Trial Met Primary Endpoint with Confirmed Objective Response
Rate of 32.4%, including 5 Complete Responses; Updated Median
Duration of Response of 6.9 Months
Mirvetuximab Demonstrated Meaningful Anti-Tumor Activity,
Consistent Safety, and Favorable Tolerability in FRα-High
Platinum-Resistant Ovarian Cancer
BLA Submission Expected this Month
Investor Event to be Held on Sunday, March 20 at 7:30 am
MST/10:30 am EDT
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced full results from the pivotal SORAYA trial
evaluating the efficacy and safety 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). The results are
being presented by Dr. Ursula Matulonis in the late-breaking
abstract plenary session on Saturday, March 19 at the Society of
Gynecologic Oncology (SGO) 2022 Annual Meeting in Phoenix, AZ.
“Patients with platinum-resistant ovarian cancer have limited
treatment options, and these are associated with low response rates
and significant toxicity," 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. "With an objective response rate
of 32.4%, far exceeding that seen with current therapies, and a
median duration of response approaching seven months, mirvetuximab
continues to demonstrate impressive efficacy in patients with
platinum-resistant disease who have already received bevacizumab.
The anti-tumor activity and consistent safety and tolerability data
from the SORAYA trial further underscore the potential of
mirvetuximab, if approved, to become a practice-changing,
biomarker-driven standard of care for these patients.”
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. The primary endpoint
for the study is confirmed objective response rate (ORR) as
assessed by investigator 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 of 4% to 13% with available single agent
chemotherapy. Data previously generated in a post-hoc pooled
analysis of seventy patients from prior studies of mirvetuximab in
platinum-resistant disease formed the basis for the design of
SORAYA, with an investigator-assessed ORR of 31.4%, median DOR of
7.8 months, and median progression-free survival (PFS) of 4.4
months.
Key Findings from SORAYA
SORAYA enrolled 106 patients with a median of three prior lines
of therapy; 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
(PARPi).
- Confirmed 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. Response rates were consistent regardless of number of prior
lines of therapies or prior PARPi.
- 1-2 prior lines of therapy: ORR by investigator was 35.3% (95%
CI: 22.4%, 49.9%).
- 3 prior lines of therapy: ORR by investigator was 30.2% (95%
CI: 18.3%, 44.3%).
- Prior PARPi exposure: ORR by investigator was 38.0% (95% CI:
24.7%, 52.8%).
- Without prior PARPi exposure: ORR by investigator was 27.5%
(95% CI: 15.9%, 41.7%).
- The median DOR was 6.9 months (95% CI: 5.6, 8.1) by
investigator as of the March 3, 2022 data cut-off.
- The median PFS was 4.3 months (95% CI: 3.7, 5.1) by
investigator and 5.5 months (95% CI: 3.8, 6.9) by BICR.
- 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 were low-grade and generally
reversible, including blurred vision (41% all grade; 6% grade 3),
keratopathy (36% all grade; 8% grade 3+), and nausea (29% all
grade; 0% grade 3).
“We are thrilled with the SORAYA results, which are remarkably
consistent with data previously generated with mirvetuximab in a
heavily-pretreated population of platinum-resistant ovarian cancer
patients that included prior exposure to bevacizumab. Based on the
impressive anti-tumor activity, durability of response, and safety
profile observed in SORAYA, we believe mirvetuximab has the
potential to displace single-agent chemotherapy as the standard of
care for FRα-high platinum-resistant ovarian cancer,” said Anna
Berkenblit, MD, Senior Vice President and Chief Medical Officer of
ImmunoGen. “We are very grateful for all of the patients and
physicians who committed their time and effort to this study, and
with these positive results, we expect to submit the BLA for
mirvetuximab this month to support potential accelerated approval
in the US this year. The strength and consistency of the SORAYA
data give us confidence in a positive outcome in the ongoing
confirmatory MIRASOL trial, intended to support the potential full
approval of mirvetuximab, with top-line data anticipated in the
third quarter.”
Oral Presentation Details
Title: Efficacy and Safety of Mirvetuximab Soravtansine in
Patients with Platinum-Resistant Ovarian Cancer with High Folate
Receptor Alpha Expression: Results from the SORAYA Study Session:
Scientific Plenary IV: Late-Breaking Abstracts Session Date:
Saturday, March 19, 2022 Session Time: 4:15 pm to 5:45 pm MST/7:15
pm to 8:45 pm EDT
Other Presentations
Trial in progress posters from ImmunoGen's MIRASOL and PICCOLO
trials of mirvetuximab in ovarian cancer and a Phase 2
investigator-sponsored combination trial of mirvetuximab with
carboplatin as a neoadjuvant therapy for patients with newly
diagnosed ovarian cancer will also be presented. Final data from
the mirvetuximab plus bevacizumab platinum-agnostic combination,
which were originally shared at ASCO 2021, will also be featured in
a seminal presentation.
Additional information can be found at www.sgo.org.
INVESTOR EVENT INFORMATION
ImmunoGen will hold an investor event to discuss the SORAYA oral
presentation, featuring a roundtable with key opinion leaders, on
Sunday, March 20 at 7:30 am MST/10:30 am EDT in the Moly Meeting
Room at the Westin Phoenix Downtown. To access the live event by
phone, dial (877) 621-5803; the conference ID is 1986619. The event
may also be accessed via webstream on 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. 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 and full approval of
mirvetuximab; the potential of mirvetuximab to become a standard of
care; 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. 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;
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220319005002/en/
INVESTOR RELATIONS AND 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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