Addition of Epratuzumab to Combination Chemotherapy May be Beneficial in Acute Lymphocytic Leukemia
Epratuzumab Combined With Clofarabine and Cytarabine Produced a Complete Response Rate of 50%
Clofarabine and Cytarabine Demonstrated a Complete Response Rate of 17% in a Previous Study
ATLANTA, Dec. 10, 2012 (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 adult patients with relapsed or refractory acute lymphocytic leukemia (ALL) reported a complete response (CR and CRi) rate of 50% after receiving one cycle of treatment with epratuzumab in combination with the chemotherapy agents, clofarabine and cytarabine.
Results from this Phase II S0910 study conducted by the Southwest Oncology Group (SWOG) of the National Cancer Institute (NCI) were presented at the 2012 Annual Meeting of the American Society of Hematology by Anjali S. Advani, MD, Principal Investigator and staff physician in the Department of the Hematologic Oncology and Blood Disorders at Cleveland Clinic's Taussig Cancer Institute, Cleveland, OH.
In addition to Cleveland Clinic, other clinical research centers participating in this multicenter trial include City of Hope National Medical Center, Duarte, CA; Stanford University School of Medicine, Stanford, CA; University of Mississippi, Jackson, MS; University of Rochester Medical Center, Rochester, NY; Baylor College of Medicine, Houston, TX; Fred Hutchinson Cancer Research Center, and SWOG Statistical Center, Seattle, WA.
SWOG had previously reported a CR rate of 17% in adult patients with ALL using only the combination of clofarabine and cytarabine. Because virtually all immature B cells express CD22, which is the target of the Company's proprietary humanized antibody, epratuzumab, the NCI-study group wanted to evaluate the CR rate of combining the anti-CD22 antibody with the two chemotherapeutic agents.
Twenty patients were initially accrued into the study to test
whether the CR rate is sufficiently high to warrant further
investigation.
After at least 2 complete responders were observed in the first 20
patients, an additional 12 patients were accrued.
Among the 32 eligible patients evaluated, the overall CR rate
was 50% (95% CI 32-68%), including 10 CRs and 6 CRis. The null
response rate in this protocol was 10%, and the P-value comparing
50% to 10% is 1.2 x
10-8 (P=0.000000012).
The median overall survival for the 32 eligible patients with
follow-up information was 4 months. Only 5 patients who achieved
CR/CRi had their bone marrow tested for minimal residual disease
(MRD). Of these, only 1 patient achieved a significant MRD response
and this patient survived
11 months.
"We are very pleased with the encouraging complete response rate reported by SWOG," commented Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. "We continue to add value to epratuzumab by supporting its use in oncology indications by outside, independent investigators. The anti-CD22 antibody will be evaluated in a large multicenter European trial by the IntreALL Inter-European study group in combination with chemotherapy in pediatric patients with relapsed ALL, using event-free survival as the primary endpoint," added Ms. Sullivan.
About Immunomedics
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(TM) (DNL(TM)) 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 209 active patents in the United States and more than
400 foreign patents, protects our product candidates and
technologies. 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
ccheng@immunomedics.com
Posted: December 2012
