Epratuzumab and Rituximab Produce High Rate and Durable Progression-Free
Survival in Previously Untreated Follicular Lymphoma
-- 88.2% Overall Response Rate, Including 42.4% Complete Responses --
-- 60% of Patients Remain in Remission at 3 Years Follow-Up --
MORRIS PLAINS, N.J., Aug. 14, 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 announced that the
combination of epratuzumab and rituximab, as a front-line therapy of patients
with newly diagnosed follicular lymphoma (FL), produced a high complete
response rate and prolonged time to disease progression. Final results from
the Phase II CALGB 50701 study sponsored by the National Cancer Institute
Study Group, Cancer and Leukemia Group B (CALGB), was published online in the
The study reported an overall response rate (ORR) of 88.2% in 59 evaluable
patients who had completed all courses of treatment. Of these, 25 patients
(42.4%) achieved a complete response, 27 patients (45.8%) reported a partial
response, and 6 patients (10.2%) had stable disease as their best response.
The estimated median progression-free survival is 3.5 years. At 3 years, 60%
of patients remain in remission.
Epratuzumab is the Company's proprietary humanized anti-CD22 antibody with
strong efficacy as a monotherapy in relapsed FL.^2 Although rituximab combined
with chemotherapy has improved the survival of previously untreated patients
with FL, many patients are unable or unwilling to tolerate chemotherapy. This
has led the CALGB to evaluate the combination of epratuzumab and rituximab as
initial treatment of patients with FL, with ORR within 12 months of study
enrollment as the primary objective of the multi-institution study.
Sixty patients were enrolled by 17 CALGB institutions to receive epratuzumab
360 mg/m^2 with rituximab 375 mg/m^2 weekly for 4 induction doses. This
combination was continued as extended induction in weeks 12, 20, 28, and 36
for a total of 8 doses over 9 months. Therapy was well-tolerated, with
toxicities similar to those expected with rituximab alone.
One patient completed all courses of treatment but was not evaluable for
response because of death due to bacterial infection before the time of
response assessment. Response was assessed by computed tomography imaging.
"We are very encouraged with these high efficacy results of epratuzumab when
combined with rituximab in patients with NHL who are naive to therapy,"
remarked Cynthia L. Sullivan, President and Chief Executive Officer of
Immunomedics, Inc. "Further development of this humanized anti-CD22 antibody
will be an international Phase III study conducted by the Resistant Disease
Committee of the International BFM Study Group to improve the outcome of
children and adolescents with acute lymphoblastic leukemia," added Ms.
1.Grant BW, Jung SH, Johnson JL, Kostakoglu L, Hsi E, Byrd JC, Jones J,
Leonard JP, Martin SE, Cheson BD. A phase 2 trial of extended induction
epratuzumab and rituximab for previously untreated follicular lymphoma:
CALGB 50701. Cancer. 2013 Aug 6. doi: 10.1002/cncr.28299. Epub ahead of
print. PMID: 23922187.
2.Leonard JP, Coleman M, Ketas JC, Chadburn A, Ely S, Furman RR, Wegener WA,
Hansen HJ, Ziccardi H, Eschenberg M, Gayko U, Cesano A, Goldenberg DM.
Phase I/II trial of epratuzumab (humanized anti-CD22 antibody) in indolent
non-Hodgkin's lymphoma. J Clin Oncol. 2003 Aug 15;21(16):3051-9. Epub 2003
Jul 1. PMID: 12837807.
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. Our lead product candidate,
epratuzumab, is currently in 2 Phase III clinical trials in lupus. In
oncology, we are planning to launch a Phase III pivotal trial for clivatuzumab
labeled with a radioisotope in pancreatic cancer. Other solid tumor
therapeutics in late-stage clinical development include 2 antibody-drug
conjugates, labetuzumab-SN-38 and hRS7-SN-38. 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. We believe that our portfolio of intellectual
property, which includes approximately 227 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: For More Information:
Dr. Chau Cheng
Senior Director, Investor Relations & Grant Management
(973) 605-8200, extension 123
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