BeiGene Announces Positive Topline Results for Global Phase 3 Trial of Tislelizumab in Esophageal Squamous Cell Carcinoma
Jan 27, 2021 5:45 PM
Tislelizumab prolonged the survival of patients with advanced unresectable or metastatic ESCC who received prior systemic treatment compared to chemotherapy
Safety findings of tislelizumab were consistent with known risks
“We are excited to announce the improved overall survival observed in another Phase 3 trial for tislelizumab when compared to chemotherapy standard of care. This is our fourth positive Phase 3 readout for tislelizumab and the first from our large Phase 3 program in gastrointestinal cancers that also include liver, stomach cancers as well as esophageal cancer,” commented
“Esophageal cancer represents a significant unmet medical need with rapid progression and high mortality. Recent years have seen a paradigm-shift in advanced ESCC treatment from chemotherapy and radiation to immunotherapy. The positive topline results from the RATIONALE 302 trial demonstrated that tislelizumab may offer a new treatment option for those living with this devastating disease and bring hope to patients and their families,” said
RATIONALE 302 Trial of Tislelizumab Versus Chemotherapy in Advanced ESCC
RATIONALE 302 is a randomized, open-label, multicenter global Phase 3 trial (NCT03430843) designed to evaluate the efficacy and safety of tislelizumab when compared to investigator’s choice chemotherapy in patients with advanced unresectable or metastatic ESCC who have received prior systemic treatment.
The primary endpoint of the trial is OS in the ITT population. A total of 512 patients enrolled in the trial in 11 countries across
About Esophageal Squamous Cell Carcinoma (ESCC)
Esophageal squamous cell carcinoma (ESCC) is the most common subtype of esophageal cancer globally, the sixth leading cause of cancer-related death in the world.i In 2020, there were more than 600,000 new cases of esophageal cancer and approximately 550,000 deaths worldwide.ii Esophageal cancer is a rapidly fatal disease and more than two-thirds of the patients have advanced or metastatic disease at the time of diagnosis, with a median survival of eight to 10 months and an expected five-year survival rate of less than five percent.iii
About Tislelizumab
Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.
In addition, two supplemental new drug applications for tislelizumab have been accepted by the
Currently, 15 potentially registration-enabling clinical trials are being conducted in
In
Tislelizumab is not approved for use outside of
About Tislelizumab Clinical Program
Clinical trials of tislelizumab include:
- Phase 3 trial comparing tislelizumab to salvage chemotherapy in patients with relapsed/refractory classical Hodgkin Lymphoma (NCT04486391);
- Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
- Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
- 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 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 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).
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding data from the RATIONALE-302 global Phase 3 trial of tislelizumab versus chemotherapy in the second-line setting in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma, the potential implications of clinical data for patients, BeiGene’s plans to present the data at an upcoming medical conference, and
i Abbas, G., & Krasna, M. (2017). Overview of esophageal cancer. Annals of cardiothoracic surgery, 6(2), 131–136. https://doi.org/10.21037/acs.2017.03.03
ii Globocan 2020. Available at https://gco.iarc.fr/today/data/factsheets/cancers/6-Oesophagus-fact-sheet.pdf. Accessed in
iii Parkin, 1999; Lin M, 2016; Drahos J, 2013.
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