Immunomedics Announces Publication of Triple-Negative Breast Cancer Data with Sacituzumab Govitecan in the New England Journal Of Medicine
Publication Highlights Safety and Efficacy Profile of Sacituzumab Govitecan Addressing High Unmet Need in Metastatic Triple-Negative Breast Cancer
Morris Plains, N.J., February 20, 2019 — Immunomedics, Inc., (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that updated data from the Phase 2 study of sacituzumab govitecan in patients with metastatic triple-negative breast cancer (mTNBC) were published on NEJM.org as part of the February 21 print issue of the New England Journal of Medicine (NEJM).
“Patients with mTNBC have an aggressive tumor biology, and effective treatment options for previously treated patients are limited. Standard chemotherapy is associated with low responses and considerable toxicity, highlighting clinical need for better therapies,” commented Aditya Bardia, MD, MPH, lead author of the article and Director of Precision Medicine, Center for Breast Cancer, and attending physician at Massachusetts General Cancer Center, Harvard Medical School, Boston, MA. “This publication highlights a potential novel approach to treat mTNBC and improve patient outcomes, thereby creating a new treatment paradigm.”
Data from the NEJM paper showed that treatment with sacituzumab govitecan resulted in:
- An overall response rate of 33.3 percent (95% confidence interval [CI], 24.6 to 43.1) based on local assessment and 34.3 percent (95% CI, 25.4 to 44.0) based on blinded independent central review (BICR);
- A median duration of response of 7.7 months (95% CI, 4.9 to 10.8) (local assessment) and 9.1 months (95% CI, 4.6 to 11.3) (BICR);
- A median progression-free survival of 5.5 months (95% CI, 4.1 to 6.3).
Efficacy was observed in patients who had received prior taxanes and anthracyclines, suggesting a lack of cross-resistance to previous cytotoxic chemotherapy. Treatment duration with sacituzumab govitecan (5.1 months) was longer than with the immediate prior anti-tumor therapy (2.5 months), providing further evidence of clinical activity in patients with difficult-to-treat mTNBC.
TNBC accounts for 12-20 percent of all breast cancers. TNBC tumors do not have sufficient estrogen, progesterone or HER2 receptor expression to indicate the use of therapies that target these receptors. There is currently no standard-of-care chemotherapy for people with refractory mTNBC. The majority of TNBC diagnoses occur in women 51-60 years of age. The incidence rate is higher among younger women and highest among non-Hispanic black and Hispanic women.
“We are committed to becoming a leading ADC company and this publication in NEJM is a validation of our unique ADC platform,” remarked Dr. Robert Iannone, Head of Research & Development and Chief Medical Officer of Immunomedics. “To potentially broaden the use of sacituzumab govitecan for the benefit of cancer patients, we will evaluate the ADC in a number of refractory solid cancers including hormone receptor–positive breast, urothelial, non-small cell lung, and other hard-to-treat solid tumor indications, as monotherapy or in combination with immunotherapeutic and PARP-inhibiting agents.”
Sacituzumab govitecan has a predictable and manageable safety profile. The most relevant adverse events in patients with mTNBC, as well as in the larger population of patients with multiple tumor types treated with sacituzumab govitecan, were gastrointestinal and neutropenia, which were manageable with routine supportive care per general practice guidelines as evidenced by the low rate of discontinuation due to adverse events. Severe drug-related neuropathy or cardiac adverse events, which may limit the treatment duration of cytotoxic agents in this patient population, were not observed.
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer. 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 expectations for the timing or outcome of our anticipated meeting with the FDA to discuss the Complete Response Letter received in response to our BLA for sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease, and expectations for the related resubmission, the FDA re-inspection of the Company’s manufacturing facility where we manufacture the monoclonal antibody for further manufacture into our antibody-drug-conjugate candidate sacituzumab govitecan, potential approval and commercial launch of sacituzumab govitecan for that indication and the Company’s development of sacituzumab govitecan for additional indications, clinical trials (including the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs), regulatory applications and related timelines, including the filing and approval timelines for BLAs, BLA resubmissions, and BLA supplements, 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 reliance on third-party relationships and outsourcing arrangements (for example in connection with manufacturing, logistics and distribution, and sales and marketing) over which it may not always have full control, including the failure of third parties on which the Company is dependent to meet the Company’s business and operational needs for investigational or commercial products and, or to comply with the Company’s agreements or laws and regulations that impact the Company’s business; the Company’s ability to meet pre- or post-approval compliance obligations; imposition of significant post-approval regulatory requirements on our product candidates, including a requirement for a post-approval confirmatory clinical study, or failure to maintain or obtain full regulatory approval for the Company’s product candidates, if received, due to a failure to satisfy post-approval regulatory requirements, such as the submission of sufficient data from a confirmatory clinical study; the uncertainties inherent in research and development; safety and efficacy concerns related to the Company’s products and product candidates; uncertainties in the rate and degree of market acceptance of products and product candidates, if approved; inability to create an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of the Company’s product candidates, if approved; inaccuracies in the Company’s estimates of the size of the potential markets for the Company’s product candidates or limitations by regulators on the proposed treatment population for the Company’s products and product candidates; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of the Company’s products and product candidates; 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 litigation to which the Company is or may become a party, including the cost and potential reputational damage resulting from such litigation; loss of key personnel; 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.
Dr. Chau Cheng