SAR3419 Phase I Study Results in non-Hodgkin’s Lymphoma at ASH
December 07 2009 - 4:15PM
Business Wire
ImmunoGen, Inc. (Nasdaq: IMGN), a biopharmaceutical company that
develops targeted anticancer therapeutics, today announced the
presentation of encouraging initial clinical findings with SAR3419
at the American Society of Hematology (ASH) 51st Annual
Meeting and Exposition. Among the findings reported were responses
to SAR3419 – administered as a single agent – among patients with
B-cell non-Hodgkin's lymphoma that is refractory to treatment with
rituximab (Rituxan®).
SAR3419 is an investigational compound designed to target and
kill cancer cells that express the protein, CD19, on their surface.
The compound is in development by sanofi-aventis for the treatment
of relapsed/refractory CD19-expressing non-Hodgkin’s lymphoma and
other B-cell malignancies. ImmunoGen created SAR3419 using its
Targeted Antibody Payload (TAP) technology and licensed it to
sanofi-aventis as part of a broader collaboration.
The study found that 17 of 27 (63%) patients who were
response-evaluable at the time of data cut-off for presentation
experienced a reduction in tumor size (7% to 86% reduction). These
included 7 of 14 (50%) patients who had disease that was refractory
to treatment with rituximab.
Five patients had an objective response, all of whom received
SAR3419 at its maximum tolerated dose (MTD) or the next highest or
lowest dose. Among these responders was a patient with
rituximab-refractory disease. All but one of these five patients
reached the best response either during the last treatment cycle
allowed under the study protocol (cycle 6) or after their last dose
of SAR3419. This is consistent with the observation that the best
response to treatment typically occurred after a patient had
received several doses of SAR3419.
A primary endpoint of the study was to establish the MTD of
SAR3419 when administered once every three weeks. This was
determined to be 160 mg/m2. Additional patients will receive
SAR3419 at this dose to gain more information on the tolerability
and activity of the compound when administered at its MTD. A Phase
I study also is underway to assess weekly dosing of SAR3419.
“These initial findings support that SAR3419 offers potential
for the treatment of B-cell non-Hodgkin’s lymphoma, including
rituximab-refractory disease,” commented John Lambert, PhD,
Executive Vice President and Chief Scientific Officer, ImmunoGen.
“SAR3419 has demonstrated evidence of activity at doses that were
well tolerated. Of particular note, the compound wasn’t associated
with toxicities that would limit its ability to be evaluated as
part of a combination regimen in future studies, if desired. We
look forward to seeing the findings from the expansion phase of
this trial as well as from the weekly-dosing study.”
About the Presentation
The presentation, “Phase I Multi-Dose Escalation Study of the
Anti-CD19 Maytansinoid Immunoconjugate SAR3419 Administered by
Intravenous (IV) Infusion Every 3 Weeks to Patients with
Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma (NHL)” (abstract
#585) was given by Anas Younes, MD, Professor of Medicine and
Director, Clinical Investigation and Translational Research,
Department of Lymphoma/Myeloma at the MD Anderson Cancer
Center.
About the Study
Patients received SAR3419 by intravenous infusion once every 3
weeks at dose levels ranging from 10-270 mg/m2. The dose-limiting
toxicity was found to be manageable and reversible corneal
toxicity. SAR3419 was generally well-tolerated and was not
associated with any significant hematological toxicity that would
limit its ability to be used in combination with other agents.
A total of 38 patients had been enrolled at the time of data
cut-off for presentation. These patients all had CD19-expressing
B-cell non-Hodgkin's lymphoma that had either returned following
treatment (relapsed) or was unresponsive to treatment (refractory).
Seventeen of these patients had follicular lymphoma, 10 had small
lymphocytic lymphoma, 5 had mantle cell lymphoma, 2 had marginal
zone lymphoma and 4 had diffuse large B-cell lymphoma. They all had
received prior treatment with rituximab, a monoclonal antibody that
targets B-cells expressing CD20. Nine patients had undergone stem
cell transplantation after prior drug and/or radiation therapy.
There were no restrictions on the number or types of prior
treatment regimens the patients may have received.
About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma is a cancer that starts in lymphocytes, a
type of white blood cell which is part of the body's immune system.
Non-Hodgkin’s lymphoma can occur at any age and is often marked by
enlarged lymph nodes, fever, and weight loss. There are many
different types of non-Hodgkin’s lymphoma. These types can be
divided into aggressive (fast-growing) and indolent (slow-growing)
types, and they can be formed from either B lymphocytes (B-cells)
or T lymphocytes (T-cells). Lymphomas that occur after bone marrow
or stem cell transplantation are usually B-cell non-Hodgkin’s
lymphomas. Although both B and T lymphocytes can develop into
lymphoma cells, B-cell lymphomas are much more common than T-cell
lymphomas, and make up about 85 percent of non-Hodgkin’s
lymphomas diagnosed in the US. Prognosis and treatment of
non-Hodgkin’s lymphomas depend on the stage and type of
disease.
In 2009, about 453,000 people are living with non-Hodgkin’s
lymphoma or are in remission. It is estimated that approximately
66,000 new cases of non-Hodgkin’s lymphoma will be diagnosed in the
US this year, and 19,500 people will die from the disease.
About ImmunoGen, Inc.
ImmunoGen, Inc. develops targeted anticancer therapeutics using
its expertise in cancer biology, monoclonal antibodies and the
creation and attachment of potent cancer-cell killing agents. The
Company’s Targeted Antibody Payload (TAP) technology uses
antibodies to deliver one of ImmunoGen’s proprietary cancer-cell
killing agents specifically to tumors. In addition to the Company’s
product pipeline, compounds utilizing the TAP technology are in
clinical testing through ImmunoGen’s collaborations with Genentech
(a wholly-owned member of the Roche Group), sanofi-aventis, Biogen
Idec and Biotest. The most advanced compound, trastuzumab-DM1
(T-DM1), is in Phase III testing being conducted by Genentech
and Roche. Other ImmunoGen collaborative partners include Bayer
HealthCare and Amgen. More information about ImmunoGen can be found
at www.immunogen.com.
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 uncertainties around clinical trials conducted and 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, 2009 and other reports filed with the Securities and
Exchange Commission.
Revlimid® is a registered trademark of
Celgene Corporation.
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