BeiGene’s Tevimbra (tislelizumab) has been recommended by the European Medicines Agency’s human medicines committee as a first-line treatment for gastric and oesophageal cancer patients.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the PD-1 inhibitor be used in combination with platinum- and fluoropyrimidine-based chemotherapy to treat adults with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, and in combination with platinum-based chemotherapy to treat adults with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (ESCC).
Those eligible for the drug will also have tumours that express PD-L1 with a tumour area positivity (TAP) score of at least 5%, according to the recommendations.
Gastric cancer is the fifth leading cause of cancer-related deaths globally, while oesophageal cancer is the sixth.
Tevimbra 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.
The CHMP’s decision for Tevimbra in G/GEJ cancer was based on positive results from the late-stage RATIONALE-305 trial, in which BeiGene’s drug 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 patients 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.
The committee’s recommendation in ESCC was supported by results from the phase 3 RATIONALE-306, which showed a 34% reduction in the risk of death for Tevimbra in combination chemotherapy 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, demonstrating a 38% reduction in the risk of death.
Mark Lanasa, chief medical officer, solid tumours at BeiGene, said: “With these CHMP opinions, we are one step closer to bringing this innovative therapy to eligible patients with untreated G/GEJ cancer and ESCC, who face a poor prognosis and limited treatment options.”
The European Commission will now consider the CHMP’s recommendations as it makes a final decision on Tevimbra in these indications.