Two Data Sets to be Presented at 2022 Annual Meeting
Poster Highlighting Updated Data from SORAYA Characterizing
Anti-Tumor Activity Selected for Best of ASCO® Program: Tumor
Reduction in 71.4% of Patients and Preliminary Median Overall
Survival of 13.8 Months in High Folate Receptor Alpha Patients with
Platinum-Resistant Ovarian Cancer
Pooled Data from Mirvetuximab Program in 464 Patients
Demonstrate Differentiated and Consistent Safety Profile
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced additional efficacy data from the pivotal SORAYA
study evaluating mirvetuximab soravtansine (mirvetuximab)
monotherapy in patients with folate receptor alpha (FRα)-high
platinum-resistant ovarian cancer who have been previously treated
with Avastin® (bevacizumab) and an integrated safety summary of
single-agent mirvetuximab across multiple studies in patients with
FRα-positive recurrent ovarian cancer. These findings will be
highlighted in two posters at the 2022 American Society of Clinical
Oncology (ASCO) Annual Meeting, which is being held June 3-7, 2022.
The data from SORAYA have been selected for the Best of ASCO®
Program.
"Treatment options remain limited for patients with
platinum-resistant ovarian cancer, particularly for those who have
received prior bevacizumab, and are associated with low response
rates, short durations of response, and considerable toxicities,"
said Anna Berkenblit, MD, Senior Vice President and Chief Medical
Officer of ImmunoGen. "We believe these data further reinforce
mirvetuximab's potential to become a new standard of care in this
population. With our biologics license application accepted and
filed by FDA with Priority Review, we look forward to bringing
mirvetuximab to patients with the most urgent need later this
year."
CHARACTERIZATION OF ANTI-TUMOR ACTIVITY IN THE SORAYA
STUDY SORAYA enrolled 106 platinum-resistant ovarian cancer
patients with high FRα expression who have been previously treated
with 1 to 3 prior systemic treatments, at least one of which
included bevacizumab. The primary endpoint was confirmed objective
response rate (ORR) as assessed by investigator. Secondary
endpoints included duration of response (DOR) as assessed by
investigator, CA-125 response, safety and tolerability,
progression-free survival (PFS), overall survival (OS); ORR, DOR,
and PFS by blinded independent central review were sensitivity
analyses. Data from SORAYA were first presented at the Society of
Gynecologic Oncology (SGO) 2022 Annual Meeting; the updated
analyses to be presented at ASCO are based on the 120-day cut-off
date of April 29, 2022.
- ORR by investigator was 32.4% (95% confidence interval [CI]:
23.6%, 42.2%), including 5 complete responses. Median time to
response was 1.5 months (range 1.0 to 5.6) and 71.4% of patients
demonstrated tumor reduction.
- The disease control rate (DCR), defined as complete response
(CR), partial response, or stable disease maintained for ≥12 weeks,
was 51.4%.
- The median DOR was 6.9 months (95% CI: 5.6, 9.7) by
investigator, with 5 responders continuing on mirvetuximab as of
April 29, 2022.
- The median PFS assessed by investigator was 4.3 months (95% CI:
3.7, 5.2).
- The preliminary median OS was 13.8 months, with 54% of the
evaluable patient population event-free.
- In the sensitivity analyses by blinded independent central
review, outcomes were similar: ORR 30.2% (95% CI: 21.3%, 40.4%)
with 6 CRs; mDOR not reached (95% CI: 5.0, NR); mPFS 5.5 months
(95% CI: 3.8, 6.9).
- In responders, depth and duration of response did not appear to
be affected by dose reductions.
- Mirvetuximab was well-tolerated, consistent with previous
studies. The most common treatment-related adverse events (TRAE)
included blurred vision (41% all grade, 6% grade 3+), keratopathy
(29% all grade, 9% grade 3+), and nausea (29% all grade, 0% grade
3+).
- TRAEs generally resolved with supportive care or, if needed,
dose modifications; the discontinuation rate due to TRAEs was
9%.
- Kaplan-Meier plots for PFS and OS to be included in
poster.
"I believe these additional analyses from SORAYA further support
mirvetuximab's potential to become the first biomarker-directed
agent indicated for patients with platinum-resistant ovarian
cancer," said Ursula Matulonis, MD, Chief of the Division of
Gynecologic Oncology at the Dana-Farber Cancer Institute, Professor
of Medicine at the Harvard Medical School, and SORAYA Co-Principal
Investigator. "The tumor reduction observed in over 70% of
patients, along with the PFS curve and the preliminary median
overall survival of 13.8 months, are impressive. If approved, I
look forward to being able to offer mirvetuximab to my patients and
continuing to support its further development in patients with
ovarian cancer."
INTEGRATED SAFETY SUMMARY OF SINGLE-AGENT MIRVETUXIMAB
SORAVTANSINE This retrospective pooled analysis included 464
patients with FRα-positive, recurrent ovarian cancer across three
studies: a Phase 1 first-in-human trial, the Phase 3 FORWARD I
trial, and the pivotal Phase 3 SORAYA trial.
- Mirvetuximab monotherapy has a differentiated safety profile
consisting primarily of low-grade gastrointestinal and ocular
events; adverse events generally resolved and were managed with
supportive care and, if needed, dose modifications. The
discontinuation rate due to TRAEs was 7%.
- The most common TRAEs included blurred vision (42% all grade,
3% grade 3+), nausea (40% all grade, 2% grade 3+), diarrhea (33%
all grade, 2% grade 3+), fatigue (31% all grade, 2% grade 3+),
keratopathy (26% all grade, 3% grade 3+), and dry eye (22% all
grade, 1% grade 3+).
- Mirvetuximab monotherapy did not result in any corneal ulcers
or perforations, and no patients had permanent ocular
sequelae.
- The majority of patients with ocular events did not require
dose delay or dose reduction; <1% of patients discontinued
mirvetuximab due to an ocular event.
"Having personally treated over 100 patients with mirvetuximab,
I have helped my colleagues better understand how to manage the
associated ocular events," 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 MIRASOL Principal Investigator. "With prevention and
mitigation strategies in place, patients presenting with ocular
events have been able to complete their treatment, maintain their
responses, and had no permanent sequelae from these events. These
data demonstrate mirvetuximab's differentiated safety profile and I
look forward to the potential approval and launch later this
year."
POSTER SESSION DETAILS The following posters will be
available on Saturday, June 4 in the ASCO Meeting Library:
Title: Integrated Safety Summary of Single-Agent
Mirvetuximab Soravtansine in Patients with Folate Receptor α (FRα)
Positive Recurrent Ovarian Cancer: Phase I and III Clinical Trials
Lead Author: Kathleen N. Moore, MD Date/Time: June 4,
2022, 2:15 PM – 5:15 PM EDT Abstract: 5574 Poster:
450
Title: Mirvetuximab Soravtansine (MIRV) in Patients with
Platinum-Resistant Ovarian Cancer with High Folate Receptor Alpha
(FRα) Expression: Characterization of Anti-Tumor Activity in the
SORAYA Study Lead Author: Ursula A. Matulonis, MD
Date/Time: June 4, 2022, 5:30 PM – 7:00 PM EDT
Abstract: 5512 Poster: 391
Additional information can be found at www.asco.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.
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, the commercial launch of mirvetuximab and
the potential of mirvetuximab to serve as a new standard of care
for patients with platinum-resistant ovarian cancer; and the timing
and presentation of preclinical and clinical data on the Company's
product candidates. 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, 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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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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