90Y-Epratuzumab Study Shows Improvement of Therapy Results Following R-CHOP
VANCOUVER, British Columbia, June 10, 2013 (GLOBE NEWSWIRE) -- Immunomedics,
Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the
development of monoclonal antibody-based products for the targeted treatment
of cancer, autoimmune and other serious diseases, today reported that adding
two doses of epratuzumab labeled with the radioisotope, yttrium-90 (^90Y), to
a combination of rituximab and CHOP chemotherapy (R-CHOP), the standard of
care for patients with diffuse large B-cell lymphoma (DLBCL), appeared to
improve elderly patients' responses to treatment.
DLBCL is the most common type of aggressive non-Hodgkin lymphoma (NHL), with
approximately 20,000 new patients diagnosed each year in the United States.
Although the standard therapy for DLBCL is R-CHOP, elderly patients who fail
R-CHOP have a poor outcome. Due to advanced age, chemo-resistant disease,
and/or concurrent co-morbid medical conditions, a significant percentage of
these patients are not eligible for high-dose salvage therapy or stem cell
transplant. Consequently, there is a need for an alternative therapy for
high-risk patients with a lower chance of being cured with standard R-CHOP.
Epratuzumab is a humanized antibody that binds to the CD22 receptor on B
cells. In various clinical trials, epratuzumab was found to be active as an
unlabeled antibody in patients with NHL or lupus. Previous clinical studies
have also demonstrated that repeated administration of small doses of
^90Y-epratuzumab (fractionated RAIT) produced high rates of durable responses
in NHL patients.^1
Results from a multicenter Phase II trial sponsored by the GOELAMS/LYSA French
study group were updated by Françoise Kraeber-Bodéré, MD, PhD, Nuclear
Medicine Department, Hôtel-Dieu University Hospital,, Nantes, France, in an
oral presentation at the Society of Nuclear Medicine and Molecular Imaging
2013 Annual Meeting. The objective of this study is to evaluate
^90Y-epratuzumab given in multiple, small doses as consolidation therapy after
R-CHOP in previously untreated elderly patients with advanced DLBCL, using
2-year event-free survival (EFS) as the primary end-point.
At the time of reporting, a total of 75 patients between the ages of 60 and 79
years had been enrolled to receive 3 cycles of R-CHOP therapy. Patients who
reported a partial response or better proceeded to receive 3 additional cycles
of R-CHOP, followed 6 – 8 weeks later by 2 once-a-week infusions of
^90Y-epratuzumab at the 15 mCi/m^2 dose level. In all, 61 patients were
eligible for the radioimmunotherapy (RIT) with ^90Y-epratuzumab.
The overall response rate (ORR) after 6 cycles of R-CHOP therapy was 94.6%
(71/75), with 52 patients (69.3%) achieving a complete or unconfirmed complete
response (CR/CRu) and 19 patients (25.3%) reporting a partial response (PR).
At a median follow-up of 27.5 months (range from 1 - 46), 18 patients had
disease progression and/or related death, yielding an estimated 2-year EFS of
75.4% (63.7 - 83.9%) and an estimated 2-year overall survival (OS) of 83.2%
(72.6 - 90.7%).
For the 61 patients who received the 2 consolidation ^90Y-epratuzumab
treatments, ORR was 91.8% (56/61), with 50 patients (81.9%) achieving a
CR/CRu. At December 2012, 12 had progression and/or related death, yielding an
estimated 2-year EFS of 79.9% (67.3 – 88.1%) and an estimated 2-year OS of
90.8% (79.2 - 96.1%). Importantly, 8 of 16 patients (50.0%) who had less than
a CR/CRu with R-CHOP converted to CR/CRu after receiving radiolabeled
"Yttrium-90-labeled-epratuzumab continues to produce encouraging clinical
results, which compare favorably with those achieved with R-CHOP alone in the
same patient population," remarked Cynthia L. Sullivan, President and Chief
Executive Officer of Immunomedics. "We are going to further develop this agent
through collaborations with outside study groups or research grants from
various funding agencies," Ms. Sullivan added.
In a separate study conducted by the French medical researchers, the value of
positron emission tomography (PET) with the fluorine-18-labeled glucose
analog, FDG, to predict progression-free survival (PFS) before and after
treatments with ^90Y-epratuzumab following R-CHOP was evaluated. PET was
performed at baseline, after 3 and 6 cycles of R-CHOP therapy, and after RIT.
Based on responses obtained from post-RIT PET imaging, 2-year PFS were 88.5%
and 57.1% in PET-negative and PET-positive patients, respectively (P = 0.006),
indicating an independent predictive value of FDG PET after RIT with
^90Y-epratuzumab. However, interim PET performed after 3 and 6 cycles of
R-CHOP did not predict PFS and is not recommended by these researchers for
early evaluation in DLBCL patients.
1.Morschhauser F., Kraeber-Bodéré F., Wegener W.A., Harousseau J.L.,
Petillon M.O., Huglo D., Trümper L.H., Meller J., Pfreundschuh M., Kirsch
C.M., Naumann R., Kropp J., Horne H., Teoh N., Le Gouill S., Bodet-Milin
C., Chatal J.F., Goldenberg D.M. High rates of durable responses with
anti-CD22 fractionated radioimmunotherapy: results of a multicenter, phase
I/II study in non-Hodgkin's lymphoma. J Clin Oncol. 2010 Aug
10;28(23):3709-16. doi: 10.1200/JCO.2009.27.7863. Epub 2010 Jul 12.
Immunomedics is a New Jersey-based biopharmaceutical company primarily focused
on the development of monoclonal antibody-based products for the targeted
treatment of cancer, autoimmune and other serious diseases.We have developed
a number of advanced proprietary technologies that allow us to create
humanized antibodies that can be used either alone in unlabeled or "naked"
form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or
toxins, in each case to create highly targeted agents.Using these
technologies, we have built a pipeline of therapeutic product candidates that
utilize several different mechanisms of action.We also have a majority
ownership in IBC Pharmaceuticals, Inc., which is developing a novel
DOCK-AND-LOCK™ (DNL™) method with us for making fusion proteins and
multifunctional antibodies, and a new method of delivering imaging and
therapeutic agents selectively to disease, especially different solid cancers
(colorectal, lung, pancreas, etc.), by proprietary, antibody-based,
pretargeting methods. We believe that our portfolio of intellectual property,
which includes approximately 223 active patents in the United States and more
than 400 foreign patents, protects our product candidates and
technologies.Our strength in intellectual property has resulted in the top-10
ranking in the 2012 IEEE Spectrum Patent Power Scorecards in the Biotechnology
and Pharmaceuticals category.For additional information on us, please visit
our website at www.immunomedics.com. The information on our website does not,
however, form a part of this press release.
This release, in addition to historical information, may contain
forward-looking statements made pursuant to the Private Securities Litigation
Reform Act of 1995. Such statements, including statements regarding clinical
trials, out-licensing arrangements (including the timing and amount of
contingent payments), forecasts of future operating results, potential
collaborations, and capital raising activities, involve significant risks and
uncertainties and actual results could differ materially from those expressed
or implied herein. Factors that could cause such differences include, but are
not limited to, risks associated with any cash payment that the Company might
receive in connection with a sublicense involving a third party and UCB, which
is not within the Company's control, new product development (including
clinical trials outcome and regulatory requirements/actions), our dependence
on our licensing partners for the further development of epratuzumab and
veltuzumab for non-cancer indications, competitive risks to marketed products
and availability of required financing and other sources of funds on
acceptable terms, if at all, as well as the risks discussed in the Company's
filings with the Securities and Exchange Commission.The Company is not under
any obligation, and the Company expressly disclaims any obligation, to update
or alter any forward-looking statements, whether as a result of new
information, future events or otherwise.
CONTACT: Dr. Chau Cheng
Senior Director, Investor Relations & Grant Management
(973) 605-8200, extension 123
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