China National Medical Products Administration Approves BeiGene’s Tislelizumab for Patients with Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma
“At BeiGene, we strive to bring innovative, impactful, and quality treatments to patients around the globe. This is our third NDA approval in the past five months for our internally developed products, a tremendous accomplishment for a young biotechnology company like
“Patients with advanced UC have limited treatment options, so we are delighted to have tislelizumab, a new immuno-oncology treatment available to them. Supported by encouraging efficacy and safety results from the trial, including an objective response rate of 24.8%, we believe tislelizumab will bring significant benefits to this patient population,” commented
“We are thrilled about today’s approval of tislelizumab in UC, which was made possible by dedicated clinicians who participated in the trial, patients who entrusted our clinical trial with their treatment, and the team at
The NMPA approval is based on the clinical results from a single-arm, multi-center pivotal Phase 2 trial of tislelizumab in patients in
The safety data for tislelizumab included in the label is based on 934 patients treated with tislelizumab monotherapy from four clinical trials, including the aforementioned pivotal Phase 2 trial in patients with UC. Most common (≥ 10%) adverse reactions included rash, fatigue, and increased alanine aminotransferase. Grade 3 or higher adverse reactions occurring in ≥ 1% of patients included: increased gamma‑glutamyl transferase, anemia, increased aspartate aminotransferase, increased alanine aminotransferase, pneumonitis, severe skin reactions, and hypokalemia.
Like other immune checkpoint inhibitors, tislelizumab could cause immune-related adverse reactions that mainly include pneumonitis, diarrhea and colitis, hepatitis, endocrinopathies (hypothyroidism, hyperthyroidism and thyroiditis, adrenocortical insufficiency, hyperglycemia and type 1 diabetes mellitus), and skin adverse reactions. Occasionally, nephritis, pancreatitis, myocarditis, myositis, and other immune-related adverse reactions were also reported.
The recommended dose of tislelizumab is 200 mg administered as an intravenous infusion every three weeks until disease progression or intolerable toxicity.
Tislelizumab is a biologic product approved under the Marketing Authorization Holder (MAH) pilot program in
About Urothelial Carcinoma
Urothelial carcinoma (UC), also known as transitional cell carcinoma (TCC), is by far the most common type of bladder cancer,1 accounting for more than 90 percent of all bladder cancers.2 Bladder cancer is the 10th most common cancer worldwide with approximately 550,000 new cases in 2018.3 In
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 as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.
Tislelizumab is approved by the
Tislelizumab is being manufactured by
Currently, 15 registration-enabling clinical trials of tislelizumab are being conducted in
Tislelizumab is not approved for use outside
About the Tislelizumab Clinical Program
Clinical trials of tislelizumab include:
- 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 non-small cell lung cancer (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 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).
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 BeiGene’s plans and expectations for the commercialization of tislelizumab, the potential implications of clinical data for patients, and BeiGene’s further advancement of, and anticipated clinical development, regulatory milestones and commercialization of tislelizumab. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including
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4 Zheng, et al.
Source: BeiGene, LTD.