Data from Confirmatory Trial to be Highlighted in Oral
Presentation on Sunday, June 4
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced that results from the Phase 3 confirmatory MIRASOL
trial (GOG 3045/ENGOT OV-55) evaluating the safety and efficacy of
ELAHERE® (mirvetuximab soravtansine-gynx) compared to chemotherapy
in patients with folate receptor alpha (FRα)-positive
platinum-resistant ovarian cancer, have been selected for a
late-breaking oral presentation at the 2023 American Society of
Clinical Oncology (ASCO) Annual Meeting taking place June 2-6, 2023
in Chicago, Illinois.
"We are honored that MIRASOL has been selected as a late-breaker
presentation at ASCO, and pleased that we will be able to share the
results from the trial so quickly after they became available,"
said Anna Berkenblit, MD, Senior Vice President and Chief Medical
Officer of ImmunoGen. "Having demonstrated a statistically
significant and clinically meaningful improvement in overall
survival compared to investigator's choice of single-agent
chemotherapy, I believe ELAHERE has the potential to be practice
changing in FRα-positive, platinum-resistant ovarian cancer."
ORAL PRESENTATION
Title: Phase III MIRASOL (GOG 3045/ENGOT-ov55) Study: Initial
Report of Mirvetuximab Soravtansine vs. Investigator's Choice of
Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial
Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High
Folate Receptor-Alpha Expression Presenter: Dr. Kathleen Moore,
Associate Director of Clinical Research and Director of the
Oklahoma TSET/Sarah Cannon Phase I Program, Professor of the
Section of Gynecologic Oncology at The University of Oklahoma and
MIRASOL Principal Investigator Session: Late-Breaking Abstract
Session: Presentation and Discussion of LBA5507 Date: Sunday, June
4, 2023 Time: 7:30 am to 8:05 am CT / 8:30 am to 9:05 am ET
Late-breaking abstracts will be released at 7:00 am CT / 8:00 am
ET on the day of the scientific presentation.
POSTER PRESENTATIONS ImmunoGen will present two
additional trial-in-progress posters at ASCO.
Title: GLORIOSA: A Randomized, Open-Label, Phase 3 Study of
Mirvetuximab Soravtansine with Bevacizumab vs. Bevacizumab as
Maintenance in Platinum-Sensitive Ovarian, Fallopian Tube, or
Primary Peritoneal Cancer Presenter: Dr. David O'Malley, Professor,
Director of Gynecologic Oncology at the Ohio State University and
the James Cancer Center Abstract: TPS5622 Poster Board: 312a
Title: A Phase 1b/2 Study of Pivekimab Sunirine in Combination
with Venetoclax/Azacitidine or Magrolimab for Patients with
CD123-Positive Acute Myeloid Leukemia Presenter: Dr. Naval Daver,
Associate Professor in the Department of Leukemia at The University
of Texas MD Anderson Cancer Center Abstract: TPS7073 Poster Board:
203a
Poster abstracts will be released on Thursday, May 25, 2023 at
4:00 pm CT / 5:00 pm ET. Additional information can be found at
www.asco.org.
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.
ELAHERE® is a registered trademark of ImmunoGen, Inc.
ABOUT ELAHERE
ELAHERE (mirvetuximab soravtansine-gynx) 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.
ELAHERE is indicated for the treatment of adult patients with
folate receptor-alpha (FRα) positive, platinum-resistant epithelial
ovarian, fallopian tube, or primary peritoneal cancer, who have
received one to three prior systemic treatment regimens. Select
patients for therapy based on an FDA-approved test.
This indication is approved under accelerated approval based on
tumor response rate and durability of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in a confirmatory trial.
Eye problems are common with ELAHERE and can be severe. ELAHERE
also can cause severe or life-threatening inflammation of the lungs
that may lead to death and patients may develop nerve problems
called peripheral neuropathy during treatment. Please see full
Prescribing Information, including Boxed Warning, and Medication
Guide for ELAHERE.
FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. These
statements include, but are not limited to, the potential of
ELAHERE to change how FRα-positive, platinum-resistant ovarian
cancer is treated. 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; top-line
data may change as more patient data become available and are
subject to audit and verification procedures; the timing and
outcome of the Company's preclinical and clinical development
processes; the results of the ongoing MIRASOL trial may not support
full approval of ELAHERE and, if so, additional studies may be
required; 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 timing and outcome of the Company's anticipated
interactions with regulatory authorities; the risk that the Company
may not be able to obtain adequate price and reimbursement for any
approved products, including the potential for delays or additional
difficulties for ELAHERE in light of the FDA granting accelerated
approval; 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 March 1, 2023, the Company's
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commision on April 28, 2023, 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. ImmunoGen undertakes 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/20230509005483/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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