Patient-Reported Outcomes with Mirvetuximab Versus Chemotherapy
in FORWARD I Study Reinforces Differentiated Tolerability
Profile
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced findings from an analysis of patient-reported
outcomes (PROs) with mirvetuximab soravtansine (mirvetuximab)
versus chemotherapy in the randomized Phase 3 FORWARD I study in
platinum-resistant ovarian cancer. The Company also announced
population pharmacokinetic (PK) and exposure response (ER) analyses
across multiple clinical trials evaluating mirvetuximab monotherapy
in folate receptor alpha (FRα)-positive ovarian cancer. These
findings will be highlighted in three posters at the European
Society for Medical Oncology (ESMO) Congress in Paris, France.
"The data presented at ESMO continue to support mirvetuximab's
potential to displace single-agent chemotherapy in FRα-positive
ovarian cancer and will serve as a guide as we seek to advance the
broader development program," said Anna Berkenblit, MD, Senior Vice
President and Chief Medical Officer of ImmunoGen. "With our
biologics license application for mirvetuximab under Priority
Review with FDA, we look forward to potentially bringing this novel
therapy to patients later this year."
ANALYSES OF PATIENT-REPORTED OUTCOMES WITH MIRVETUXIMAB
SORAVTANSINE VERSUS STANDARD CHEMOTHERAPY IN THE RANDOMIZED PHASE 3
FORWARD I STUDY IN OVARIAN CANCER (GOG 3011) Lead Author:
Kathleen N. Moore, MD Date/Time: September 11, 2022, 12:00 – 1:00
PM CEST / 6:00 – 7:00 AM ET Poster: #532P
The Phase 3 FORWARD I trial enrolled 366 patients who were
randomized 2:1 to receive either mirvetuximab or the physician's
choice of single-agent chemotherapy (pegylated liposomal
doxorubicin, topotecan, or weekly paclitaxel). Eligible patients
were diagnosed with platinum-resistant ovarian cancer that
expresses medium or high levels of FRα and were treated with up to
three prior regimens. The primary endpoint was progression-free
survival (PFS), which was assessed in the entire study population
and in the subset of patients with high FRα expression. Patients
completed PRO assessments during screening, on day 1 of cycle 1,
every 9 weeks thereafter (±1 week) until disease progression, and
at the end of treatment visit.
Key findings:
- In the intent-to-treat (ITT) population, a statistically
significant improvement in the number of patients achieving a
15-point improvement in gastrointestinal (GI) symptoms was observed
at week 8/9 in patients treated with mirvetuximab versus
chemotherapy (31.7% vs 14.0% P = 0.0162).
- The likelihood of GI symptom deterioration was 70% lower with
mirvetuximab in the ITT population compared with chemotherapy (95%
CI, 0.15–0.60; P=0.0007).
- In the FRα-high population, the likelihood of GI symptom
deterioration was 80% lower with mirvetuximab compared with
chemotherapy (95% CI, 0.10–0.54; P=0.0007).
- In both the ITT and FRα-high patient populations, improvements
were seen with mirvetuximab compared with chemotherapy across
multiple side effects, including sexuality, hair loss, pain
severity, body image, and general improvement in ovarian
cancer–specific symptoms.
- In both the ITT and FRα-high patient populations, there were
statistically significant benefits in physical functioning for
mirvetuximab over chemotherapy.
"An unmet need remains for safe, effective, and well-tolerated
therapeutic options for patients with platinum-resistant ovarian
cancer, despite treatment advancements seen in this setting," said
Kathleen Moore, Director of the Oklahoma TSET Phase I Program,
Professor of the Section of Gynecologic Oncology at The University
of Oklahoma College of Medicine and FORWARD I Co-Principal
Investigator. "The improved PROs associated with mirvetuximab
compared to chemotherapy reinforce the differentiated tolerability
profile of mirvetuximab and, coupled with its compelling anti-tumor
activity and favorable safety, support its potential to serve as a
new standard of care for patients with FRα-positive ovarian
cancer."
EXPOSURE RESPONSE ANALYSIS FOR EFFICACY AND SAFETY OF
MIRVETUXIMAB SORAVTANSINE IN PATIENTS WITH FOLATE RECEPTOR
ΑLPHA-POSITIVE CANCER Lead Author: Ursula A. Matulonis, MD
Date/Time: September 11, 2022, 12:00 -1:00 PM CEST / 6:00 – 7:00 AM
ET Poster: #592P
An ER analysis was conducted across three studies - the Phase 1
IMGN853-0401 trial, the Phase 3 FORWARD I trial, and the Phase 3
SORAYA trial - to understand the relationship between exposure to
single-agent mirvetuximab and the efficacy and safety responses
observed in patients with FRα-positive tumors.
Key findings:
- Both efficacy, in terms of objective response rate (ORR) and
PFS, and ocular adverse events (AEs) were higher with increased
exposure to mirvetuximab.
- These data highlight the importance of adherence to recommended
mirvetuximab dosing guidelines in clinical practice.
POPULATION PHARMACOKINETIC ANALYSIS OF MIRVETUXIMAB
SORAVTANSINE IN PATIENTS WITH FOLATE RECEPTOR ALPHA-POSITIVE
CANCER Lead Author: Kathleen N. Moore, MD Date/Time: September
11, 2022, 12:00 – 1:00 PM CEST / 6:00 – 7:00 AM ET Poster:
#605P
A PK analysis, taking into account patient demographics and
clinical characteristics, was conducted across three studies -
IMGN853-0401, FORWARD I, and SORAYA - to understand the efficacy
and safety of mirvetuximab in patients with FRα-positive
tumors.
Key findings:
- Dosing adjustments do not appear to be necessary for patients
with mild or moderate renal impairment or mild hepatic
impairment.
- The analyses support the final recommended dose of 6 mg/kg
based on adjusted ideal body weight (AIBW) every 3 weeks with
balanced efficacy and safety.
Additional information can be found at www.esmo.org.
ABOUT MIRVETUXIMAB SORAVTANSINE Mirvetuximab soravtansine
(IMGN853) is a first-in-class ADC comprising a folate receptor
alpha-binding antibody, cleavable linker, and the maytansinoid
payload DM4, a potent tubulin-targeting agent, 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.
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
platinum-resistant ovarian cancer; the timing and presentation of
clinical data for mirvetuximab; 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/20220911005025/en/
INVESTOR RELATIONS CONTACT ImmunoGen Anabel Chan
781-895-0600 anabel.chan@immunogen.com
MEDIA CONTACTS 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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