Trial Did Not Meet Primary Endpoint of Progression-Free
Survival
Efficacy Signal Seen in High Folate Receptor Alpha Patients;
Additional Analyses to be Conducted
Favorable Tolerability Profile Confirmed
Combination Regimens to be Evaluated as an Independent Path
Forward to Support Registration in Ovarian Cancer
Conference Call to be Held at 8 a.m. ET
ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced that its Phase 3 FORWARD I trial evaluating the
safety and efficacy of mirvetuximab soravtansine compared to
chemotherapy in patients with folate receptor alpha (FRα)-positive,
platinum-resistant ovarian cancer did not meet its primary endpoint
of progression-free survival (PFS) in either the entire study
population or in the pre-specified subset of patients with high FRα
expression.
“Even though FORWARD I did not meet its primary endpoint, I
continue to be impressed with the efficacy and tolerability of
mirvetuximab soravtansine in ovarian cancer patients, especially in
the subset with high FRα expression,” said Dr. Kathleen Moore,
Associate Director of Clinical Research at the Stephenson Cancer
Center at the University of Oklahoma. “I look forward to continuing
to work with ImmunoGen to analyze the Phase 3 data and determine
the most appropriate path to bringing mirvetuximab soravtansine to
those patients who benefit most from it.”
The FORWARD I Phase 3 trial randomized 366 patients 2:1 to
receive either mirvetuximab soravtansine or the physician's choice
of single-agent chemotherapy (pegylated liposomal doxorubicin,
topotecan, or weekly paclitaxel). Eligibility criteria included
patients with platinum-resistant ovarian cancer that expressed
medium or high levels of FRα who have been treated with up to three
prior regimens. The primary endpoint of this study was PFS, which
was assessed using the Hochberg procedure in the entire study
population and in the subset of patients with high FRα expression.
The Hochberg procedure enables the simultaneous testing of two
overlapping populations. Under this statistical analysis plan, if
the p-value of the primary endpoint in either population is greater
than 0.05, the p-value in the other population needs to be less
than or equal to 0.025 to achieve statistical significance.
“Based upon the efficacy signals we observed in the high FRα
subset with PFS, confirmed overall response rate and overall
survival, we are conducting additional analyses to further evaluate
the potential benefit of mirvetuximab soravtansine for FRα-positive
platinum-resistant ovarian cancer,” said Anna Berkenblit, MD,
Senior Vice President and Chief Medical Officer of ImmunoGen. “We
want to thank the patients who participated in this trial, the
clinical investigators, and the support staff for their hard work,
as we continue to pursue our goal of finding innovative cancer
treatments for patients in need.”
Key findings from FORWARD I are as follows:
- In the entire study population, the
confirmed overall response rate was higher for mirvetuximab
soravtansine than for chemotherapy (22% vs 12%, p-value 0.015),
without a significant difference in the primary endpoint of PFS (HR
0.98, p-value 0.897) or overall survival (HR 0.81, p-value
0.248).
- In the pre-specified high FRα subgroup
(218/366, 60%)
- PFS was longer in patients who received
mirvetuximab soravtansine compared with chemotherapy (HR 0.69,
p-value 0.049). Given that the p-value in the entire study
population exceeded 0.05, the statistical analysis plan for the
study required the p-value in the high subset to be less than or
equal to 0.025 to achieve statistical significance.
- Confirmed overall response rate was
higher for mirvetuximab soravtansine than for chemotherapy (24% vs
10%, p-value 0.014).
- Overall survival was longer in patients
who received mirvetuximab soravtansine compared with chemotherapy
(HR 0.62, p-value 0.033).
- Mirvetuximab soravtansine was
well-tolerated, with fewer patients experiencing grade 3 or greater
adverse events (46% vs 61%), fewer dose reductions (20% vs 31%),
and fewer discontinuations due to drug-related adverse events (5%
vs 8%) compared with chemotherapy.
- The safety profile of mirvetuximab
soravtansine was confirmed, with the most common adverse events
including nausea (54% all grades; 2% grade 3 or greater), diarrhea
(44% all grades; 4% grade 3 or greater), and blurred vision (43%
all grades; 3% grade 3 or greater).
“This study with mirvetuximab did not result in the outcome that
we had hoped for in platinum-resistant patients. We will further
assess the data from FORWARD I to determine potential next steps
with a monotherapy approach. In parallel, we have generated
encouraging data with mirvetuximab combination regimens and will
evaluate our ongoing studies as an independent path forward to
support a registration in ovarian cancer,” said Mark Enyedy,
ImmunoGen’s President and Chief Executive Officer. “ImmunoGen is in
a strong financial position with approximately $295 million in cash
on our balance sheet, and we will continue to advance our portfolio
of next-generation ADCs, which includes three additional
development candidates targeting a range of tumor types in both
hematologic malignancies and solid tumors.”
ImmunoGen intends to present additional results from FORWARD I
at an upcoming medical meeting.
CONFERENCE CALL INFORMATIONImmunoGen will host a
conference call on March 1, 2019 at 8 a.m. ET to discuss the
top-line findings from the FORWARD I trial. To access the live call
by phone, dial 334-323-0522; the conference ID is 7188781. 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 March 15.
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. This trial was intended
to support full marketing approval of mirvetuximab soravtansine for
patients with platinum-resistant ovarian cancer.
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.
This press release includes forward-looking statements based on
management's current expectations. These statements include, but
are not limited to, ImmunoGen’s plan to further assess the data
from FORWARD I, ImmunoGen’s expectations with respect to the future
development of mirvetuximab soravtansine as a monotherapy or in
combination regimens, ImmunoGen’s plan to advance its portfolio of
next-generation ADCs, ImmunoGen's ability to expand the addressable
patient population for mirvetuximab soravtansine and the regulatory
and commercial potential of mirvetuximab combinations in earlier
lines of therapy. 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. It should be noted that there are risks and
uncertainties related to the development of novel anticancer
products, including risks related to preclinical and clinical
studies, their timings and results, and the potential that earlier
clinical studies may not be predictive of future results. A review
of these risks can be found in ImmunoGen's Annual Report on Form
10-K for the year ended December 31, 2017 and other reports filed
with the Securities and Exchange Commission.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190301005092/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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