BeiGene’s tislelizumab has been recommended by the European Medicines Agency’s human medicine committee for approval as a treatment for non-small cell lung cancer (NSCLC) across three indications.
The Committee for Medicinal Products for Human Use’s (CHMP) recommendation was based on the results of three phase 3 clinical trials evaluating tislelizumab as a first- and second-line NSCLC treatment.
Lung cancer is the second most common type of cancer and the leading cause of cancer-related death globally, with NSCLC representing 85 to 90% of all cases of the disease.
The committee recommends tislelizumab for adult patients with squamous NSCLC who are not eligible for surgical resection, platinum-based chemoradiation or metastatic NSCLC, in combination with carboplatin and either paclitaxel or nab-paclitaxel as a first-line treatment.
The second indication recommends tislelizumab in combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of adult patients with no squamous NSCLC whose tumours have PD-L1 expression on over 50% of tumours with no EGFR or ALK positive mutations, and who have locally advanced NSCLC who are not candidates for surgical resection, platinum-based chemoradiation or metastatic NSCLC.
Lastly, tislelizumab is recommended as a monotherapy to treat adult patients with locally advanced or metastatic NSCLC following prior platinum-based therapy. In addition, patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies prior to tislelizumab.
The CHMP’s recommendation was based on the results of three phase 3 clinical trials, which enrolled nearly 1,500 patients worldwide.
First-line combination therapy results evaluating tislelizumab in advanced squamous NSCLC were reported in RATIONALE 307 and RATIONALE 304, which were published in JAMA Oncology and the Journal of Thoracic Oncology.
Additionally, second-line monotherapy results evaluating tislelizumab in previously treated advanced NSCLC patients in the RATIONALE 303 trial were published in the Journal of Thoracic Oncology.
Mark Lanasa, BeiGene’s chief medical officer, solid tumours, said: “[The] positive CHMP opinion brings us one step closer to providing an important treatment option to patients in Europe with lung cancer.”
Tislelizumab, under the brand name Tevimbra, has already received approval from the European Commission for advanced or metastatic oesophageal squamous cell carcinoma and is currently under review with the US Food and Drug Administration.