ImmunoGen Presents Data from FORWARD II Assessment of Mirvetuximab Soravtansine in Combination with Pembrolizumab at the Soci...
March 24 2018 - 6:00PM
Business Wire
Dose Finding Data Demonstrate Encouraging Signs
of Efficacy and a Favorable Safety Profile in Platinum-Resistant
Ovarian Cancer
Most Significant Benefit Seen Among Patients
with Medium and High Folate Receptor Alpha Expression Levels –
Expansion Cohort for this Population Enrolling
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced encouraging efficacy and favorable tolerability
data from the FORWARD II cohort assessing mirvetuximab soravtansine
in combination with Merck’s anti-PD-1 therapy pembrolizumab in
patients with platinum-resistant epithelial ovarian cancer (EOC).
These data are being presented at the Society of Gynecologic
Oncology (SGO) Annual Meeting, March 24-27, 2018 in New Orleans,
LA.
Key findings in 14 heavily pre-treated patients are as
follows:
- In the subset of 8 patients with medium
or high folate receptor alpha (FRα) expression levels, the
confirmed overall response rate (ORR) was 63 percent (95% CI 25,
92), with a median progression-free survival (PFS) of 8.6 months
(95% CI 1.6, upper bound not yet reached).
- For all patients, the confirmed ORR was
43 percent (95% CI 18, 71), with a median PFS of 5.2 months (95% CI
1.6, 9.5); patients in this cohort had received a median of 4.5
prior lines of systemic therapy, with 64% of patients receiving 4
or more prior lines.
- As previously reported, at full dosing,
the combination of mirvetuximab (6 mg/kg) and pembrolizumab (200
mg, supplied by Merck) demonstrates favorable tolerability,
consistent with the known safety profiles of each agent, with
primarily mild to moderate (≤ grade 2) adverse events
observed.
Based on these data, ImmunoGen is enrolling an additional 35
patients with medium or high FRα expression levels in an expansion
cohort in the FORWARD II study.
“We are encouraged by the early evidence of anti-tumor activity
with durable responses and the tolerability profile of mirvetuximab
in combination with pembrolizumab, particularly among the subset of
patients with medium or high folate receptor alpha expression where
we saw the greatest benefit,” said Anna Berkenblit, M.D., Vice
President and Chief Medical Officer of ImmunoGen. “Across multiple
combinations, we’ve demonstrated that our Phase 3 single agent dose
level for mirvetuximab combines readily with other therapies. The
consistency of these findings further underscore the potential of
mirvetuximab for ovarian cancer – both as monotherapy, and in
combination with other therapies in earlier lines of
treatment.”
Featured Poster Presentation Details
Title: "Initial safety and activity findings from a phase 1b
escalation study of mirvetuximab soravtansine, a folate receptor
alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination
with pembrolizumab in platinum-resistant epithelial ovarian cancer
(EOC) patients" (abstract #74)
Lead author: Ursula Matulonis, M.D., Director and Program
Leader, Gynecologic Oncology Program, Dana-Farber Cancer Institute,
Boston, MA
The findings will be presented during featured poster
presentation discussion sessions:
- Sunday, March 25 at 3:30pm CT
- Monday, March 26 at 3:30pm CT
Additional information can be found at www.sgo.org
About FORWARD IIFORWARD II is a Phase 1b/2 study of
mirvetuximab in combination with Avastin® (bevacizumab), pegylated
liposomal doxorubicin, or Keytruda® (pembrolizumab) in patients
with FRα-positive platinum-resistant EOC, primary peritoneal, or
fallopian tube tumors, as well as a doublet combination of
mirvetuximab 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 FRα-targeting ADC. It uses a 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, Inc.ImmunoGen is a clinical-stage
biotechnology company that develops targeted cancer therapeutics
using its proprietary ADC technology. The Company’s lead product
candidate, mirvetuximab soravtansine, is in the Phase 3 FORWARD I
trial for FRα-positive platinum-resistant ovarian cancer, and is in
the Phase 1b/2 FORWARD II trial in combination regimens for
earlier-stage disease. ImmunoGen has three additional
clinical-stage product candidates, two of which are being developed
in collaboration with Jazz Pharmaceuticals. ImmunoGen's ADC
technology is also used in Roche's marketed product, Kadcyla®, and
in programs in development by Amgen, Bayer, Biotest, CytomX,
Debiopharm, Lilly, Novartis, Sanofi and Takeda. More information
about the Company can be found at www.immunogen.com.
Keytruda®, Avastin® and Kadcyla® are registered trademarks of
their respective owners.
This press release includes forward-looking statements. 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. It should be noted that
there are risks and uncertainties related to the development of
novel anticancer products, including mirvetuximab soravtansine, and
risks related to preclinical and clinical studies, their timings
and results. A review of these risks can be found in ImmunoGen's
Annual Report on Form 10-K for the year ended December 31,
2017 and other reports filed with the Securities and
Exchange Commission.
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version on businesswire.com: https://www.businesswire.com/news/home/20180324005001/en/
For InvestorsImmunoGen, Inc.Sarah Kiely,
781-895-0600sarah.kiely@immunogen.comorFor MediaImmunoGen,
Inc.Courtney O’Konek,
781-895-0600courtney.okonek@immunogen.comorFTI Consulting
Inc.Robert Stanislaro,
212-850-5657robert.stanislaro@fticonsulting.com
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