Pharma Focus Asia

BeiGene's Tislelizumab Granted European Commission Approval for Non-Small Cell Lung Cancer Treatment

Wednesday, April 24, 2024

BeiGene, Ltd. has received approval from the European Commission (EC) for tislelizumab's usage in treating non-small cell lung cancer (NSCLC) across three distinct indications, encompassing both first and second-line applications.

Mark Lanasa, Chief Medical Officer, Solid Tumors at BeiGene, highlighted the significance of this approval, emphasizing tislelizumab's potential in addressing critical unmet needs across various tumor types, especially in NSCLC. This EC approval adds to the momentum, following recent approvals by the U.S. Food and Drug Administration for NSCLC and esophageal squamous cell carcinoma (ESCC).

The approved indications for tislelizumab are as follows:

  1. In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of adult patients with squamous NSCLC who are ineligible for surgical resection or platinum-based chemoradiation, or have metastatic NSCLC.
  2. In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of adult patients with non-squamous NSCLC whose tumors have PD-L1 expression on ≥50% of tumor cells, without EGFR or ALK positive mutations, and who are not candidates for surgical resection or platinum-based chemoradiation, or have metastatic NSCLC.
  3. As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should have received targeted therapies before tislelizumab.

Luis Paz-Ares, Head of the Medical Oncology Service at the Hospital Universitario 12 de Octubre, Madrid, emphasized the challenges in treating NSCLC and welcomed tislelizumab's approval, citing its demonstrated efficacy across several Phase 3 studies.

The EC approval is based on data from three Phase 3 studies within the RATIONALE program, involving 1,499 patients. These trials showcased tislelizumab's efficacy and manageable safety profile across different NSCLC populations.

BeiGene plans to market tislelizumab for NSCLC under the brand name TIZVENI®, while combining it with the ESCC indication under the brand name TEVIMBRA®, expected to launch in select EU countries later in 2024. TEVIMBRA is already approved in the U.S. and EU for advanced or metastatic ESCC and is currently under review for additional indications.

Tislelizumab, designed as a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody, has shown promise in enhancing the body's immune response against tumors while minimizing adverse effects.

This approval marks a significant advancement in addressing the urgent medical needs of NSCLC patients in Europe, offering a new therapeutic option with the potential to improve outcomes and quality of life.



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