BeiGene has announced that its Tizveni (tislelizumab) has received approval from the European Commission (EC) to treat non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use.
Currently the third most common cancer in Europe, lung cancer is the leading cause of cancer-related deaths globally, up to 90% of which are represented by NSCLC.
The new indications include Tizveni in combination with carboplatin and either paclitaxel or nab-paclitaxel for first-line treatment of adults with squamous NSCLC who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation, or metastatic NSCLC, as well as Tizveni as a monotherapy treatment for adults with locally advanced or metastatic NSCLC after platinum-based therapy, also including EGFR mutant or ALK-positive NSCLC, after prior targeted therapy.
As its third indication, Tizveni has been approved in combination with pemetrexed and platinum-containing chemotherapy for first-line treatment of adults with non-squamous NSCLC whose tumours have PD-L1 expression on at least 50% of tumour cells, with no EGFR or ALK positive mutations, and for locally advanced NSCLC patients who are not candidates for surgical resection, platinum-based chemoradiation, or metastatic NSCLC patients.
The EC’s approval was based on results from the three phase 3 studies in the RATIONALE programme, which involved 1,499 NSCLC patients. The RATIONALE 307, RATIONALE 304 and RATIONALE 303 all met their primary endpoints and demonstrated significant improvement in progression-free survival, overall survival, higher response rates and a manageable safety and tolerability profile.
Mark Lanasa, chief medical officer, solid tumours, BeiGene, commented: “[The] EC authorisation marks the second in the region for [Tizveni], with both NSCLC and locally advanced or metastatic oesophageal squamous cell carcinoma (ESCC) now approved in the EU.”
The company plans to combine the NSCLC indications with the second-line ESCC indication under the brand name Tevimbra, which will launch in EU countries later in 2024.
Already approved in the US and the EU for advanced or metastatic ESCC after prior chemotherapy, Tevimbra is currently under review by the European Medicines Agency and the US Food and Drug Administration as a first-line treatment for patients with unresectable or recurrent locally advanced or metastatic ESCC, as well as for first-line gastric or gastroesophageal junction cancers.