The monoclonal antibody tislelizumab has been approved by the European Commission (EC) for use in patients with treatment-naive and relapsed non-small cell lung cancer (NSCLC), its manufacturer BeiGene has announced.
This follows its positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in March 2024.
The approval of tislelizumab (under the brand name Tizveni, but also known as Tevimbra) is across three indications, including first- and second-line use, which are:
- In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of adult patients with squamous NSCLC who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC
- In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of adult patients with non-squamous NSCLC whose tumours have PD-L1 expression on ≥50% of tumour cells with no EGFR or ALK positive mutations and who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC
- 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 also have received targeted therapies before receiving tislelizumab.
Tislelizumab, which is a PD-1 inhibitor, is also approved in the European Union for the treatment of locally advanced or metastatic oesophageal squamous cell carcinoma (OSCC) after prior chemotherapy.
The NSCLC indications were approved under the brand name Tizveni. However, BeiGene plans to combine the NSCLC indications with the second-line OSCC indication under the brand name Tevimbra, which will launch in the first EU countries later in 2024.
Commenting on the approval, Dr Luis Paz-Ares, head of the medical oncology service at University Hospital October 12 in Madrid, Spain, said: ‘Non-small cell lung cancer remains one of the most common and deadly cancers in Europe, with 50% of patients diagnosed already progressed to advanced stages, making it difficult to treat.
‘Across three phase 3 studies, tislelizumab has been shown to improve outcomes for patients with certain types of NSCLC, providing a new option for those facing the disease.’
The positive opinion for these indications is based on the results of three Phase 3 trials which demonstrated the benefit of tislelizumab as a first- and second-line treatment for patients with NSCLC: RATIONALE 307 and RATIONALE 304, which both looked at first-line treatment in combination with chemotherapy for various types of NSCLC, and RATIONALE 303, which looked at tislelizumab as second- and third-line treatment compared with docetaxel.
