ImmunoGen Presents Retrospective Analysis of Extended Treatment Benefit from Multiple Trials of Mirvetuximab Soravtansine in Ovarian Cancer at ESGO
October 28 2022 - 8:40AM
Business Wire
Patients with Extended Treatment Benefit Showed an Objective
Response Rate of 77.5% and a Median Duration of Response of 22.1
Months
Overall Adverse Event Profile Observed Consistent with Known
Safety Profile of Mirvetuximab with Minimal Cumulative
Toxicities
Study Outcomes in Patients with Long-Term Use Further Support
Mirvetuximab’s Potential to Become New Standard of Care for
FRα-positive Ovarian Cancer
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced findings from a retrospective pooled analysis of
patients who achieved extended treatment benefit (ETB) with
mirvetuximab soravtansine (mirvetuximab) monotherapy across three
clinical trials in folate receptor alpha (FRα)–positive recurrent
ovarian cancer. These findings were highlighted in a poster
presentation at the 23rd Congress of the European Society of
Gynaecological Oncology (ESGO) in Berlin, Germany. A trial in
progress poster from the mirvetuximab program will also be
presented.
"We believe the study outcomes presented at ESGO support the
potential benefit mirvetuximab can have for a subset of patients on
a long-term basis and add to the strong, existing foundation of
data that supports mirvetuximab’s potential to become the new
standard of care for FRα-positive ovarian cancer," said Anna
Berkenblit, MD, Senior Vice President and Chief Medical Officer of
ImmunoGen. “With the PDUFA date for mirvetuximab rapidly
approaching, we look forward to the opportunity to bring this novel
therapy to patients before the end of this year.”
CHARACTERIZATION OF EXTENDED TREATMENT BENEFIT FROM THREE
PHASE 1 AND 3 CLINICAL TRIALS EXAMINING PATIENTS WITH FOLATE
RECEPTOR ALPHA–POSITIVE RECURRENT OVARIAN CANCER TREATED WITH
SINGLE-AGENT MIRVETUXIMAB SORAVTANSINE Lead Author: Ana Oaknin,
MD Date/Time: October 28, 2022, 2:40 – 3:40 PM CET / 8:40 – 9:40 AM
ET Poster: #PA-048
A retrospective pooled analysis of patients who achieved ETB
with mirvetuximab monotherapy was conducted across three studies -
the Phase 1 IMGN853-0401 trial, the Phase 3 FORWARD I trial, and
the Phase 3 SORAYA trial. ETB was defined as progression-free
survival (PFS) for more than 12 months per investigator assessment.
FRα expression levels were evaluated by immunohistochemistry
(IHC).
Key findings:
- In a pooled analysis of 466 patients, mirvetuximab monotherapy
demonstrated ETB in 40 patients (9%).
- Most patients with ETB had stage III disease (83%), 1 prior
line of therapy (55%), and prior Avastin® (bevacizumab) exposure
(60%).
- EBT occurred in patients with a wide range of FRα expression,
but did so predominantly among those with high FRα expression.
- Patients with ETB had an objective response rate (ORR) of 77.5%
(31 out of 40 patients), with 10 (25%) achieving a complete
response and 21 (52.5%) achieving a partial response. The remaining
8 patients (20%) with ETB had a best response of stable disease and
one patient was not evaluable.
- Median duration of response (DOR) in patients with ETB was 22.1
months (95% CI, 13.8-60.0).
- Median PFS in patients with ETB was 17.0 months (95% CI,
16.4-23.1).
- In patients with ETB, the overall adverse event (AE) profile
was consistent with the previously reported integrated safety
summary (ISS) of 464 patients, with no new safety signals
identified and minimal cumulative toxicities.
- AEs were primarily low-grade gastrointestinal and ocular events
that generally resolved with supportive care or, if needed, dose
modifications.
“Treatment options for patients with platinum-resistant ovarian
cancer are extremely limited and characterized by low activity and
considerable toxicity," said Ana Oaknin, Head of Gynecologic Tumors
Unit,Vall d'Hebron Institute of Oncology, Senior Medical Oncologist
and Attending Physician, Medical Oncology Department, Vall d'Hebron
University Hospital. "The results from this analysis, coupled with
a favorable tolerability and a consistent safety profile, add to
the excitement I and many other physicians now have for the
potential of mirvetuximab for women with FRα-positive
platinum-resistant ovarian cancer.”
ADDITIONAL PRESENTATIONS
A trial in progress poster for a randomized Phase 2
investigator-sponsored trial (IST) of mirvetuximab in combination
with carboplatin in patients with FRα-high recurrent ovarian cancer
will also be presented.
Additional information can be found at
www.congress.esgo.org.
ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine is a first-in-class ADC comprising a
folate receptor alpha-binding antibody, cleavable linker, and the
maytansinoid payload DM4, a potent tubulin inhibitor designed to
kill the targeted cancer cells.
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, a member of the
Roche Group.
FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. These
statements include, but are not limited to, ImmunoGen's
expectations related to: the occurrence, timing, and outcome of
potential preclinical, clinical, and regulatory events related to,
and the potential benefits of, the Company's product candidates,
including, but not limited to, the review of the Company's BLA to
the FDA for mirvetuximab and full approval of mirvetuximab, and the
potential of mirvetuximab to serve as a new standard of care for
patients with FRα-positive ovarian cancer; the timing and
presentation of clinical data for the mirvetuximab program; and the
Company's business and product development strategies. 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 outcome of the Company's preclinical and clinical
development processes; the difficulties inherent in the development
of novel pharmaceuticals, including uncertainties as to the timing,
expense, and results of preclinical studies, clinical trials, and
regulatory processes; the Company's ability to financially support
its product programs; the timing and outcome of the Company's
anticipated interactions with regulatory authorities; risks and
uncertainties associated with the scale and duration of the
COVID-19 pandemic and the resulting impact on ImmunoGen's industry
and business; and other factors as set forth in the Company's
Annual Report on Form 10-K filed with the Securities and Exchange
Commission on February 28, 2022, the Company's Quarterly Reports on
Form 10-Q filed with the Securities and Exchange Commission on May
6, 2022 and August 1, 2022, and other reports filed with the
Securities and Exchange Commission. The forward-looking statements
in this press release speak only as of the date of this press
release. We undertake no obligation to update any forward-looking
statement, whether as a result of new information, future
developments or otherwise, except as may be required by applicable
law.
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version on businesswire.com: https://www.businesswire.com/news/home/20221028005044/en/
INVESTOR RELATIONS ImmunoGen Anabel Chan 781-895-0600
anabel.chan@immunogen.com
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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