CHICAGO, June 06, 2016 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (Nasdaq:IMMU) today announced that sacituzumab govitecan (IMMU-132), its lead investigational antibody-drug conjugate (ADC), shrank tumors by 30% or more initially in 26% (12/46) of evaluable patients with metastatic non-small-cell lung cancer (NSCLC), with a later confirmed overall objective response rate (ORR) of 13%, in accordance with RECIST 1.1 criteria. For the patients with confirmed responses, the duration of response (DOR) was 9 months.
Interim median progression-free survival (PFS) and overall survival (OS) were 3.9 months (95% confidence interval [CI]; 3.4, 6.9) and 10.5 months (95% CI; 5.8, 10.5), respectively. Significant tumor shrinkage and disease stabilization was observed in both adenocarcinoma and squamous cell carcinomas, the two major subtypes of NSCLC, and in patients who had failed previous anti-PD-1/PD-L1 therapy.
Sacituzumab govitecan directs SN-38, the active moiety of irinotecan, preferentially towards tumor cells by using an antibody targeted against Trop-2 – a commonly expressed surface marker on epithelial cancers. At the recommended dose of 10 mg/kg given intravenously on days 1 and 8 of 21-day repeated cycles, sacituzumab govitecan had a manageable safety profile in the absence of mandated growth factor, anti-nausea and anti-diarrheal prophylaxis, with 29% Grades 3 and 4 neutropenia as the major toxicity and minimal (7%) Grade 3 and 4 diarrhea, which, historically, has been a major side-effect with irinotecan.
“Any interpretation of either the efficacy or safety data on IMMU-132 in lung cancer patients from this trial has to take into account that the patients had a median of 3 prior therapies. In such a heavily-pretreated population and because prophylactic supportive care was not part of the protocol from Cycle 1, the safety data on this drug is really quite striking. Some people need dose reductions, but in general it’s a pretty easy drug to give. While the severe neutropenia rate is comparable, the severe diarrhea rate is less than a third of that seen with irinotecan in previous studies in lung cancer conducted in the pure second line setting,”1 commented D. Ross Camidge, MD, PhD, Joyce Zeff Chair in Lung Cancer Research at the University of Colorado Cancer Center, who presented these results at the Clinical Science Symposium on Raising the Bar for Targeted Therapies for Lung Cancers of the 2016 Annual Meeting of the American Society of Clinical Oncology (ASCO). “While the confirmed response rate is modest at 13%, the duration of these responses to date is impressive, over double that seen with irinotecan alone in the same historical lung cancer studies.”
Dr. Camidge also updated the results from 12 patients who had prior anti-PD-1/PD-L1 therapies. Eight of these patients showed either stable disease or partial responses with sacituzumab govitecan, including one patient with squamous cancer achieving a partial response, awaiting confirmation.
“The potential for non-overlapping cross-resistance with anti-PD-1/PD-L1 therapy is intriguing and suggests several paths forward for this drug in the era of routine immunotherapy,” remarked Dr. Camidge.
“We are very encouraged with these results from IMMU-132, especially in patients relapsing or not responding to checkpoint-inhibitor therapy, which may allow for combinational therapies to improve treatment outcomes,” remarked Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics.
Dr. Wells A. Messersmith, a colleague of Dr. Camidge at the University of Colorado Cancer Center, also participated in this multicenter study. Other Investigators include Drs. Rebecca Heist and Aditya Bardia, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA; Drs. Gregory A. Masters and Michael J. Guarino, Helen F. Graham Cancer Center & Research Institute, Newark, DE; Drs. Ronald J. Scheff and Allyson J. Ocean, Weill Cornell Medical College, New York, NY; Dr. Alexander N. Starodub, Indiana University Health Center for Cancer Care, Goshen, IN; and Drs. Leora Horn and Jordan D. Berlin, Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, TN.
- Georgoulias V, Kouroussis C, Agelidou A, et al. Irinotecan plus gemcitabine vs irinotecan for the second-line treatment of patients with advanced non-small-cell lung cancer pretreated with docetaxel and cisplatin: a multicentre, randomised, phase II study. British Journal of Cancer 91:482–488, 2004.
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer, autoimmune disorders and other serious diseases. Immunomedics’ advanced proprietary technologies allow the Company to create humanized antibodies that can be used either alone in unlabeled or “naked” form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins. Using these technologies, Immunomedics has built a pipeline of eight clinical-stage product candidates. Immunomedics’ portfolio of investigational products includes antibody-drug conjugates (ADCs) that are designed to deliver a specific payload of a chemotherapeutic directly to the tumor while reducing overall toxic effects that are usually found with conventional administration of these chemotherapeutic agents. Immunomedics’ most advanced ADCs are sacituzumab govitecan (IMMU-132) and labetuzumab govitecan (IMMU-130), which are in Phase 2 trials for a number of solid tumors and metastatic colorectal cancer, respectively. IMMU-132 has received Breakthrough Therapy Designation from FDA for the treatment of patients with triple-negative breast cancer who have failed at least two prior therapies for metastatic disease. Immunomedics has a research collaboration with Bayer to study epratuzumab as a thorium-227-labeled antibody. Immunomedics has other ongoing collaborations in oncology with independent cancer study groups. The IntreALL Inter-European study group is conducting a large, randomized Phase 3 trial combining epratuzumab with chemotherapy in children with relapsed acute lymphoblastic leukemia at clinical sites in Australia, Europe, and Israel. Immunomedics also has a number of other product candidates that target solid tumors and hematologic malignancies, as well as other diseases, in various stages of clinical and preclinical development. These include combination therapies involving its antibody-drug conjugates, bispecific antibodies targeting cancers and infectious diseases as T-cell redirecting immunotherapies, as well as bispecific antibodies for next-generation cancer and autoimmune disease therapies, created using its patented DOCK-AND-LOCK® protein conjugation technology. The Company believes that its portfolio of intellectual property, which includes approximately 288 active patents in the United States and more than 400 foreign patents, protects its product candidates and technologies. For additional information on the Company, please visit its website at www.immunomedics.com. The information on its 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 (including the funding therefor, outcomes, timing or associated costs), 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, new product development (including clinical trials outcome and regulatory requirements/actions), the Company’s dependence on business collaborations in order to further develop our products and finance our operations, the risk that we or any of our collaborators may be unable to secure regulatory approval of and market our drug candidates, risks associated with the outcome of pending litigation and 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.
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