Date: 2018-08-09
Type of
information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: BeiGene (China)
Product: tislelizumab (BGB-A317)
Action
mechanism:
- monoclonal antibody/immune checkpoint inhibitor. BGB-A317 is an investigational humanized monoclonal antibody designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of various cancers.
- Tislelizumab is also being studied in global Phase 3 trials in solid tumors, including second-line NSCLC, first-line hepatocellular carcinoma, and second-line esophageal squamous cell carcinoma; two global Phase 2 trials in previously treated advanced hepatocellular carcinoma and relapsed/refractory mature T- and natural killer-cell lymphomas; a Phase 3 trial in China in non-squamous NSCLC; and two pivotal Phase 2 trials in China in relapsed/refractory classical Hodgkin's lymphoma and second-line urothelial cancer.
Disease: Stage IIIB or IV squamous non-small cell lung cancer (NSCLC).
Therapeutic
area: Cancer - Oncology
Country: China
Trial
details:
- This open-label, randomized, multicenter Phase 3 study is designed to compare the efficacy and safety of Tislelizumab combined with chemotherapy versus chemotherapy only as first-line treatment in advanced Squamous NSCLC. 45 sites will be involved in China, 342 subjects will be enrolled. (NCT03594747)
Latest
news:
- • On August 9, 2018, BeiGene announced that the first patient was dosed in a Phase 3 clinical trial of tislelizumab, an investigational anti-PD-1 antibody, combined with chemotherapy, as a potential first-line treatment in China for patients with Stage IIIB or IV squamous non-small cell lung cancer (NSCLC).
- The Phase 3, open-label, multi-center trial is expected to enroll approximately 340 chemotherapy naïve patients with Stage IIIB or IV squamous NSCLC in mainland China who will be randomized to receive i) carboplatin and paclitaxel, ii) carboplatin, paclitaxel and tislelizumab, or iii) carboplatin, nab-paclitaxel (ABRAXANE, which is commercialized by BeiGene in China) and tislelizumab. The trial is designed to compare progression-free survival (PFS) as assessed by the Independent Review Committee (IRC) per RECIST v1.1. Key secondary endpoints include overall survival, overall response rate, duration of response, PFS by investigator assessment, and safety and tolerability.
Is
general: Yes
