drug-related discontinuations.
- Post-carboplatin (median 6 cycles), mirvetuximab and
bevacizumab continuation/maintenance is well tolerated.
“We are encouraged by the initial safety and overall response
data from our triplet cohort, demonstrating that full-dose
mirvetuximab can be combined safely with the standard dosing for
both bevacizumab and carboplatin,” said Anna Berkenblit, M.D., Vice
President and Chief Medical Officer of ImmunoGen. “We are
continuing to follow patients for progression-free survival and
look forward to initiating the next set of studies to support a
path to registration in platinum-sensitive ovarian cancer.”
ESMO Poster Details
- Title: “Mirvetuximab soravtansine, a folate receptor
alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination
with carboplatin and bevacizumab: Initial results from a Phase 1b
study in patients with ovarian cancer” (Abstract #1028P)
- Date: Sunday, September 29, 2019
- Time: 12:00 p.m. CEST/6:00 a.m. ET
- Lead Author: David M. O’Malley M.D., James Comprehensive
Cancer Center, The Ohio State University, Columbus, OH
Additional information can be found at www.esmo.org.
ABOUT MIRVETUXIMAB SORAVTANSINE Mirvetuximab soravtansine
(IMGN853) is the first folate receptor alpha (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 the targeted cancer cells.
ABOUT FORWARD II FORWARD II is a Phase 1b/2 study of
mirvetuximab soravtansine in combination with AVASTIN®
(bevacizumab) in patients with platinum-resistant ovarian cancer
that express medium or high levels of FRα as well as a triplet
combination of mirvetuximab plus carboplatin and bevacizumab in
patients with platinum-sensitive ovarian cancer that express medium
or high levels of FRα.
ABOUT IMMUNOGEN ImmunoGen is developing the next
generation of antibody-drug conjugates (ADCs) to improve outcomes
for cancer patients. By generating targeted therapies with enhanced
anti-tumor activity and favorable tolerability profiles, we aim to
disrupt the progression of cancer and offer our patients more good
days. We call this our commitment to “target a better now.”
Learn more about who we are, what we do, and how we do it at
www.immunogen.com.
AVASTIN® is a registered trademark of Genentech, Inc.
This press release includes forward-looking statements based on
management's current expectations. These statements include, but
are not limited to, ImmunoGen’s expectations related to: obtaining
PFS data for the triplet cohort and the initiation of the next
studies to support a path to registration of the triplet therapy in
platinum-sensitive ovarian cancer. 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. Various factors could cause ImmunoGen’s actual results to
differ materially from those discussed or implied in the
forward-looking statements, and you are cautioned not to place
undue reliance on these forward-looking statements, which are
current only as of the date of this release. Factors that could
cause future results to differ materially from such expectations
include, but are not limited to: the timing and results of
communications with FDA, risks and uncertainties related to the
execution of the restructuring of the Company’s operations, the
Company’s ability to control future spending and raise additional
funds to enable it to fund its continuing operations through the
release of top-line results from the planned mirvetuximab pivotal
study, the possibility that futures studies fail to replicate the
data indicated in the exploratory analyses of the FORWARD I data,
and the risks and uncertainties inherent in the Company’s
development programs, including 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 year
ended December 31, 2018 and other reports filed with the Securities
and Exchange Commission.
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INVESTOR RELATIONS AND MEDIA ImmunoGen Courtney O’Konek
781-895-0600 courtney.okonek@immunogen.com OR FTI Consulting
Robert Stanislaro 212-850-5657
robert.stanislaro@fticonsulting.com
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