Date: 2016-12-27
Type of information: Completion of patient enrollment
phase: 2
Announcement: completion of patient enrollment
Company: Immunomedics (USA - NJ)
Product: sacituzumab govitecan (IMMU-132)
Action
mechanism: antibody drug conjugate/ADC. Sacituzumab govitecan, or IMMU-132, is a first-in-class ADC developed by Immunomedics by conjugating the moderately-toxic drug, SN-38 (active metabolite of irinotecan), site-specifically and at a high ratio of drug to antibody, to a humanized antibody that targets the TROP-2 receptor expressed by many solid cancers. SN-38 is the active metabolite of irinotecan (Camptosar), which is used to treat certain solid cancers as a part of combination therapies, so its pharmacology and properties are well-known. IMMU-132 targets the TROP-2 antigen which is expressed on a variety of cancers. The ADC has received Fast Track designation from the FDA for the treatment of patients with triple-negative breast cancer, small-cell and non-small-cell lung cancers, and has also been designated an orphan drug for the treatment of patients with small-cell lung or pancreatic cancer in the U.S., and for the treatment of patients with pancreatic cancer in the European Union.
Disease: triple-negative breast cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On December 27, 2016, Immunomedics announced that a single-arm Phase 2 study with sacituzumab govitecan (IMMU-132) has achieved the planned enrollment of 100 patients with metastatic triple-negative breast cancer (TNBC) who have received more than one prior therapy for their metastatic disease. Cynthia L. Sullivan, President and Chief Executive Officer said, “We are delighted to have accomplished this major milestone in the clinical development of IMMU-132 in metastatic TNBC in the expected timeframe. The next step is to monitor these patients for their treatment responses, which will form part of a BLA submission planned in mid-2017 for accelerated approval in this indication.” Immunomedics is focused on achieving a number of additional critical milestones in the near-term including preparing to submit a Biological License Application (BLA) to the FDA for accelerated approval for IMMU-132 for patients with metastatic TNBC in mid-2017 and publishing Phase 2 study results with IMMU-132 in TNBC in a peer-reviewed medical journal. The company is also preparing the presentation of interim results of Phase 2 clinical trials of IMMU-132 for patients with urinary bladder cancer at the ASCO symposium on genitourinary cancers to be held in February 2017.
