ImmunoGen Announces Accelerated Approval Pathway for Mirvetuximab Soravtansine in Ovarian Cancer
December 17 2019 - 6:30AM
Business Wire
Top-Line Data from New Pivotal Single-Arm Trial, SORAYA,
Expected in First Half of 2021
Confirmatory MIRASOL Trial for Mirvetuximab on Track to Start by
Year-End
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 that the U.S. Food and Drug Administration (FDA)
has advised that a new single-arm study in platinum-resistant
ovarian cancer could support accelerated approval for mirvetuximab
soravtansine. Based on this guidance, the company will initiate
SORAYA, a pivotal trial to evaluate mirvetuximab monotherapy in
women with folate receptor alpha (FRα)-high platinum-resistant
ovarian cancer who have been previously treated with Avastin®
(bevacizumab).
“We have engaged in constructive discussions with FDA and
evaluated all avenues to bring mirvetuximab to patients more
quickly,” said Mark Enyedy, ImmunoGen’s President and Chief
Executive Officer. “Having aligned with the agency that women with
FRα-high platinum-resistant ovarian cancer that has progressed
after prior treatment with bevacizumab require better therapeutic
options, we are pleased to advance mirvetuximab in this patient
population with SORAYA, which, if successful, would enable us to
submit an application for accelerated approval during the second
half of 2021. We anticipate enrolling the first patient in SORAYA
next quarter and expect top-line data from the study in
mid-2021.”
ImmunoGen’s mirvetuximab program now includes two new trials,
SORAYA and MIRASOL, which will enroll concurrently.
SORAYA: Pivotal Trial SORAYA is a single-arm
trial with mirvetuximab that will enroll approximately 100
patients. Eligibility criteria include patients with
platinum-resistant ovarian cancer whose tumors express high levels
of FRα using the PS2+ scoring method, and who have been treated
with up to three prior regimens – at least one of which included
bevacizumab. The primary endpoint of this study is overall response
rate by investigator assessment and the key secondary endpoint is
duration of response.
MIRASOL: Confirmatory Trial MIRASOL is a
randomized Phase 3 trial in which 430 patients will be randomized
1:1 to receive either mirvetuximab or investigator’s choice of
single-agent chemotherapy (weekly paclitaxel, pegylated liposomal
doxorubicin, or topotecan). Eligibility criteria include patients
with platinum-resistant ovarian cancer whose tumors express high
levels of FRα using the PS2+ scoring method, and who have been
treated with up to three prior regimens. The primary endpoint of
this study is progression free survival by investigator assessment.
The key secondary endpoints include: overall response rate, overall
survival, and patient-reported outcomes.
“We have reviewed the data generated from our Phase 1 and
FORWARD I studies using the PS2+ scoring method and have identified
70 patients who would meet the key eligibility criteria for SORAYA.
The overall response rate in these patients was 31.4% with 95% CI
(20.9%, 43.6%) and a median duration of response of 7.8 months with
95% CI (3.98, -),” said Anna Berkenblit, MD, Senior Vice President
and Chief Medical Officer of ImmunoGen. “These data compare quite
favorably to the response rate seen with single agent chemotherapy
in platinum resistant disease, which was 12% in the AURELIA and
CORAIL trials, and included patients naïve to and previously
treated with bevacizumab.”
Berkenblit continued, “Replicating these data in SORAYA would
support an application for accelerated approval in advance of the
completion of MIRASOL, which would thereafter provide the
randomized data needed for conversion to full approval. We are
delighted to advance both studies as soon as possible.”
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 7190603. The call may also be accessed through the Investors
and Media section of immunogen.com. Following the call, a replay
will be available at the same location.
ABOUT MIRVETUXIMAB SORAVTANSINE Mirvetuximab soravtansine
(IMGN853) is the first folate receptor alpha (FRα)-targeting ADC.
It uses a humanized FRα-binding antibody to target the ADC
specifically to FRα-expressing cancer cells and a potent anti-tumor
agent, DM4, to kill the targeted cancer cells.
ABOUT IMMUNOGEN ImmunoGen is developing the next
generation of antibody-drug conjugates 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, Inc.
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 pre-clinical,
clinical, and regulatory events related to the Company’s product
candidates. 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:
the Company’s ability to control future spending to enable it to
fund its remaining operations through the release of top-line
results from the SORAYA and MIRASOL trials, as well as the risks
and uncertainties inherent in the Company’s development programs,
including clinical studies and regulatory processes, their timings
and results. A review of these risks can be found in ImmunoGen’s
Annual Report on Form 10-K for the year ended December 31, 2018 and
other reports filed with the Securities and Exchange
Commission.
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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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