Pooled analyses of Phase 1 expansion cohorts
demonstrate clinically meaningful activity in patient population
being studied in FORWARD I registration trial
Top-line data from FORWARD II indicate
favorable safety and efficacy profile in multiple combinations
Conference call scheduled for 8:00am ET on
Friday, May 19
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced promising safety and efficacy data from monotherapy
and combination studies with mirvetuximab soravtansine in patients
with folate receptor alpha (FRα)-positive epithelial ovarian cancer
(EOC). These data include results from pooled analyses of three
Phase 1 expansion cohorts and from a Phase 1b/2 study, FORWARD II,
evaluating mirvetuximab soravtansine in combination with Avastin®
(bevacizumab), carboplatin, Doxil® (pegylated liposomal
doxorubicin), or Keytruda® (pembrolizumab). These results will be
presented at the 2017 American Society of Clinical Oncology (ASCO)
Annual Meeting, which is being held June 2-7, 2017 in Chicago,
IL.
Anti-Tumor Activity and Safety Analyses in Pooled Phase 1
Expansion Cohorts
Data from the pooled analyses demonstrate the safety and
efficacy profile of mirvetuximab soravtansine in the patient
population eligible for the ongoing Phase 3 registration trial,
FORWARD I. These data include 113 EOC patients treated with
mirvetuximab soravtansine in three expansion cohorts in the Phase 1
trial. In the subset of 36 patients meeting the key eligibility
criteria for FORWARD I, which includes patients with
platinum-resistant disease and medium or high levels of FRα and who
have received up to three prior lines of therapy, the confirmed
overall response rate (ORR) was 47 percent (95% CI 30, 65) and
median progression-free survival (mPFS) was 6.7 months (95% CI 4.1,
8.3).
“The data observed with mirvetuximab compare favorably with
outcomes typically achieved with currently available single-agent
therapies for platinum resistant ovarian cancer. Current
single-agent therapies for platinum-resistant ovarian cancer have
low response rates of 15 to 20% and short median progression-free
survival of three to four months,” stated Kathleen Moore, M.D.,
Associate Professor, Department of Obstetrics and Gynecology at the
Stephenson Cancer Center at the University of Oklahoma. “Based on
the consistent safety and efficacy seen with mirvetuximab
soravtansine reflected in these pooled analyses, particularly in
those patients meeting the eligibility criteria for the pivotal
study, I am very encouraged about the potential of this compound in
patients with platinum-resistant ovarian cancer and look forward to
continued progress with the ongoing Phase 3 FORWARD I trial.”
For all 113 patients, the median number of prior regimens was 3,
85 percent had platinum-resistant disease, 67 percent had prior
bevacizumab, and 22 percent had a prior poly (ADP-ribose)
polymerase (PARP) inhibitor. The safety profile of the pooled
population was consistent with data previously reported (2016 ASCO
Annual Meeting), which consisted primarily of low grade, manageable
adverse events. In this heavily pretreated group of patients, the
confirmed ORR was 30 percent (95% CI 22, 39) and mPFS was 4.3
months (95% CI 3.9, 5.4).
Initial Safety and Preliminary Efficacy Data from FORWARD
II
FORWARD II is a Phase 1b/2 study of mirvetuximab soravtansine in
combination with Avastin®, carboplatin, Doxil® or Keytruda® in
patients with FRα-positive EOC, primary peritoneal, or fallopian
tube tumors. The data from these arms demonstrate mirvetuximab
soravtansine may complement currently available therapies for
FRα-positive EOC in a range of treatment settings, including
earlier lines of therapy.
The safety profiles for these combinations were manageable and
as expected, based on known profiles of each agent, with no new
safety signals identified. Key findings in over 60 patients from
the dose escalation phase of FORWARD II are as follows:
- Patients in the Avastin® arm were
heavily pretreated with a median of six prior regimens. The
confirmed ORR for this arm was 29 percent (95% CI 8, 58), with a
median PFS of 9.5 months (95% CI 3.5, 15.2).
- Patients with recurrent
platinum-sensitive disease on the carboplatin arm had received a
median of three prior regimens and the confirmed ORR was 65 percent
(95% CI 38, 86), with a median PFS of 12.1 months (95% CI 9.0,
15.0).
- Patients on the Doxil® arm received a
median of two prior regimens. The confirmed ORR for the Doxil® arm
was 13 percent (95% CI 2, 38), with a median PFS of 7.0 months (95%
CI 1.7, upper bound not estimated).
- Preliminary data from the Keytruda® arm
demonstrate that, similar to the other combinations, full doses of
each agent are combinable. At this time, it is too early to assess
anti-tumor activity data in this arm; anti-tumor activity will be
reported at a subsequent medical meeting.
Based on the encouraging profiles of these combinations in dose
escalation, ImmunoGen is moving forward with expansion cohorts for
Avastin® and Keytruda® and is evaluating future studies with
carboplatin combinations.
“The favorable safety profile of mirvetuximab soravtansine lends
itself well to combination, as evidenced by the data from FORWARD
II, showing the full dose of mirvetuximab soravtansine combines
with the full doses of bevacizumab (Avastin®), carboplatin,
pembrolizumab (Keytruda®) and pegylated liposomal doxorubicin
(Doxil®) in ovarian cancer,” stated David O’Malley, M.D., Associate
Professor, Director of Gynecology Clinical Trial and Phase 1
Program, James Cancer Center and The Ohio State University Wexner
Medical Center.
FORWARD I Trial
The Phase 3 FORWARD I trial was designed based on the promising
monotherapy mirvetuximab soravtansine data from the Phase 1 trial
and reflects the fastest registration strategy to obtain full
approval of mirvetuximab soravtansine as single-agent therapy.
FORWARD I is a registration trial in which 333 patients will be
randomized 2:1 and will receive either mirvetuximab soravtansine or
the physicians’ choice of therapy (Doxil®, paclitaxel, or
topotecan). The study is currently enrolling in North America and
Europe, with more than 100 sites expected to be activated in these
geographies.
“The Phase 1 expansion cohort data being presented at ASCO
support the potential of mirvetuximab soravtansine in the patient
population eligible for FORWARD I,” said Mark Enyedy, ImmunoGen's
president and chief executive officer. “With the safety and
efficacy profile demonstrated by these data, we look forward to
completing enrollment in FORWARD I and evaluating mirvetuximab
soravtansine with other therapies, including novel agents, in
earlier lines of treatment.”
ASCO Presentation Details:
Saturday, June 3, 2017
Title: Mirvetuximab soravtansine (IMGN853), a folate
receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in
platinum-resistant epithelial ovarian cancer (EOC) patients (pts):
Activity and safety analyses in phase I pooled expansion
cohorts.Presenter: Kathleen N. Moore, M.D., Associate
Professor, Department of Obstetrics and Gynecology at the
Stephenson Cancer Center at the University of OklahomaTime:
1:15pm – 4:45pm CDTLocation: Poster Board No.: 369,
Location: Hall AAbstract: 5547
Title: Safety findings from FORWARD II: A phase 1b study
evaluating the folate receptor alpha (FRα)-targeting antibody-drug
conjugate (ADC) mirvetuximab soravtansine (IMGN853) in combination
with bevacizumab, carboplatin, pegylated liposomal doxorubicin
(PLD), or pembrolizumab in patients (pts) with ovarian
cancer.Presenter: David O’Malley, M.D., Associate Professor,
Director of Gynecology Clinical Trial and Phase 1 Program, James
Cancer Center and The Ohio State University Wexner Medical
CenterTime: 1:15pm – 4:45pm CDTLocation: Poster Board
No.: 375, Location: Hall AAbstract: 5553
Title: FORWARD I (GOG 3011): A randomized phase 3 study
to evaluate the safety and efficacy of mirvetuximab soravtansine
(IMGN853) versus chemotherapy in adults with folate receptor alpha
(FRα)-positive, platinum-resistant epithelial ovarian cancer (EOC),
primary peritoneal cancer, or primary fallopian tube
cancer.Presenter: Kathleen N. Moore, M.D., Associate
Professor, Department of Obstetrics and Gynecology at the
Stephenson Cancer Center at the University of OklahomaTime:
1:15pm – 4:45pm CDTLocation: Poster Board No.: 425b,
Location: Hall AAbstract: TPS5607
Additional information - including presentation schedule and
full abstracts - can be found www.asco.org.
Conference Call Information
ImmunoGen will host a conference call on Friday, May 19 at
8:00am ET. At this briefing, ImmunoGen will discuss the data being
presented at the 2017 ASCO Annual Meeting. To access the live call
by phone, dial 719-325-2402; the conference ID is 4522749. The call
may also be accessed through the “Investors” 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
June 1, 2017.
About ImmunoGen, Inc.
ImmunoGen is a clinical-stage biotechnology company that
develops targeted cancer therapeutics using its proprietary ADC
technology. ImmunoGen's lead candidate, mirvetuximab soravtansine,
is in a Phase 3 trial for FRα-positive platinum-resistant ovarian
cancer, and is in Phase 1b/2 testing in combination regimens
for earlier-stage disease. ImmunoGen's ADC technology is used in
Roche's marketed product, Kadcyla®, in three other clinical-stage
ImmunoGen product candidates, and in programs in development by
partners Amgen, Bayer, Biotest, CytomX, Lilly, Novartis, Sanofi and
Takeda. More information about the Company can be found at
www.immunogen.com.
Avastin®, Doxil®, Keytruda® and Kadcyla® are registered
trademarks of their respective owners.
About Mirvetuximab Soravtansine
Mirvetuximab soravtansine (IMGN853) is the first FRα-targeting
ADC. It uses a 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.
This press release includes forward-looking statements. 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. It should be noted that
there are risks and uncertainties related to the development of
novel anticancer products, including mirvetuximab soravtansine,
including risks related to preclinical and clinical studies, their
timings and results. A review of these risks can be found in
ImmunoGen's Annual Report on Form 10-K for the fiscal year ended
December 31, 2016 and other reports filed with the Securities and
Exchange Commission.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170517006236/en/
For InvestorsThrust IRMonique Allaire,
617-895-9511monique@thrustir.comorFor MediaFTI Consulting,
Inc.Robert Stanislaro,
212-850-5657robert.stanislaro@fticonsulting.com
ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From Mar 2024 to Apr 2024
ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From Apr 2023 to Apr 2024