Updated Phase 2 Results in Metastatic Triple-Negative Breast Cancer to be Presented at The 2018 San Antonio Breast Cancer Symposium (SABCS) Continue to Show Meaningful Clinical Benefit Consistent with Prior Results
Pivotal Randomized Study in Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2-Negative (HER2–) Metastatic Breast Cancer (mBC)
Immunomedics, Inc., (NASDAQ: IMMU) (“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.
| mTNBC (N=108) Local Assessment | mTNBC (N=108) BICR Assessment | |
| Response# | ||
| Objective response, n (%) | 36 (33) | 37 (34) |
| Complete response, n (%) | 3 (3) | 7 (7) |
| Partial response, n (%) | 33 (31) | 30 (28) |
| Clinical benefit rate (CBR)*, n (%) | 49 (45) | |
| Duration of response (DoR), months, median | 7.7 | 9.1 |
| # Data cutoff as of December 1, 2017. Previously reported efficacy data with a June 30, 2017 data cutoff included ORR=33% (local), 32% (BICR) and median DoR=8.3 months (local), 6.7 months (BICR). * Clinical benefit rate=complete response + partial response + stable disease ≥6 months | ||
“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.
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