ImmunoGen Presents Initial Data at ASCO from FORWARD II Study Evaluating Mirvetuximab Soravtansine in Combination with Avasti...
May 29 2020 - 8:01AM
Business Wire
With a Confirmed Overall Response Rate of 64% and Favorable
Tolerability in Patients with High FRα Expression, Combination
Demonstrates Encouraging Outcomes Relative to Available
Regimens
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 were presented in an oral presentation at the American
Society of Clinical Oncology (ASCO) 2020 Virtual Scientific
Program.
“The data presented at ASCO demonstrate the potential of
mirvetuximab to serve as the combination agent of choice for both
platinum-sensitive and platinum-resistant recurrent ovarian
cancer,” said Anna Berkenblit, MD, Senior Vice President and Chief
Medical Officer of ImmunoGen. “We are particularly encouraged by
the overall response rate of 64% observed in patients with high FRα
expression, regardless of platinum status. We look forward to the
continued evaluation of mirvetuximab with bevacizumab in this
increasing population of recurrent ovarian cancer patients for whom
a non-platinum based regimen would be appropriate.
“Despite the advances with PARP inhibitors and anti-angiogenic
agents in newly diagnosed ovarian cancer, active, well-tolerated
therapies for women with recurrent disease regardless of platinum
status are still needed,” said Lucy Gilbert, MD, Professor, and
Director of the Gynecologic Oncology Division at McGill University
Health Center in Montreal, Canada. “With this combination, the
overall response rate in the platinum-resistant subset is more than
twice the usual response rate for this population and similarly, in
the platinum-sensitive subset, the overall response rate is higher
than previously seen with platinum-based doublets. Given these
responses and the favorable tolerability profile of this
combination, these data are exciting and demonstrate the potential
of mirvetuximab to address the growing unmet need in this patient
population.”
UPDATED DATA FROM FORWARD II DOUBLET COHORT WITH
BEVACIZUMAB
Oral Presentation, Abstract 6004
The cohort enrolled 60 patients with a median age of 60 and a
median number of 2 prior lines of therapy (range 1-4). Thirty-two
patients (53%) had platinum-resistant disease with a platinum-free
interval (PFI) of less than or equal to 6 months; 28 patients (47%)
had platinum-sensitive disease – of which 20 patients (33%) had a
PFI greater than 6 months and less than or equal to 12 months and 8
patients (13%) had a PFI greater than 12 months. The combination of
mirvetuximab with bevacizumab in this cohort demonstrates promising
anti-tumor activity with a favorable tolerability profile,
particularly among patients with high levels of FRα expression, and
is encouraging relative to outcomes with available therapies
reported in similar populations. In today’s oral presentation, key
updated data include:
- In the overall patient population, objective responses were
seen in 28 patients and the confirmed overall response rate (ORR)
was 47% (95% CI, 34, 60).
- In patients with high FRα expression (n=33), the confirmed ORR
was 64% (95% CI, 45, 80), with an ORR of 59% (95% CI, 33, 82) in
the platinum-resistant subgroup (n=17), and 69% (95% CI, 41, 89) in
the platinum-sensitive subgroup (n=16).
- With a median follow-up of 8.5 months and nearly half of
patients with high FRα expression remaining on study, the duration
of response and progression-free survival data are immature.
- The adverse events (AEs) observed with the doublet were
manageable and consistent with the side effect profiles of each
agent. The most common treatment-related AEs were low-grade,
including diarrhea, blurred vision, fatigue, and nausea; grade 3+
AEs were infrequent.
“Effective, tolerable treatment options for patients with
recurrent ovarian cancer unfortunately remain limited,” explained
David O'Malley, MD, Professor, Division Director of Gynecology
Oncology and Co-Director of the Gyn Onc Phase 1 Program, James
Cancer Center and The Ohio State University Wexner Medical Center,
and FORWARD II Principal Investigator. “These promising results
confirm previously reported mirvetuximab plus bevacizumab data
demonstrating a deeper and more durable tumor burden reduction in
women whose tumors express high levels of FRα. These results add to
the body of evidence that mirvetuximab can potentially be used to
treat a broader patient population. I look forward to further
evaluating these data as they mature.”
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® 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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