BeiGene’s
BeiGene’s Tevimbra approved by EC for first-line gastric and oesophageal cancer use
BeiGene’s Tevimbra (tislelizumab) has been approved by the European Commission (EC) as part of a first-line combination treatment for adults with advanced gastric or oesophageal cancer.
The drug has been authorised for use alongside platinum- and fluoropyrimidine-based chemotherapy to treat patients with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, and in combination with platinum-based chemotherapy for those with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (ESCC).
The approvals come just one month after the European Medicines Agency’s human medicines committee recommended Tevimbra for these indications.
The authorisation in G/GEJ cancer was based on positive results from the late-stage RATIONALE-305 trial, in which Tevimbra in combination with investigator’s choice of chemotherapy resulted in a 20% reduction in the risk of death compared to placebo plus chemotherapy in patients with advanced unresectable or metastatic G/GEJ cancer.
This benefit rose for those expressing PD-L1 with a TAP score of at least 5%, with Tevimbra-chemotherapy demonstrating a 29% reduction in the risk of death compared to the placebo arm in this population.
Data from the phase 3 RATIONALE-306 study supported the approval in ESCC, with Tevimbra plus chemotherapy associated with a 34% reduction in the risk of death versus placebo plus chemotherapy for patients unresectable, locally advanced recurrent or metastatic ESCC.
Three-year overall survival in patients expressing PD-L1 with a TAP score of at least 5% was also substantially improved in favour of the Tevimbra arm, showing a 38% reduction in the risk of death.
Gastric cancer is the fifth leading cause of cancer-related deaths globally and oesophageal cancer is the sixth.
BeiGene’s Tevimbra is a PD-1 inhibitor that is designed to help the body’s immune cells detect and fight tumours. The drug is already approved in the EU for certain cases of advanced or metastatic ESCC after prior platinum-based chemotherapy, and for three non-small cell lung cancer indications covering both the first- and second-line settings.
