ImmunoGen, Inc. Announces Favorable STARLYTE Phase II Clinical Data with Sanofi’s SAR3419 in Diffuse Large B-Cell Lymphoma
02 June 2014 - 1:24AM
Business Wire
- SAR3419 achieved objective responses
well above the study threshold and was found to have a favorable
safety profile.
- Objective responses reported in
patients whose disease had not responded to prior therapy.
- Selected for Best of ASCO.
ImmunoGen, Inc. (NASDAQ: IMGN), a biotechnology company that
develops novel anticancer therapeutics using its antibody-drug
conjugate (ADC) technology, today announced the presentation of
favorable clinical findings with SAR3419 (coltuximab ravtansine)
from the STARLYTE Phase II trial in diffuse large B-cell lymphoma
(DLBCL). SAR3419 is a CD19-targeting ADC developed by ImmunoGen and
licensed to Sanofi as part of a broader collaboration between the
companies. The study results were reported in an oral abstract
session at the American Society of Clinical Oncology (ASCO) 50th
Annual Meeting being held in Chicago, IL; they were also selected
for Best of ASCO (abstract #8506).
In the data presented today, study investigators reported
achievement of proof of concept, with 43.9% objective response rate
(ORR) for the per protocol population (patients with relapsed or
relapsed/refractory disease). The primary objective of the study
was to assess whether single agent SAR3419 could achieve an ORR of
at least 20% in this patient population using Cheson 2007 criteria.
Additionally, objective responses were reported among the patients
enrolled with primary refractory disease – cancer that had not
responded to first-line treatment – with a 21.4% ORR.
“SAR3419 demonstrated promising activity against previously
treated DLBCL, including disease that had not responded to
first-line treatment,” commented Daniel Junius, president and CEO
of ImmunoGen. “We believe the unique profile of SAR3419 can make an
important difference for patients with DLBCL, and potentially for
other types of B-cell malignancies. These data also add to the
growing body of favorable findings with ADCs using our
technology.”
The STARLYTE trial is evaluating the efficacy and safety of
SAR3419 used as a single agent to treat relapsed or
relapsed/refractory CD19-positive DLBCL. Patients received SAR3419
at 55 mg/m2 weekly for four weeks and then every other week
until disease progression or discontinuation. Of the patients
enrolled in the trial, 55 were evaluable for efficacy and 61 were
evaluable for safety.
The 41 per protocol patients included 26 patients with relapsed
but not refractory disease and 15 patients with disease refractory
to their last treatment. Among these patients:
- The ORR was 53.8% among the patients
with relapsed disease, with 69.2% having stable disease or better.
The 14 patients with objective responses included 5 patients with
complete responses (CRs) and 9 patients with partial responses
(PRs).
- Among the 15 patients with disease
refractory to the last treatment, the ORR was 26.7%, with 46.7%
having stable disease or better. These included 1 CR and 3
PRs.
The 55 efficacy evaluable patients also included 14 individuals
with primary refractory disease. Among these patients, the ORR was
21.4%, with 35.7% having stable disease or better. The objective
responses reported included 1 CR as well as 2 PRs.
The investigators reported that SAR3419 was found to have a
favorable safety profile, with few treatment-related grade 3/4
adverse events (AEs) or serious AEs reported. No grade 3 or 4
peripheral neuropathy or ocular events were observed; any ocular
events were low grade (1 or 2), manageable and reversible. Moderate
hematological toxicities were reported including anemia,
thrombocytopenia and neutropenia.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics. The
Company’s ADC technology uses tumor-targeting antibodies to deliver
an ImmunoGen cell-killing agent specifically to cancer cells; the
Company has also developed antibodies with anticancer activity of
their own. The first product with ImmunoGen’s ADC technology is
Roche’s Kadcyla®. ImmunoGen has three wholly owned product
candidates in clinical testing with additional compounds in
clinical testing through the Company’s partnerships with Amgen,
Bayer HealthCare, Biotest and Sanofi. More information about
ImmunoGen can be found at www.immunogen.com.
Kadcyla® is a registered trademark of Genentech, a member of the
Roche Group.
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 SAR3419, including 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 fiscal year ended June 30, 2013 and
other reports filed with the Securities and Exchange
Commission.
For Investors:ImmunoGen, Inc.Carol Hausner,
781-895-0600info@immunogen.comorFor Media:Pure Communications,
Inc.Dan Budwick, 973-271-6085
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