MORRIS PLAINS, N.J., June 03, 2016 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (Nasdaq:IMMU) today announced that the Company was advised late yesterday that its abstract, “Therapy of refractory/relapsed metastatic triple-negative breast cancer (mTNBC) with an anti-Τrop-2-SN-38 antibody-drug conjugate (ADC), sacituzumab govitecan (IMMU-132): Phase II results,” planned for oral presentation today and selected by the American Society of Clinical Oncology (ASCO) for its Press Briefing, was cancelled because of a complaint that the Company violated the embargo by reporting results presented by its Chairman at a conference in April. It appears the complaint was made by a third party contacting ASCO. No question was raised on the quality of the results.
Immunomedics President and Chief Executive Officer, Cynthia L. Sullivan, remarked: “The presenter, Dr. Bardia, and I are attempting to reverse this with ASCO, because we believe the patient population and results reported in April were different from those in the ASCO abstract submitted last February. Both we and our many investigators involved are disappointed that our excellent therapeutic results, achieving an interim median survival of about 14 months, may not be presented at this meeting. These results are very encouraging for TNBC patients with metastatic disease who failed multiple prior therapies.”
Sacituzumab govitecan continues to provide a promising median survival benefit in 60 assessable patients with mTNBC who had received a median of 5 (range, 2 – 12) prior lines of therapy. As of May 2016, the objective response rate (ORR) for this group of patients was 33% (confirmed ORR was 28%), which nearly doubled what has been reported with standard-of-care in this late-stage setting, and the median duration of response was almost 11 months. Median progression-free survival was 5.6 months, which is almost twice as long as conventional therapy, based on historical data,1-6 and median overall survival was 14.3 months. The major toxicity was neutropenia, which was manageable, and did not result in cessation of therapy.
These results were discussed with the U.S. Food and Drug Administration (FDA) during a recent Breakthrough Therapy Designation (BTD) follow-on meeting. Sacituzumab govitecan has previously received BTD from the FDA for the treatment of patients with TNBC who have failed at least two prior therapies after their cancer has metastasized. After receiving guidance from the regulatory authority, the Company plans to pursue accelerated approval for sacituzumab govitecan as a treatment for patients with TNBC in this setting. The application for Accelerated approval will be based on the ongoing Phase 2 trial with efficacy data, expanding the patient population over the next few months. In addition, a confirmatory Phase 3 clinical study based upon the Special Protocol Assessment (SPA) trial design that the FDA agreed in December 2015 is planned to begin patient enrollment by the end of this calendar year.
The company plans to publish the Phase 2 study results in a peer-reviewed medical or cancer journal as soon as possible, so that the medical community can have full access to the clinical trial findings.
- Mancini P, Angeloni A, Risi E, et al. Standard of care and promising new agents for triple-negative metastatic breast cancer. Cancers (Basel) 2014.
- Andre F, Zielinski CC. Optimal strategies for the treatment of metastatic triple-negative breast cancer with currently approved agents. Ann Oncol 2012.
- Perez E.A., Patel T. and Moreno-Aspitia A. Efficacy of ixbepilone in ER/PR/HER-2 negative (triple-negative) breast cancer. Breast Cancer Res Treat 2010.
- O’Shaughnessy J, Lee Schwartzberg L, Danso MA, et al. Phase III Study of iniparib plus gemcitabine and carboplatin versus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer. J Clin Oncol 2014.
- Forero-Torres A, Varley KE, Abramson VG, et al. TBCRC 019: A phase II trial of nanoparticle albumin-bound paclitaxel with or without the anti-death receptor 5 monoclonal antibody tigatuzumab in patients with triple negative breast cancer. Clin. Cancer Res. 2015.
- Isakoff SJ, Mayer EL, Lei H, et al. TBCRC009: A multicenter phase II clinical trial of platinum monotherapy with biomarker assessment in metastatic triple-negative breast cancer. J Clin Oncol 2015.
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 2 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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