Date: 2015-11-09
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
Company: Celgene (USA - NJ)
Product: brontictuzumab (Anti-Notch1, OMP-52M51)
Action
mechanism: monoclonal antibody. Brontictuzumab (Anti-Notch1, OMP-52M51) is a novel anti-cancer stem cell antibody that binds the Notch1 receptor. Blocking Notch1 has been shown in preclinical models to inhibit cancer stem cell growth, and promote cell differentiation, as well as to disrupt tumor angiogenesis. Brontictuzumab is being studied as a single agent in two ongoing Phase 1a clinical trials among patients with advanced solid tumors or hematologic malignancies. Both trials incorporate strong predictive biomarker hypotheses for the identification of patients more likely to respond to brontictuzumab.
Disease: solid tumors
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On November 9, 2015, OncoMed Pharmaceuticals presented clinical data related to brontictuzumab (anti-Notch1, OMP-52M51) at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. Data covered safety, biomarker and anti-tumor activity of brontictuzumab. Among the data presented were Phase 1a clinical trial results for brontictuzumab in patients with advanced solid tumors. Brontictuzumab demonstrated single-agent activity in a biomarker-selected refractory patient population. Among 15 patients whose tumors overexpressed the activated form of Notch1, as measured by .OncoMed's proprietary immunohistochemistry (IHC) test, eight patients achieved stable disease or partial response for an overall clinical benefit rate of 53 percent. Anti-tumor activity was observed in adenoid cystic carcinoma, colorectal cancer and HER2 negative breast cancer. Partial responses were observed in two patients with adenoid cystic carcinoma after just one dose of brontictuzumab. Among patients whose tumors measured high in Notch1 activation, five have survived 100 days or longer as of the data cut off. There are five additional Notch1 high patients that are currently ongoing on the study and OncoMed plans to present follow-up data on those patients when the data matures. In biomarker negative subjects, only one of 11 had clinical benefit (9%). Brontictuzumab was generally well tolerated, with the most common adverse event being on-target, manageable diarrhea. Notch pathway and cancer stem cell pathway markers were reduced in serial tumor biopsies and in surrogate patient samples (blood) at doses above 1.5 mg/kg every three weeks. The single agent Phase 2 dose of brontictuzumab was established as 1.5mg/kg every three weeks.
