World News: 13:03 GMT Thursday 6th December 2018. [Immunomedics via Globe Newswire via SPi World News]
MORRIS PLAINS, N.J., Dec. 06, 2018 (GLOBE NEWSWIRE) -- , (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today presents updated Phase 2 results at the 2018 SABCS, confirming that monotherapy with sacituzumab govitecan achieved an objective response rate (ORR) of over 30 percent among heavily pre-treated patients with metastatic triple-negative breast cancer (mTNBC), with a manageable safety profile.
“Response rates to chemotherapy are low in patients with pre-treated mTNBC, and clinically there is a high unmet need for mTNBC patients,” commented Aditya Bardia, MD, MPH, Director of Precision Medicine and attending physician at Center for Breast Cancer, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
With an additional 5 months of follow-up for the previously reported mTNBC patient cohort, sacituzumab govitecan monotherapy continued to demonstrate robust clinical activity with an ORR of 33 percent and 34 percent based on local assessment and blinded independent central review (BICR), respectively. The key efficacy data are summarized in the table below.
“We believe these results show that sacituzumab govitecan can be a viable treatment option and help alleviate the unmet need in mTNBC,” stated Dr. Robert Iannone, Head of R&D and Chief Medical Officer of Immunomedics. “We have shared these updates with the FDA during its ongoing priority review of our Biologics License Application for accelerated approval of sacituzumab govitecan in metastatic TNBC.”
Treatment with sacituzumab govitecan was well tolerated, with a predictable and manageable safety profile, and low discontinuation rates due to adverse events. The most relevant adverse events were gastrointestinal and neutropenia, which were manageable with routine supportive care per general practice guidelines.
Below are details of the poster presentation at 2018 SABCS:
The global Phase 3 trial will enroll approximately 400 patients with HR+/HER2– mBC who have failed prior hormonal and CDK 4/6 inhibitor therapies, as well as at least 2 prior chemotherapies. The primary endpoint of this open-label study is progression free survival (PFS), with additional secondary endpoints including overall survival, CBR, health-related quality of life, and safety and tolerability.
Eligible patients will be randomized 1:1 to receive either sacituzumab govitecan or physicians’ choice of chemotherapy at clinical sites across North America and Europe. Patients will be treated until tumor progression, unacceptable toxicity, study withdrawal, or death.
Additionally, with guidance from the FDA, the protocol includes an interim analysis based on ORR that could serve as the basis for an accelerated approval submission.
As previously reported from a Phase 2 study at ASCO 2018, in 54 heavily pretreated HR+/HER2– mBC patients who had received a median of five prior treatment lines for metastatic disease, the ORR was 31 percent and the CBR was 48 percent. The median DoR was 7.4 months and the median PFS was 6.8 months, indicating that responses were durable.
Globe Newswire: 13:03 GMT Thursday 6th December 2018
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