ImmunoGen Announces Initial Data from FORWARD II Study Evaluating Mirvetuximab Soravtansine in Combination with Avastin® in ...
May 13 2020 - 5:01PM
Business Wire
Combination Demonstrates Promising Anti-Tumor Activity and
Favorable Tolerability, with a Confirmed Overall Response Rate of
>60% in Patients with High FRα Expression
Results to be Presented in an Oral Session at ASCO 2020 Virtual
Scientific Program
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced initial data from the FORWARD II study evaluating
mirvetuximab soravtansine in combination with Avastin®
(bevacizumab) in patients with medium and high folate receptor
alpha (FRα)-expressing recurrent ovarian cancer for whom a
non-platinum based combination regimen is appropriate. These
findings will be highlighted in an oral presentation at the
American Society of Clinical Oncology (ASCO) 2020 Virtual
Scientific Program on May 29, 2020. Three “trial in progress”
posters will also be presented during the meeting.
“With the benefit of the clinical profile demonstrated by
mirvetuximab monotherapy, we have pursued a development strategy to
establish mirvetuximab as the agent of choice in combination
regimens to treat expanded populations of patients with recurrent
ovarian cancer. To this end, we are encouraged by the compelling
anti-tumor activity and favorable tolerability observed with the
combination of mirvetuximab plus bevacizumab in patients for whom a
non-platinum based regimen is appropriate,” said Anna Berkenblit,
MD, Senior Vice President and Chief Medical Officer of ImmunoGen.
“These findings show greater depth and duration of tumor reduction
in women whose tumors express high levels of FRα, regardless of
platinum status, reinforcing the potential of this doublet in these
patients. As these data mature, we look forward to further
evaluating this combination in the recurrent ovarian cancer
setting.”
INITIAL DATA FROM FORWARD II DOUBLET COHORT WITH
BEVACIZUMAB This cohort enrolled 60 patients with FRα-positive
recurrent ovarian cancer for whom a non-platinum based combination
regimen is appropriate, with a median age of 60 years and a median
number of 2 prior lines of therapy (range 1-4). The combination of
mirvetuximab soravtansine with bevacizumab in this cohort
demonstrates encouraging anti-tumor activity with a favorable
tolerability profile, particularly among the subset of patients
with high levels of FRα expression.
Key findings include:
- In the overall patient population, objective responses were
seen in 26 patients and the confirmed overall response rate (ORR)
was 43% (95% CI, 31, 57).
- In patients with high FRα expression (n=33), the confirmed ORR
was 61% (95% CI, 42, 77), with an ORR of at least 50% in each of
the platinum-resistant and platinum-sensitive subgroups.
- With many patients remaining on study, the duration of response
and progression free survival data are immature.
- The adverse events (AEs) observed with the doublet were as
expected based on the side effect profiles of each agent. The most
common treatment-related low grade AEs were diarrhea, blurred
vision, nausea, and fatigue; grade 3+ AEs were infrequent, with the
most common being hypertension and neutropenia.
“With the increasing need for non-platinum regimens in recurrent
ovarian cancer, we are excited to further advance mirvetuximab in
combination with bevacizumab, building on the prior data for this
combination in women with platinum resistant disease,” stated Lucy
Gilbert, MD, Professor, and Director of the Gynecologic Oncology
Division at McGill University Health Center in Montreal, Canada.
“These initial data demonstrate meaningful clinical benefit in
women with recurrent disease, regardless of platinum status, and I
look forward to reporting longer-term follow up and further
evaluating the doublet in this expanded patient population.”
ORAL PRESENTATION SESSION
- Title: “Mirvetuximab Soravtansine, a Folate Receptor
Alpha-Targeting Antibody-Drug Conjugate, in Combination with
Bevacizumab in Patients with Platinum-Agnostic Ovarian Cancer”
- Day/Time: Friday, May 29 at 8:00 AM ET
- Lead Author: Lucy Gilbert, MD, McGill University Health
Center, Montreal, Canada
- Abstract: 6004
TRIAL IN PROGRESS POSTERS The following posters will be
available on Friday, May 29 at 8:00 AM ET in the ASCO Meeting
Library:
- Title: “MIRASOL (GOG 3045/ENGOT OV-55): A Randomized,
Open-label, Phase 3 study of Mirvetuximab Soravtansine versus
Investigator’s Choice of Chemotherapy in Advanced High-grade
Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers
with High Folate Receptor Alpha (FRα) Expression”
- Lead Author: Kathleen Moore, MD, University of Oklahoma
Health Sciences Center
- Abstract: TPS6103 (Poster 274)
- Title: “A Phase 1/2 Study of IMGN632, a Novel
CD123-Targeting Antibody-Drug Conjugate, in Patients with
Relapsed/Refractory Acute Myeloid Leukemia, Blastic Plasmacytoid
Dendritic Cell Neoplasm, and Other CD123-Positive Hematologic
Malignancies”
- Lead Author: Naval Daver, MD, MD Anderson Cancer
Center
- Abstract: TPS7563 (Poster 336)
- Title: “A Phase 1b/2 Study of the CD123-Targeting
Antibody-Drug Conjugate IMGN632 as Monotherapy or in Combination
with Venetoclax and/or Azacitidine for Patients with CD123-Positive
Acute Myeloid Leukemia”
- Lead Author: Naval Daver, MD, MD Anderson Cancer
Center
- Abstract: TPS7564 (Poster 337)
Additional information can be found at www.asco.org.
ABOUT FORWARD II FORWARD II is a Phase 1b/2 study of
mirvetuximab in combination with Avastin (bevacizumab),
carboplatin, or Keytruda (pembrolizumab) in patients with
FRα-positive recurrent epithelial ovarian, primary peritoneal, or
fallopian tube cancers, as well as a triplet combination of
mirvetuximab plus carboplatin and bevacizumab in patients with
FRα-positive platinum-sensitive ovarian cancer.
ABOUT MIRVETUXIMAB SORAVTANSINE Mirvetuximab soravtansine
(IMGN853) is an antibody-drug conjugate (ADC) comprising a folate
receptor alpha (FRα)-binding antibody, cleavable linker, and the
maytansinoid DM4, a potent tubulin-targeting agent to kill the
targeted cancer cells.
ABOUT IMMUNOGEN ImmunoGen is developing the next
generation of antibody-drug conjugates (ADCs) to improve outcomes
for cancer patients. By delivering 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®, Vidaza®, Venclexta®, and Keytruda® are registered
trademarks of their respective owners.
FORWARD-LOOKING STATEMENTS 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 clinical and regulatory events related to
ImmunoGen’s product candidates; and the presentation of clinical
data on ImmunoGen’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 timing and
outcome of ImmunoGen’s clinical development processes; the
difficulties inherent in the development of novel pharmaceuticals,
including uncertainties as to the timing, expense, and results of
pre-clinical studies, clinical trials, and regulatory processes;
ImmunoGen’s ability to financially support its product programs;
risks and uncertainties associated with the scale and duration of
the COVID-19 pandemic and resulting impact on ImmunoGen’s industry
and business; and other factors more fully described in ImmunoGen’s
Annual Report on Form 10-K for the year ended December 31, 2019 and
other reports filed with the Securities and Exchange
Commission.
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INVESTOR RELATIONS AND MEDIA CONTACTS 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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