ImmunoGen, Inc. Announces Encouraging IMGN529 Clinical Data Presented at 56th ASH Annual Meeting and Exposition
07 December 2014 - 4:01AM
Business Wire
- IMGN529 achieved objective responses in
four of ten (40%) evaluable patients with heavily pretreated
diffuse large B-cell lymphoma (DLBCL) – including a complete
response – at the dose levels evaluated to date.
- Dose finding is ongoing, with the
maximum tolerated dose (MTD) not yet established.
ImmunoGen, Inc. (NASDAQ: IMGN), a
biotechnology company that develops novel anticancer therapeutics
using its antibody-drug conjugate (ADC) technology, today announced
the presentation of encouraging clinical findings with its IMGN529
experimental therapy for B-cell malignancies at the American
Society of Hematology (ASH) annual meeting (abstract #1760). These
include objective responses at doses that were generally well
tolerated.
ImmunoGen’s IMGN529 is a potential new treatment for DLBCL and
other non-Hodgkin lymphoma (NHL) subtypes. An ADC, it comprises an
antibody that targets CD37, found on B-cell malignancies, with the
potent cancer cell-killing agent, DM1, attached. The antibody
serves to deliver the DM1 specifically to B cells to kill them and,
based on preclinical research, also contributes anticancer
activity.1
IMGN529 is currently in the dose-finding portion of a Phase I
clinical trial, which assesses increasing doses of this
experimental therapy in new groups of patients with
relapsed/refractory NHL. Findings with the first doses evaluated
were reported previously.2
Clinical Data Presented
The IMGN529 dose levels evaluated to date range from 0.1 to 1.4
mg/kg, administered once every three weeks. Its MTD has not yet
been established, and evaluation of the 1.4 mg/kg level is
ongoing.
Twenty four (24) of the 33 patients enrolled to date were
evaluable for efficacy. Ten evaluable patients had DLBCL, which had
been heavily pretreated, and four (40%) of these patients had an
objective response: one had a complete response (CR) and three had
partial responses (PRs). The CR and one of the PRs were among
patients treated with 1.0 mg/kg, the highest IMGN529 dose level to
complete evaluation to date. Both of these patients had received
multiple prior treatments, including autologous stem cell
transplant (ASCT). Ten of the 24 evaluable patients had follicular
lymphoma and one of these patients also had a PR. This patient,
too, had received multiple treatments including ASCT.
As reported previously, an early onset, transient drop in
neutrophil counts was seen in several patients receiving IMGN529 at
low doses.2 This was believed to be due to a redistribution of the
neutrophils – induced by antibody-mediated cytokine release –
rather than to bone marrow suppression; subsequent preclinical
research supports this hypothesis (see abstract #3119).
With the addition of peri-infusional steroids to the treatment
protocol, the incidence and severity of neutropenia decreased
markedly and dose escalation resumed. As reported previously, the
first patients treated with 1.0 mg/kg had delayed onset neutropenia
or febrile neutropenia.2 G-CSF was subsequently added to the
treatment protocol and there have been no new reports of febrile
neutropenia at doses of 1.0 or 1.4 mg/kg; the one incidence of high
grade neutropenia seen with 1.4 mg/kg was of short (2 day)
duration.
Hematologic side effects are not unexpected in such heavily
pretreated patients. Other frequent side effects were fever,
fatigue, nausea, and diarrhea, which were typically Grade 1/2.
“It is encouraging that patients with such heavily pretreated
disease responded to IMGN529,” commented Dr. Charles Morris, EVP
and Chief Development Officer. “We are particularly pleased with
the responses seen in the patients with diffuse large B-cell
lymphoma given the limited treatment options for such patients
today, and look forward to advancing IMGN529 into disease-specific
testing in 2015.”
About Diffuse Large B-cell Lymphoma (DLBCL)
More than 70,000 people will be diagnosed with non-Hodgkin
lymphoma (NHL) in the US in 2014.3 DLBCL is an aggressive lymphoma
that represents approximately one third of the new NHL cases
diagnosed annually.3
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.
1Deckert et al. Blood, 2013 Nov 14; 122(20):3500-10.
2ASCO annual meeting 2014; abstract #8526.
3American Cancer Society (2014), Cancer Facts &
Figures.
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 IMGN529, 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, 2014 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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