BeiGene (NASDAQ:BGNE) presents preliminary data from multiple disease-specific subgroups in the ongoing Phase 1A/1B trial of its investigational anti-PD-1 antibody BGB-A317. The data were presented at ESMO in Madrid.
The three posters contained preliminary data from patients with gastric cancer (GC) and esophageal cancer (EC), head and neck squamous cell carcinoma (HNSCC), and ovarian cancer (OC), respectively. The preliminary Phase 1 data suggest that BGB-A317 was generally well tolerated and exhibited preliminary evidence of anti-tumor activity in advanced patients with each of these tumor types.
Preliminary Results in GC and EC: The data presented were from 83 patients with advanced or metastatic GC (46 patients) or EC (37 patients) treated with BGB-A317 at 2 mg/kg or 5 mg/kg Q2W or Q3W. At the time of the data cutoff, median treatment duration was 45 days for patients with GC and 50 days for patients with EC.
At the time of the data cutoff, the efficacy-evaluable population included 34 GC patients and 31 EC patients. Among GC patients, four achieved a confirmed partial response (PR) and three achieved stable disease (SD). Among EC patients, two achieved a confirmed PR and nine achieved SD. Three of the nine patients with EC who achieved SD also achieved an unconfirmed PR, including one who awaits response confirmation. At the time of the data cutoff, 27 patients remained on treatment.
Preliminary Results in HNSCC: The data presented were from 18 patients treated with BGB-A317 at 5 mg/kg Q3W. At the time of the data cutoff, median treatment duration was 104 days. Of the 17 efficacy-evaluable HNSCC patients, three achieved a confirmed PR and six achieved SD. At the time of the data cutoff, three patients remained on treatment.
Preliminary Results in OC: The data presented were from 51 patients treated with BGB-A317 at different dose levels (0.5 to 10 mg/kg Q2W in dose escalation, 2 or 5 mg/kg Q2W or Q3W or 200 mg Q3W in dose expansion, or 5 mg/kg Q3W in indication expansion). At the time of the data cutoff, median treatment duration was 71 days. Of the 50 efficacy-evaluable OC patients, two achieved a confirmed PR and 20 achieved SD. At the time of the data cutoff, six patients remained on treatment.
BGB-A317 is an investigational humanized monoclonal antibody that binds to (inhibits) a cancer cell surface protein called PD-1 which downregulates the immune system (same mechanism of action as Bristol-Myers' Opdivo and Merck's Keytruda).
Now read: Ignyta: Buy The Dip »
Subscribe for full text news in your inbox