European Commission Approves Tislelizumab for Non-Small Cell Lung Cancer

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The approval, given across three indications, follows a previous approval for second-line use in esophageal squamous cell carcinoma.

BeiGene has announced that the European Commission has approved tislelizumab for the treatment of non-small lung cancer (NSCLC) across three indications.

The approved indications are:

  • Combined with carboplatin and either paclitaxel or nab-paclitaxel to treat adult patients with squamous, locally advanced NSCLC who are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC;
  • Combined with pemetrexed and platinum-containing chemotherapy as a first-line treatment for adults with non-squamous, locally advanced NSCLC with tumors that have PDL1 expression on over half of tumor cells without estimated glomerular filtration rate (EGFR) mutation or anaplastic lymphoma kinase (ALK) positive mutations and are not candidates for surgical resection or platinum based chemoradiation, or metastatic NSCLC;
  • Monotherapy for adult patients with locally advanced or metastatic NSCLC after previous platinum-based therapy.

“Tislelizumab is foundational for BeiGene’s solid tumor portfolio and has demonstrated its potential across multiple tumor types, including NSCLC, in which there remains a significant unmet need at all stages of the disease,” said Mark Lanasa, PhD, chief medical officer, Solid Tumors at BeiGene(1).. “Today’s EC authorization marks the second in the region for tislelizumab, with both NSCLC and locally advanced or metastatic esophageal squamous cell carcinoma now approved in the European Union.”

The EC granted this approval to tislelizumab under the brand name Tizveni. BeiGene plans to combine these indications with the second-line ESCC indication under the brand name Tevimbra, which it will launch in the EU later in 2024.

The approval was supported by data from 3 registrational trials that included nearly 1500 patients (1). The RATIONALE 307 trial (NCT03594747), which enrolled 360 patients with advanced squamous NSCLC, met its primary endpoint of statistically significant improvement in progression free survival (PFS), as well as higher objective response rates and a manageable safety profile following first-line tislelizumab in combination with chemotherapy regardless of PD-L1 expression. The RATIONALE 304 trial (NCT03663205), which enrolled 334 patients with locally advanced or metastatic non-squamous NSCLC, met its primary endpoint of statistically significant improvement in PFS compared to chemotherapy, as well as demonstrating higher response rates and longer response duration, following first-line tislelizumab in combination with chemotherapy.

Lastly, the RATIONALE 303 trial (NCT03358875), which enrolled 805 patients with advanced NSCLC who progressed on prior platinum-based chemotherapy, met its primary endpoint, with second- or third-line tislelizumab resulting in statistically significant and clinically meaningful improvement in overall survival compared with docetaxel in the intent-to-treat population regardless of PD-L1 expression.

Tislelizumab is currently under review by the European Medicines Agency and the FDA as a first-line treatment for patients with unresectable, recurrent, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) and for first-line gastric or gastroesophageal junction cancers. Just last month, BeiGene received FDA approval for tislelizumab (Tevimbra) as a second-line monotherapy for the treatment of adult patients with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor (2).

BeiGene has thus far reported positive data readouts for tislelizumab—a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1—from more than a dozen Phase 3 and Phase 2 clinical trials demonstrating clinically meaningful improvements in survival and quality of life for patients across a range of tumor types.


  1. BeiGene, BeiGene Receives European Commission Approval for Tislelizumab as Treatment for Non-Small Cell Lung Cancer. Apr. 23, 2024.
  2. BeiGene. BeiGene Receives FDA Approval for Tevimbra for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy. March 14, 2024.