ImmunoGen Provides Regulatory Update on Mirvetuximab Soravtansine Monotherapy in Ovarian Cancer
May 15 2019 - 6:30AM
Business Wire
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 the United States Food and Drug Administration
(FDA) has recommended that the Company conduct a new Phase 3
randomized trial to evaluate the safety and efficacy of
mirvetuximab soravtansine in patients with high folate receptor
alpha (FRα)-positive, platinum-resistant ovarian cancer as part of
a Type C meeting held this week.
ImmunoGen requested the meeting to discuss the results of the
Phase 3 FORWARD I trial and a potential path to registration for
mirvetuximab monotherapy. The agency advised that, because FORWARD
I did not meet its primary endpoint under the pre-specified
statistical analysis plan, the data generated assessing the
secondary endpoints from the study could not be used to support an
application for accelerated approval. FDA acknowledged that
platinum-resistant ovarian cancer is a disease with unmet need,
provided guidance regarding the design and endpoints of a potential
registration study, and encouraged the Company to return to discuss
a proposed study design.
“We are encouraged by the consistent signal of anti-tumor
activity and the favorable benefit-risk profile in patients with
high FRα expression in our Phase 3 FORWARD I trial,” said Anna
Berkenblit, MD, Senior Vice President and Chief Medical Officer of
ImmunoGen. “We appreciate the constructive engagement with FDA and
look forward to aligning with the agency on the design of a new
registration trial in this population.”
“Our meeting with FDA enabled us to clarify a regulatory path
forward for mirvetuximab and we are evaluating all avenues to bring
this promising therapy to ovarian cancer patients,” said Mark
Enyedy, ImmunoGen’s President and Chief Executive Officer. “The
mirvetuximab combination cohorts continue to advance and, with
approximately $270 million on the balance sheet as of the end
of Q1, we remain focused on developing innovative ADC therapeutics
and delivering more good days to people with cancer.”
As previously announced, ImmunoGen is conducting an operational
review of the business with the objective of extending the
Company’s cash runway.
CONFERENCE CALL INFORMATIONImmunoGen will host a
conference call on May 15, 2019 at 8 a.m. ET to discuss the recent
regulatory meeting with FDA. To access the live call by phone, dial
334-323-0505; the conference ID is 5203727. The call may also be
accessed through the "Investors and Media" section of the Company's
website, www.immunogen.com. Following the live webcast, a replay of
the call will be available at the same location through May 29,
2019.
ABOUT FORWARD IFORWARD I is a Phase 3 trial in which 366
patients were randomized 2:1 to receive either mirvetuximab
soravtansine or the physician's choice of single-agent chemotherapy
(pegylated liposomal doxorubicin, topotecan, or weekly paclitaxel).
Eligible patients were diagnosed with platinum-resistant ovarian
cancer that expresses medium or high levels of FRα and were treated
with up to three prior regimens. The primary endpoint of this study
was progression free survival (PFS), which was assessed in the
entire study population and in the subset of patients with high FRα
expression. ImmunoGen estimates that 12,000-14,000 patients per
year in the U.S. meet these criteria, with a comparable number in
the major markets in Europe.
ImmunoGen partnered with the GOG Foundation Inc., a leader in
clinical research in gynecologic malignancies, on FORWARD I, which
was conducted in North America and Europe.
ABOUT MIRVETUXIMAB SORAVTANSINEMirvetuximab 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 IMMUNOGENImmunoGen 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.” The
Company has built a productive platform generating a broad pipeline
of ADCs targeting solid tumors and hematologic malignancies.
Learn more about who we are, what we do, and how we do it at
www.immunogen.com.
FORWARD-LOOKING STATEMENTSThis 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 and its collaboration partners' product
programs; and the presentation of preclinical and clinical data on
the Company’s and collaboration partners’ 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 timing and
outcome of ImmunoGen's and the Company's collaboration partners'
research 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; ImmunoGen's
ability to financially support its product programs; ImmunoGen's
dependence on collaborative partners; industry merger and
acquisition activity; and other factors more fully described 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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version on businesswire.com: https://www.businesswire.com/news/home/20190515005239/en/
INVESTOR RELATIONS CONTACTSarah
Kiely781-895-0600sarah.kiely@immunogen.com
MEDIA CONTACTCourtney
O’Konek781-895-0600courtney.okonek@immunogen.com
OR
FTI ConsultingRobert
Stanislaro212-850-5657robert.stanislaro@fticonsulting.com
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