Sacituzumab Govitecan Produced Overall Response Rate of 31 Percent in Patients Post Endocrine Treatment with a Manageable Safety Profile
Full Data will be Reported in Oral Presentation at 2018 American Society of
Clinical Oncology (ASCO) Annual Meeting
Company to Host Investor Event on June 3, 2018
MORRIS PLAINS, N.J., May 16, 2018 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (IMMU) (“Immunomedics” or the “Company”), a science-based and innovation-focused biopharmaceutical company committed to the development and worldwide commercialization of its unique and proprietary antibody-drug conjugate (ADC) platform, today announced that sacituzumab govitecan, its lead investigational ADC, induced promising objective responses as a single agent in heavily pre-treated patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC).
“For women with HR+ metastatic breast cancer relapsing after endocrine treatment, there are currently limited treatment options,” said Aditya Bardia, MD, MPH, Director of Precision Medicine and attending physician at Center for Breast Cancer, Massachusetts General Hospital, Harvard Medical School, Boston, MA and lead author of the abstract. “I am very encouraged with the results of sacituzumab govitecan in this subgroup of patients with metastatic breast cancer.”
As reported in the ASCO abstract released online on May 16th, 2018, sacituzumab govitecan generated a confirmed overall response rate (ORR) of 31 percent in heavily pre-treated ER+/HER2- mBC patients (N = 54), based on local assessment. The six-month clinical benefit rate was 48 percent.
“We are extremely encouraged to see that our unique ADC is showing promise as a treatment for the ER+/HER2- subgroup, providing further evidence in establishing sacituzumab govitecan as a foundational therapy for metastatic breast cancer,” said Dr. Robert Iannone, Head of Research & Development and Chief Medical Officer of Immunomedics.
Sacituzumab govitecan treatment was generally well tolerated, with no treatment-related deaths. Consistent with safety data obtained in metastatic TNBC, grade 3 or 4 toxicity with greater than 10 percent frequency included neutropenia and leukopenia. There was one case of grade 3/4 diarrhea and febrile neutropenia.
Additional findings, including durability of responses and patient sub-group analyses will be presented in an oral session at 9:12 a.m. (Central Time) on Sunday, June 3, 2018 at the ASCO meeting:
- Efficacy of sacituzumab govitecan (anti-Trop-2-SN-38 antibody-drug conjugate) for treatment-refractory hormone-receptor positive (HR+)/HER2-negative metastatic breast cancer (mBC) (Bardia, et al.)
Session Title: Breast Cancer – Metastatic
Abstract # 1004
9:12 a.m. - 9:24 a.m. (Central Time)
On June 3, 2018, Immunomedics will host an investor event at 7:30 p.m. Central Time at the McCormick Place Convention Center in Chicago, IL. For additional information and/or to RSVP for the event, please contact Dr. Chau Cheng at firstname.lastname@example.org. The investor event will be webcast via the Investors page on the Company’s website at https://immunomedics.com/investors/.
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer and other serious diseases. Immunomedics’ corporate objective is to become a fully-integrated biopharmaceutical company and a leader in the field of antibody-drug conjugates. For additional information on the Company, please visit its website at https://immunomedics.com/. The information on its website does not, however, form a part of this press release.
Cautionary note regarding forward-looking statements
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, anticipated patient enrollment, trial outcomes, timing or associated costs), regulatory applications and related timelines, including the anticipated filing timeline for the BLA, out-licensing arrangements, forecasts of future operating results, potential collaborations, capital raising activities, and the timing for bringing any product candidate to market, 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, the Company’s dependence on business collaborations or availability of required financing from capital markets, or other sources on acceptable terms, if at all, in order to further develop our products and finance our operations, new product development (including clinical trials outcome and regulatory requirements/actions), 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 the Company’s ability to repay its outstanding indebtedness, if and when required, 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.