BeiGene Announces First Patient Dosed in Global Phase 3 Trial of Anti-TIGIT Antibody Ociperlimab in Non-Small Cell Lung Cancer
CAMBRIDGE, Mass. & BEIJING--(BUSINESS WIRE)--BeiGene, Ltd.?(NASDAQ: BGNE; HKEX: 06160), a global biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the first patient was dosed in the global Phase 3 AdvanTIG-302 trial of BeiGene?s investigational anti-TIGIT antibody ociperlimab (BGB-A1217) in combination with its anti-PD-1 antibody tislelizumab, for the first-line treatment of patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations. This marks the initiation of the first Phase 3 clinical trial in the planned global pivotal program for ociperlimab.
?Ociperlimab is a potent anti-TIGIT antibody with intact Fc function, which we believe to be critical for the anti-tumor activities of TIGIT antibodies. Ociperlimab is our fourth internally discovered molecule entering the pivotal stage of clinical development, and now one of the most advanced anti-TIGIT antibodies in development globally. We intend to explore the potential use of ociperlimab in additional settings and indications in our late-stage development program,? commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene. ?We hope that the AdvanTIG-302 trial will support a new and improved chemotherapy-free regimen for a significant portion of first-line patients with NSCLC and potentially other cancer patients with unmet needs.?
AdvanTIG-302 Trial of Ociperlimab in Combination with Tislelizumab in NSCLC
AdvanTIG-302 is a randomized, double-blind, multicenter, global Phase 3 clinical trial (NCT04746924), expected to enroll approximately 605 treatment-na?ve patients with locally advanced, unresectable, or metastatic NSCLC whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations in the United States, Australia and other countries and regions across the globe. Patients will be randomized to receive ociperlimab and tislelizumab combination treatment, pembrolizumab, or tislelizumab alone. The primary endpoints of the trial are progression-free survival (PFS) and overall survival (OS) in the intention-to-treat (ITT) population; secondary endpoints include safety and other efficacy endpoints.
For more information about the trial, patients and physicians should email BeiGene at?clinicaltrials@beigene.com.
About Ociperlimab (BGB-A1217)
Ociperlimab (BGB-A1217) is an investigational humanized IgG 1 monoclonal antibody discovered and being developed globally by BeiGene. An immune checkpoint molecule, BGB-A1217 is one of the most advanced anti-TIGIT antibodies in development with intact Fc function.
Targeting TIGIT provides a potential mechanism to rescue immune cells (e.g., T cells, NK cells, and dendritic cells) from the immunosuppressive tumor microenvironment, to induce an efficient antitumor immune response. The TIGIT pathway has been understood to cooperate with PD-1 to maximize the suppression of effector tumor infiltrating immune cells as well as to promote resistance to anti-PD-1 therapy. TIGIT represents a promising target with the potential to significantly improve and/or extend the therapeutic benefit of anti-PD-1 therapy to a greater number of patients.
Ociperlimab is currently being investigated in combination with tislelizumab in multiple ongoing trials, including:
- AdvanTIG-302: Phase 3 trial in untreated non-small cell lung cancer (NCT04746924);
- AdvanTIG-202: Phase 2 trial in metastatic cervical cancer (NCT04693234);
- AdvanTIG-203: Phase 2 trial in advanced esophageal squamous cell carcinoma (NCT04732494); and
- Phase 1b trial in advanced solid tumors (NCT04047862).
- Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
- Phase 3 trial comparing tislelizumab to salvage chemotherapy in patients with relapsed or refractory classical Hodgkin Lymphoma (cHL; NCT04486391);
- Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
- Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
- Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
- Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
- Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
- Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
- Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
- Phase 2 trial in patients with locally advanced or metastatic urothelial bladder cancer (NCT04004221);
- Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
- Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
- Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
- Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
- Phase 2 trial of tislelizumab in patients with relapsed or refractory cHL (NCT03209973);
- Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
- Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).