ImmunoGen Presents Initial Data from FORWARD II Expansion Cohort Assessing Mirvetuximab Soravtansine in Combination with KEYT...
October 20 2018 - 6:30AM
Business Wire
Preliminary Data Demonstrate Favorable Safety Profile and
Encouraging Activity in Heavily Pretreated Patients with Ovarian
Cancer
ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced initial safety and preliminary anti-tumor activity
from the FORWARD II expansion cohort assessing mirvetuximab
soravtansine in combination with Merck’s anti-PD-1 therapy,
KEYTRUDA® (pembrolizumab). The data are being presented at the
European Society for Medical Oncology (ESMO) 2018 Congress, which
is being held October 19-23, in Munich, Germany.
“A high unmet need exists in patients with platinum-resistant
ovarian cancer, particularly for heavily pretreated patients, and
the goal of this study is to assess whether the addition of a
checkpoint inhibitor prolongs the clinical benefit of mirvetuximab
soravtansine in later-line patients through concomitant activation
of the immune system,” said Ursula Matulonis, M.D., Chief, Division
of Gynecologic Oncology, Dana-Farber Cancer Institute. “Preliminary
activity seen with the mirvetuximab soravtansine and pembrolizumab
combination is encouraging, especially when considering other
combinations involving pembrolizumab used in this patient
population, where recent clinical trials have reported overall
response rates below 20 percent.”
The data presented at ESMO were for 56 patients with
platinum-resistant ovarian cancer, of whom 40 have medium or high
folate receptor alpha (FRα) expression. Patients had received a
median of 3 prior therapies (range 2-7).
The combination of mirvetuximab soravtansine (6 mg/kg adjusted
ideal body weight) and pembrolizumab (200 mg, supplied by Merck)
demonstrates favorable tolerability and encouraging activity.
Adverse events were predominantly mild to moderate (≤ Grade 2),
consistent with the known safety profiles of each agent.
Preliminary findings related to activity include:
- 83% of patients (45/54 with at least
one post-baseline scan) experienced tumor shrinkage of target
lesions in response to treatment with mirvetuximab soravtansine and
pembrolizumab, with more robust reductions observed in patients
with tumors expressing FRα at medium or high levels.
- Confirmed partial responses (PRs) were
observed in 16 patients, with another 9 patients having unconfirmed
PRs at the time of data analysis.
- In the subset of patients with medium
or high FRα expression levels, the confirmed overall response rate
(ORR) was 31 percent (95% CI, 17, 48), with a median
progression-free survival (PFS) of 5.5 months (95% CI 2.8, 6.3) and
a median duration (DOR) of 8.1 months (95% CI 4.2, upper bound not
yet reached).
- At the time of analysis, the data were
immature with 16 patients still on study (all with medium or high
FRα expression) and a median follow-up of 8.3 months.
- For all patients evaluable for
activity, the confirmed ORR was 30 percent (95% CI 18, 44), with a
median PFS of 4.2 months (95% CI 2.8, 5.9). The median DOR data of
6.9 months (95% CI 4.2, 8.3) suggest a trend towards improvement
over mirvetuximab soravtansine monotherapy.
“The combination of mirvetuximab soravtansine with pembrolizumab
continues to demonstrate a favorable tolerability profile in women
with platinum-resistant ovarian cancer, with preliminary activity
consistent with mirvetuximab monotherapy in heavily pretreated
patients,” said Anna Berkenblit, M.D., Vice President and Chief
Medical Officer of ImmunoGen. “The early duration of response data
from the expansion cohort suggest a trend towards improvement over
mirvetuximab monotherapy. As the data from this cohort continue to
mature, we will use it to guide the further development of this
novel combination, as part of our broader strategy to establish
mirvetuximab soravtansine as the preferred combination therapy in
ovarian cancer.”
POSTER PRESENTATION DETAILS
- Title: “Mirvetuximab
soravtansine, a folate receptor alpha (FRα-targeting antibody-drug
conjugate (ADC), with pembrolizumab in platinum-resistant ovarian
cancer (PROC): Initial results of an expansion cohort from FORWARD
II, a Phase Ib study” (abstract #949P)
- Date: October 20, 2018
- Time: 12:30 CEST
- Lead author: Ursula Matulonis,
M.D., Chief, Division of Gynecologic Oncology, Dana-Farber Cancer
Institute, Boston, MA
Additional information can be found at www.esmo.org.
About FORWARD IIFORWARD II is a Phase 1b/2 study of
mirvetuximab soravtansine in combination with
AVASTIN® (bevacizumab), or KEYTRUDA® (pembrolizumab) in
patients with FRα-positive platinum-resistant ovarian
cancer, primary peritoneal, or fallopian tube tumors, as well as a
combination with carboplatin and a triplet combination of
mirvetuximab plus carboplatin and AVASTIN in patients with
platinum-sensitive 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.” Our
lead product candidate, mirvetuximab soravtansine, is in a Phase 3
study for folate receptor alpha (FRα)-positive platinum resistant
ovarian cancer, and in Phase 1b/2 testing in combination regimens.
Our novel IGN candidates for hematologic malignancies, IMGN779 and
IMGN632, are in Phase 1 studies.
Learn more about who we are, what we do, and how we do it at
www.immunogen.com.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
AVASTIN® is a registered trademark of Genentech, Inc., a member of
the Roche Group.
This press release includes forward-looking statements based on
management's current expectations. These statements include, but
are not limited to, 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 fiscal year ended December 31, 2017 and other reports
filed with the Securities and Exchange Commission.
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Investor Relations ContactImmunoGen, Inc.Sarah Kiely,
781-895-0600sarah.kiely@immunogen.comorMedia
ContactImmunoGen, Inc.Courtney O’Konek,
781-895-0600courtney.okonek@immunogen.comorFTI ConsultingRobert
Stanislaro, 212-850-5657robert.stanislaro@fticonsulting.com
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