China National Medical Products Administration Approves BeiGene’s Tislelizumab for Patients with Classical Hodgkin’s Lymphoma Who Have Received at Least Two Prior Therapies
BeiGene-discovered drug to receive regulatory approval, first in China
- Tislelizumab is an anti–PD-1 antibody specifically designed to minimize binding to FcγR on macrophages
“We’ve been working to develop improved therapies for cancer patients around the world. The discovery of immunotherapy revolutionized the cancer treatment paradigm and has since brought new treatment options and hope to people with cancer,” commented
In addition, a supplementary new drug application (sNDA) for tislelizumab in patients with previously treated locally advanced or metastatic urothelial carcinoma has been accepted and granted priority review by the
Tislelizumab is a biologic product approved under the Marketing Authorization Holder (MAH) pilot program in
The NMPA approval is based on the clinical results from a single-arm, multi-center, pivotal Phase 2 trial BGB-A317-203 (NCT03209973). Among the patients who were evaluable for responses, with a minimum follow-up of 12 months and a median follow-up of 14 months, the independent review committee (IRC)-assessed objective response rate (ORR) was 76.9% and the complete response (CR) rate was 61.5%.
In the R/R cHL trial BGB-A317-203, the most common adverse reactions (≥ 10%) reported were pyrexia, hypothyroidism, weight increase, pruritus, decreased white blood cell count, upper respiratory tract infection, increased alanine aminotransferase (ALT), rash, decreased neutrophil count, cough, fatigue, and increased blood bilirubin. Grade 3 and above adverse reactions occurring in ≥ 2% of patients included pneumonitis, weight increase, severe skin reactions and hypertension. There was no fatal adverse reaction case reported from BGB-A317-203.
Like other immune checkpoint inhibitors, tislelizumab could cause immune- related adverse events (irAE) that mainly include pneumonitis, diarrhea and colitis, hepatitis, endocrinopathies (hypothyroidism, hyperthyroidism and other thyroid disorders, adrenocortical insufficiency, hyperglycemia and type 1 diabetes mellitus) and skin adverse reactions. Occasionally, nephritis, pancreatitis, myocarditis and other irAE 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.
About Classical Hodgkin’s Lymphoma
Hodgkin’s lymphoma is a group of malignancies that affects the lymph nodes and the tissues of the lymphatic system. The most common form is classical Hodgkin’s lymphoma (cHL), which accounts for 95% of all Hodgkin’s lymphoma incidences1. It is most commonly diagnosed in young adults between the ages of 15 and 35 and in older adults over age 552. Enlarged lymph nodes are typically the initial symptom, but cancer cells can be detected in liver, spleen, and bone marrow in late stage disease. Although first-line chemo-radiotherapy has demonstrated significant improvement in the survival of patients with cHL, patients with primary refractory disease (approximately 5-10%) or those who relapse after responding to initial treatment (approximately 10-30%), usually have poor prognosis and traditional treatments have shown limited efficacy, representing an unmet medical need.
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 will be manufactured by Boehringer Ingelheim at its facility in
Tislelizumab is being studied in a broad clinical program as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. Currently, 15 registration-enabling clinical trials are being conducted in
Tislelizumab is not approved for use outside
About the Tislelizumab Clinical Program
Clinical trials of tislelizumab include:
- Phase 2 trial in patients with locally advanced or metastatic urothelial bladder cancer (NCT04004221);
- Phase 3 trial in patient 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);
- 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, 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
Liza Heapes or Vivian Ni
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1 Weber JS, D’Angelo SP, Minor D, et al. Lancet Oncol. 2015;16(4):375–384. doi:10.1016/S1470-2045(15)70076-8
2 Ansell SM. Am J Hematol. 2012;87(12):1096–1103. doi:10.1002/ajh.23348
3 ABRAXANE® is registered trademark of
Source: BeiGene, LTD.