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.
Barbara Jacoby is an award winning blogger that has contributed her writings to multiple online publications that have touched readers worldwide.