ImmunoGen Announces Mature Data from FORWARD II Expansion Cohort Evaluating Mirvetuximab Soravtansine in Combination with Ava...
May 15 2019 - 5:01PM
Business Wire
Results to be Presented at 2019 ASCO Annual Meeting
Combination Demonstrates Significant Anti-Tumor Activity and
Favorable Safety and Tolerability in Platinum-Resistant Disease
Findings Support Ongoing Studies of Doublet Combination in
Platinum-Agnostic Disease and Triplet in Platinum-Sensitive
Patients
ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced mature data from the FORWARD II expansion cohort
evaluating mirvetuximab soravtansine in combination with Avastin®
(bevacizumab) in patients with folate receptor alpha (FRα)-positive
platinum-resistant ovarian cancer. These findings will be presented
at the 2019 American Society of Clinical Oncology (ASCO) Annual
Meeting, which is being held May 31 – June 4 in Chicago, IL.
“We are pleased that the combination of mirvetuximab plus
Avastin has generated significant anti-tumor activity in patients
with platinum-resistant disease, with trends toward deeper, more
durable responses seen in individuals with higher FRα expression
and a favorable tolerability profile. The outcomes observed in
patients with medium or high FRα expression are encouraging with
respect to those reported in similar patient populations for
Avastin plus chemotherapy,” said Anna Berkenblit, M.D., Vice
President and Chief Medical Officer of ImmunoGen. “Our goal remains
to establish mirvetuximab as the combination agent of choice in
ovarian cancer, supporting its use in earlier lines of therapy.
These mature data support further exploration of this doublet, as
well as the ongoing expansion study evaluating a triplet
combination of mirvetuximab with Avastin and carboplatin in
patients with platinum-sensitive disease.”
DATA FROM FORWARD II EXPANSION COHORT WITH AVASTIN
Mirvetuximab soravtansine in combination with Avastin in
patients with FRα-positive platinum-resistant ovarian cancer
continues to demonstrate anti-tumor activity with durable responses
and a favorable tolerability profile, particularly among the subset
of patients who have received up to two prior lines of therapy and
have medium or high levels of FRα expression.
Key findings in 66 patients with platinum-resistant disease
include:
- In the subset of 16 Avastin-naïve
patients with medium or high FRα expression who have received up to
two prior lines of therapy, the confirmed overall response rate
(ORR) was 56 percent (95% CI 30,80), with a median progression-free
survival (PFS) of 9.9 months (95% CI 4.1,15.9) and a median
duration of response (DOR) of 12 months (95% CI 6,14.9).
- In the overall patient population, the
confirmed ORR was 39 percent (95% CI 28,52), with a median PFS of
6.9 months (95% CI 4.9,8.6) and a median DOR of 8.6 months (95% CI
4.9, 14.9).
- The combination continues to display a
safety profile in-line with the known profiles of each agent, with
no new safety signals identified.
“Current treatment options for patients with platinum-resistant
ovarian cancer have, unfortunately, exhibited limited efficacy with
challenging side effects,” stated David O'Malley, M.D., Professor,
Director of Gynecology Clinical Trials and Phase 1 Program, James
Cancer Center and The Ohio State University Wexner Medical Center,
and FORWARD II Principal Investigator. “Final results from the
combination of mirvetuximab soravtansine and Avastin expansion
cohort demonstrate very encouraging activity and good tolerability
in platinum-resistant ovarian cancer patients, especially those
with medium or high FRα expression levels. I look forward to
further evaluating mirvetuximab in combination with Avastin as well
as in the triplet with carboplatin.”
ASCO PRESENTATION DETAILS
- Title: “Mirvetuximab
soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug
conjugate (ADC), in combination with bevacizumab in patients (pts)
with platinum-resistant ovarian cancer: Final findings from the
FORWARD II study”
- Day/Time: Saturday, June 1,
1:15pm - 4:15pm CDT and discussed at the Poster Discussion Session,
4:30pm-6pm CDT in S406
- Lead Author: David M. O’Malley,
M.D., The Ohio State University College of Medicine
- Location: Hall A
- Abstract: 5520
Initial data from an investigator-sponsored trial through the
National Comprehensive Cancer Network evaluating mirvetuximab in
combination with gemcitabine in patients with FRα-positive
recurrent epithelial ovarian, endometrial, or triple negative
breast cancer will also be presented. Full dose mirvetuximab
appears to combine well with gemcitabine, with a safety profile as
expected for these agents and with encouraging anti-tumor activity
seen in all three tumor types.
- Title: “A phase 1 study of
mirvetuximab soravtansine (IMGN853) and gemcitabine (G) in patients
with FOLR1-positive recurrent epithelial ovarian (EOC), endometrial
cancer (EC), or triple-negative breast cancer (TNBC)”
- Day/Time: Saturday, June 1,
8:00am – 11:00am CDT and discussed at the Poster Discussion
Session, 3:00pm-4:30pm CDT in E450
- Lead Author: Mihaela C. Cristea,
MD, City of Hope
- Location: Hall A
- Abstract: 3009
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 platinum-resistant or
platinum-agnostic ovarian cancer, primary peritoneal, or fallopian
tube tumors, as well as a triplet combination of mirvetuximab plus
carboplatin and Avastin in patients with platinum-sensitive ovarian
cancer.
ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab 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 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.” The Company has built a
productive platform generating a broad pipeline of ADCs targeting
solid tumors and hematologic malignancies.
Learn more about who we are, what we do, and how we do it at
www.immunogen.com.
Avastin® is a registered trademark of Genentech, a member
of the Roche Group.
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 the Company's and its
collaboration partners' product programs; and the presentation of
preclinical and clinical data on the Company’s and collaboration
partners’ 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 and the Company's collaboration partners' research and
clinical development processes; the difficulties inherent in the
development of novel pharmaceuticals, including uncertainties as to
the timing, expense and results of preclinical studies, clinical
trials and regulatory processes; ImmunoGen's ability to financially
support its product programs; ImmunoGen's dependence on
collaborative partners; industry merger and acquisition activity;
and other factors more fully described in ImmunoGen’s Annual Report
on Form 10-K for the year ended December 31, 2018 and
other reports filed with the Securities and Exchange
Commission.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190515005891/en/
INVESTOR RELATIONS CONTACTSarah
Kiely781-895-0600sarah.kiely@immunogen.com
MEDIA CONTACTCourtney
O’Konek781-895-0600courtney.okonek@immunogen.com
OR
FTI ConsultingRobert
Stanislaro212-850-5657robert.stanislaro@fticonsulting.com
ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From Apr 2024 to May 2024
ImmunoGen (NASDAQ:IMGN)
Historical Stock Chart
From May 2023 to May 2024