ImmunoGen Presents Final Data From Phase 1b FORWARD II Triplet Cohort Evaluating Mirvetuximab Soravtansine in Combination Wit...
September 17 2020 - 3:01AM
Business Wire
Triplet Combination Demonstrates Encouraging Anti-Tumor Activity
and Tolerability in Recurrent Platinum-Sensitive Ovarian Cancer
ImmunoGen, Inc., (Nasdaq: IMGN) a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced final data from the FORWARD II triplet cohort
evaluating mirvetuximab soravtansine in combination with
carboplatin and Avastin® (bevacizumab) in patients with folate
receptor alpha (FRα)-positive recurrent, platinum-sensitive ovarian
cancer at the European Society for Medical Oncology (ESMO) 2020
Virtual Congress.
“Although there have been advances in the treatment of
platinum-sensitive disease with targeted and maintenance therapies,
there remains a significant need for additional active,
well-tolerated combinations in the platinum-sensitive setting,”
said David O'Malley, MD, Professor, Director of Gynecologic
Oncology and Co-Director, Gynecologic Oncology Phase 1 Program at
The Ohio State University and the James Cancer Center, and FORWARD
II Principal Investigator. “The efficacy outcomes demonstrated by
combining full dose mirvetuximab with bevacizumab and carboplatin
in more heavily pretreated platinum-sensitive ovarian cancer
patients is encouraging relative to current standard of care
triplet regimens.”
In the FORWARD II triplet cohort Phase 1b trial, 41 patients
with a median age of 63 years received the combination of full dose
mirvetuximab with carboplatin and bevacizumab. Eligibility criteria
included patients with recurrent platinum-sensitive ovarian cancer
that expressed medium or high levels of FRα, who had been treated
with up to two prior lines of therapy. 73% of patients had one
prior line of therapy and 27% had two prior lines of therapy, while
42% of patients had received prior PARP inhibitors, and 24% had
received prior treatment with bevacizumab.
Key Findings from FORWARD II Triplet Cohort
- In 41 patients with recurrent platinum-sensitive ovarian cancer
with medium or high levels of FRα who have received up to two prior
lines of therapy, the confirmed overall response rate (ORR) for the
triplet was 83%, with a median duration of response (DOR) of 10.9
months and median progression free survival (PFS) of 12.8
months.
- These efficacy outcomes are encouraging relative to those
reported in less heavily pretreated patient populations for other
carboplatin and bevacizumab-based triplets.
- Mirvetuximab was readily combined and well tolerated with
standard dosing of carboplatin and bevacizumab, with a manageable
adverse event (AE) profile as anticipated for this triplet based on
the side effect profiles of each agent. Thrombocytopenia, a common
adverse event with carboplatin treatment, was the most common cause
of drug-related discontinuations.
- Post-carboplatin (median 6 cycles), mirvetuximab soravtansine
and bevacizumab continuation/maintenance was well tolerated.
“Having generated a wealth of data demonstrating encouraging
efficacy and favorable tolerability, mirvetuximab continues to show
promise in combination – not only as a triplet but also when
combined with bevacizumab or carboplatin as a doublet. In the
future, we look forward to defining a formal path to registration
for mirvetuximab in combination with approved agents with the goal
of expanding use into earlier lines of therapy and becoming the
combination agent of choice in ovarian cancer,” said Anna
Berkenblit, MD, Senior Vice President and Chief Medical Officer of
ImmunoGen.
ESMO Poster Details
In addition, the City of Hope will present data from their study
of mirvetuximab in combination with gemcitabine in patients with
recurrent FRα-positive ovarian cancer, endometrial cancer, and
triple negative breast cancer.
- Title: “A Phase I Study of Mirvetuximab Soravtansine
(MIRV) and Gemcitabine (G) in Patients (Pts) with Selected
FRα-positive Solid Tumors: Results in the Endometrial Cancer (EC)
Cohort” (Presentation #863P)
- Date: Thursday, September 17, 2020
- Time: 9:00 a.m. CEST/3:00 a.m. ET
- Lead Author: Mihaela C. Cristea, MD, Associate Clinical
Professor, Department of Medical Oncology and Therapeutics
Research, Gynecologic Oncology Peritoneal Malignancy Program, City
of Hope Comprehensive Cancer Care Center
Additional information can be found at www.esmo.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 folate receptor alpha
(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 a first-in-class 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
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.”
Learn more about who we are, what we do, and how we do it at
www.immunogen.com.
Avastin® and Keytruda® are registered trademark 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 pre-clinical,
clinical, and regulatory events related to ImmunoGen’s product
candidates; and the presentation of pre-clinical and 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 pre-clinical and 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200917005172/en/
INVESTOR RELATIONS AND MEDIA ImmunoGen Courtney O’Konek
781-895-0600 courtney.okonek@immunogen.com OR FTI Consulting
Robert Stanislaro 212-850-5657
robert.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
