Trial Met Primary Endpoint with Confirmed Objective Response
Rate of 32.4%
Median Duration of Response at Data Cutoff is 5.9 Months
Continued Demonstration of Favorable Tolerability Profile
BLA Submission on Track for First Quarter of 2022
Conference Call to be Held at 8:00 a.m. ET Today
ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced positive top-line data from the pivotal SORAYA
trial evaluating the safety and efficacy of mirvetuximab
soravtansine (mirvetuximab) monotherapy in patients with folate
receptor alpha (FRα)-high platinum-resistant ovarian cancer who
have been previously treated with Avastin® (bevacizumab).
"Despite advances in the platinum-sensitive setting, most
patients with ovarian cancer eventually develop platinum-resistant
disease, for which there are limited treatment options, especially
for those patients who have previously received bevacizumab," said
Robert Coleman, MD, Chief Scientific Officer of US Oncology
Research and SORAYA Co-Principal Investigator. "Data from SORAYA
have the potential to redefine the standard of care for patients
with FRα-high platinum-resistant ovarian cancer, as this trial has
demonstrated that mirvetuximab delivers clinically meaningful
benefit in this setting, with significant and durable responses and
a favorable tolerability profile."
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 up to three prior regimens –
at least one of which included bevacizumab. The primary endpoint
for the study is confirmed objective response rate (ORR) as
assessed by investigator, including complete and partial responses,
and the key secondary endpoint is duration of response (DOR). ORR
was also assessed by blinded independent central review (BICR). The
study is designed to rule out a 12% ORR, based on expected outcomes
with available single agent chemotherapy from the AURELIA study in
patients with platinum-resistant ovarian cancer and one to two
prior lines of therapy.
Key Findings from SORAYA
SORAYA enrolled 106 patients with a median of three prior lines
of therapy (range one to four); 51% had three prior lines of
therapy and 48% had one to two prior lines of therapy. All patients
received prior bevacizumab; 48% of patients received a prior PARP
inhibitor. As of the data cutoff on November 16, 2021, the median
follow-up time was 8.1 months.
- ORR by investigator was 32.4% (95% confidence interval [CI]:
23.6%, 42.2%), including five complete responses (CRs). ORR by BICR
was 31.6% (95% CI: 22.4%, 41.9%), including five CRs. Responses
were observed regardless of prior PARP inhibitor or number of prior
lines of therapy.
- The median DOR is currently 5.9 months (95% CI: 5.6, 7.7). With
nearly half of responders continuing on therapy, the duration of
response continues to evolve and, with longer follow-up, median DOR
could range from 5.7 to just above 7 months.
- Mirvetuximab was well-tolerated, consistent with the known
safety profile seen in more than 700 patients treated in the
broader mirvetuximab program. Treatment-related adverse events led
to dose reductions in 19% of patients, dose delays in 32% of
patients, and discontinuations in 7% of patients. The most common
treatment-related adverse events included blurred vision (41% all
grade; 6% grade 3+), keratopathy (35% all grade; 9% grade 3+), and
nausea (29% all grade; 0% grade 3+).
"These data have the potential to be transformative for ovarian
cancer patients and their physicians," 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. "In the
platinum-resistant setting and particularly in later-line treated
patients, response rates with available therapy are in the single
digits with significant toxicities. With an ORR above 30%, a
duration of response of around six months, and a treatment-related
discontinuation rate below 10%, mirvetuximab shows impressive
activity and tolerability for patients with platinum-resistant
ovarian cancer. If approved, mirvetuximab will become a critical
therapeutic option for patients with FRα-high ovarian cancer."
"We are extremely pleased with the top-line data from SORAYA,
which support our strategy to position mirvetuximab as the standard
of care for patients with FRα-high ovarian cancer," said Anna
Berkenblit, MD, Senior Vice President and Chief Medical Officer of
ImmunoGen. "Mirvetuximab's efficacy far exceeds that which is
expected with available therapies. This is particularly encouraging
given the majority of patients in SORAYA were fourth-line, and the
safety profile and anti-tumor activity replicate those previously
generated in the program. We are deeply grateful to all of the
patients and physicians who participated in this study, and we look
forward to presenting the full SORAYA data at a medical meeting
next year."
"This is an exciting moment, both for the field of ovarian
cancer and for ImmunoGen, and the outcomes from SORAYA further
validate our longstanding history of innovation in ADCs," said Mark
Enyedy, ImmunoGen's President and Chief Executive Officer. "We are
moving forward expeditiously to complete the BLA for mirvetuximab,
with the goal of submitting the application to FDA for accelerated
approval in the first quarter of 2022. In parallel, commercial
preparations are well underway to support the potential launch of
mirvetuximab next year. To this end, we recently hired our Chief
Commercial Officer and are focused on having the right talent,
resources, and infrastructure in place to maximize the potential
impact of mirvetuximab for women living with ovarian cancer. Beyond
SORAYA, we expect to generate top-line data from our confirmatory
MIRASOL trial in the third quarter of 2022 to support the potential
full approval of mirvetuximab. We are also working to expand
mirvetuximab monotherapy into later-line platinum-sensitive disease
and, as part of our efforts to establish mirvetuximab as the
combination agent of choice, evaluating mirvetuximab doublets in
earlier lines of treatment, all with the goal of furthering our
mission to offer more patients more good days."
CONFERENCE CALL INFORMATION
ImmunoGen will hold a conference call today at 8:00 a.m. ET to
discuss these results. To access the live call by phone, dial (877)
621-5803; the conference ID is 7577328. The call may also be
accessed through the Investors and Media section of the Company's
website, www.immunogen.com. Following the call, a replay will be
available at the same location.
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 based on
management's current expectations. 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 the Company's product candidates,
including the submission of the Company's BLA to the FDA for
mirvetuximab; the potential of mirvetuximab to become a standard of
care and transform the Company into a fully integrated oncology
company; the potential of mirvetuximab to become a combination
agent of choice; the presentation of preclinical and clinical data
on the Company's product candidates, including MIRASOL data in the
third quarter of 2022; and the Company's business and product
development strategies. For these statements, ImmunoGen claims the
protection of the safe harbor for forward-looking statements
provided by the Private Securities Litigation Reform Act of 1995.
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: 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 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; 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, 2021, and other
reports filed with the Securities and Exchange Commission.
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version on businesswire.com: https://www.businesswire.com/news/home/20211130005310/en/
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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