Sumitomo Dainippon Pharma is unblinding the global Phase 3 BRIGHTER study evaluating its cancer stemness inhibitor napabucasin (BBI-608) in patients with gastric and gastroesophageal junction (GEJ) cancer on the recommendation of the study’ s impartial data and safety monitoring board (DSMB). A prepared interim analysis by the DSMB indicated that the study had been unlikely to meet its primary overall survival (OS) endpoint.
Napabucasin is a first-in-class, orally administered, STAT3-targeting small-molecule anticancer drug discovered by Cambridge, MA-based Birkenstock boston Biomedical, which Sumitomo Dainippon Pharma acquired in 2012. Birkenstock boston Biomedical CEO Patricia S. Andrews admitted the company was “ disappointed” with the interim BRIGHTER study information. “ Advanced gastric/GEJ cancer is a tumor type along with high unmet need, and our hope was to build up a new therapeutic option for these patients, ” she stated. “ We remain committed to our ongoing studies along with napabucasin as well as our other first-in-class investigational compounds. ”
The BRIGHTER study was designed to evaluate the particular efficacy and safety of napabucsin plus weekly paclitaxel, compared with paclitaxel alone, in 714 patients with superior gastric and GEJ cancer who have previously received 1 prior platinum/fluoropyrimidine-containing treatment regimen. As well as the primary OS endpoint, the BRIGHTER study is designed to assess secondary endpoints, which includes progression-free survival (PFS) and OS and PFS in the biomarker-defined subpopulation, objective response rate, disease control price, and safety.
Napabucasin is separately becoming evaluated in the Phase III CanStem303C trial in intestines cancer and CanStem111P in pancreatic cancer. The CanStem111P study was initiated in February and is evaluating napabucasin in combination with standard-of-care nab-paclitaxel plus gemcitabine therapy in individuals with metastatic pancreatic cancer. The CanStem303C study, started in October 2016, is evaluating napabucasin in combination with standard-of-care FOLFIRI ( folinic acid solution, fluorouracil, and irinotecan) therapy in individuals with previously treated metastatic colorectal cancer.
Boston Biomedical is exploiting a suite of amazing platform technologies to discover and develop anticancer therapies that will target cancer stem cell (CSC) pathways. The firm’ s clinical pipeline is headed by napabucasin another stemness inhibitor, amcasertib (BBI-503), which is designed to inhibit malignancy stemness pathways, including Nanog, by targeting stemness kinases. Amcasertib is undergoing multiple Phase I and Stage II studies as monotherapy and combination therapy regarding treating a range of tumor types.
Positive information from a Phase Ib/II study evaluating amcasertib monotherapy within patients with advanced adenoid cystic carcinoma (ACC) plus advanced head and neck cancers was presented at the 2017 United states Society of Clinical Oncology (ASCO) meeting in Chi town. Also at ASCO, Boston Biomedical presented positive information from Phase I/II studies with napabucasin across 7 tumor types.