Mirvetuximab Plus Bevacizumab Demonstrated Meaningful Efficacy
in Recurrent FRα-Positive Ovarian Cancer Across a Broad Range of
FRα Expression Regardless of Prior Treatment; Data to be
Highlighted in Oral Presentation
Additional Clinical Benefit Outcomes from Pivotal SORAYA Study
Also Reported
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced several data presentations for mirvetuximab
soravtansine (mirvetuximab) at the 2022 International Gynecologic
Cancer Society (IGCS) Annual Global Meeting in New York City. The
presentations include: consolidated efficacy and safety data from a
Phase 1b/2 study evaluating mirvetuximab in combination with
Avastin® (bevacizumab) in folate receptor alpha (FRα)-positive
recurrent ovarian cancer; the final analysis of a Phase 1b/2 study
evaluating mirvetuximab in combination with carboplatin in patients
with recurrent FRα-positive platinum-sensitive ovarian cancer; and
the clinical benefit of mirvetuximab as a monotherapy in the SORAYA
study. Two trial in progress posters from the mirvetuximab program
will also be presented.
"We are pleased with the impressive anti-tumor activity and
tolerability that these mirvetuximab doublets have generated in
recurrent ovarian cancer," said Anna Berkenblit, MD, Senior Vice
President and Chief Medical Officer of ImmunoGen. "As we await the
potential FDA approval of mirvetuximab this year, we are focused on
establishing mirvetuximab as both the combination agent of choice
and the new standard of care as a monotherapy in folate receptor
alpha positive ovarian cancer."
MIRVETUXIMAB SORAVTANSINE AND BEVACIZUMAB IN FOLATE RECEPTOR
ΑLPHA-POSITIVE OVARIAN CANCER: EFFICACY IN PATIENTS WITH AND
WITHOUT PRIOR BEVACIZUMAB Lead Author: David O'Malley, MD
Date/Time: October 1, 2022, 3:55 – 5:25 PM ET Abstract: #496
The safety and efficacy of mirvetuximab in combination with
bevacizumab were evaluated in 126 patients with recurrent
FRα-positive ovarian cancer. The primary endpoint for the study is
confirmed objective response rate (ORR) as assessed by RECIST v1.1
and secondary endpoints include duration of response (DOR) and
progression-free survival (PFS).
Key findings:
- In the overall population, mirvetuximab plus bevacizumab
demonstrated an ORR of 44% (95% CI, 35.6-53.6), a median DOR of
11.8 months (95% CI, 8.3-13.7), and median PFS of 8.2 months (95%
CI, 6.8-9.9).
- Clinical activity was observed across all levels of FRα
expression, with an ORR of 52% (95% CI, 38.6–64.5), 39% (95% CI,
25.8–53.9), and 31% (95% CI, 9.1–61.4) in high, medium, and low
expression, respectively.
- In the bevacizumab-naïve population, anti-tumor activity was
seen with an ORR of 58% (95% CI, 44.9-70.9), a median DOR of 11.8
months (95% CI, 8.3-12.9), and median PFS of 9.7 months (95% CI,
8.2-13.2).
- The safety profile of mirvetuximab plus bevacizumab reflects
the profile of each agent as a monotherapy; the most common
treatment-related adverse events (TRAEs) were low-grade, including
diarrhea (59% all grade; 2% grade 3), blurred vision (56% all
grade; 1% grade 3), and fatigue (51% all grade; 4% grade 3).
"Current treatments for patients with recurrent ovarian cancer
are, unfortunately, characterized by limited efficacy and
challenging side effects," said David O'Malley, MD, Professor,
Director of Gynecologic Oncology at the Ohio State University and
the James Cancer Center. "With activity across a broad range of FRα
expression regardless of prior treatment, these data support
mirvetuximab plus bevacizumab as an effective combination choice
for those patients who are eligible for treatment. I look forward
to further evaluating this promising and novel combination in the
platinum-sensitive maintenance setting in the randomized Phase 3
GLORIOSA study."
MIRVETUXIMAB SORAVTANSINE AND CARBOPLATIN FOR TREATMENT OF
PATIENTS WITH RECURRENT FOLATE RECEPTOR ALPHA–POSITIVE
PLATINUM-SENSITIVE OVARIAN CANCER: A FINAL ANALYSIS Lead
Author: Kathleen N. Moore, MD Date/Time: October 1, 2022, 2:05 -
2:35 PM ET Abstract: #499
A final analysis of the Phase 1b/2 FORWARD II study evaluating
the safety, tolerability, and preliminary activity of mirvetuximab
and carboplatin in patients with FRα-positive recurrent
platinum-sensitive ovarian cancer was conducted.
Key findings:
- In the overall efficacy evaluable patient group, the ORR was
71% (12 of 17); 18% (n=3) of patients had a CR and 53% (n=9) had a
partial response.
- Patients receiving mirvetuximab 6 mg/kg AIBW and carboplatin
AUC5 had an ORR of 89%, median DOR of 12.1, and median PFS of 16.5
months.
- Patients with medium/high FRα-expressing tumors had an ORR of
80%, median DOR of 24.2, and median PFS of 15.0 months across all
escalation cohorts
- The safety profile of mirvetuximab plus carboplatin reflects
the safety profile of each agent as a monotherapy.
These findings support the evaluation of mirvetuximab plus
carboplatin in Trial 420, a single-arm, Phase 2 study of
mirvetuximab plus carboplatin in platinum-sensitive ovarian cancer
patients with low, medium, or high expression of folate receptor
alpha.
CLINICAL BENEFIT OF MIRVETUXIMAB SORAVTANSINE IN OVARIAN
CANCER PATIENTS WITH HIGH FOLATE RECEPTOR ALPHA EXPRESSION: RESULTS
FROM THE SORAYA STUDY Lead Author: Robert L. Coleman, MD
Date/Time: September 30, 2022, 8:05 – 9:05 AM ET Abstract: #376
SORAYA is a single-arm study of mirvetuximab in patients with
platinum-resistant ovarian cancer whose tumors express high levels
of FRα and who have been treated with one to three prior regimens –
at least one of which included bevacizumab. Previously undisclosed
waterfall plots will be presented.
Key findings:
- Mirvetuximab monotherapy resulted in clinically meaningful
anti-tumor activity in patients with FRα-high platinum-resistant
ovarian cancer: 71% of patients experienced tumor reduction, 51%
had disease control (complete response, partial response, or stable
disease for ≥12 weeks), and preliminary overall survival, with 46%
of events reported, was 13.8 months.
- Safety and tolerability of mirvetuximab are consistent with
that observed in previous studies; adverse events were primarily
low-grade gastrointestinal and ocular events that generally
resolved with supportive care or, if needed, dose modifications and
the discontinuation rate due to TRAEs was 9%.
- Mirvetuximab demonstrated a favorable benefit-risk profile in
patients with FRα-high platinum-resistant ovarian cancer and has
the potential to be a practice-changing, biomarker-driven
therapy.
ADDITIONAL PRESENTATIONS Trial in progress posters from
ImmunoGen's PICCOLO (Abstract #1556) trial of mirvetuximab in
recurrent platinum-sensitive ovarian cancer and a Phase 2 (Abstract
#1566) investigator-sponsored combination trial of mirvetuximab
with Keytruda® (pembrolizumab) in patients with microsatellite
stable recurrent or persistent endometrial cancer will also be
presented.
Additional information can be found at igcs.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® and Keytruda® are registered trademarks of their
respective owners.
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 folate receptor
alpha positive ovarian cancer and as a combination agent of choice
for patients with ovarian cancer; the timing and presentation of
clinical data for mirvetuximab, including, but not limited to, the
evaluation of mirvetuximab in combination with bevacizumab and the
combination's evaluation in the Company's Phase 3 GLORIOSA trial,
the evaluation of mirvetuximab in combination with carboplatin,
data from the Company's PICCOLO trial, and data from a combination
trial of mirvetuximab and Keytruda; 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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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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