CHMP Recommends BeiGene’s Tevimbra for Gastric and Esophageal Cancer

BeiGene’s drug Tevimbra (tislelizumab) has received a recommendation from the European Medicines Agency’s human medicines committee for use as an initial treatment in patients with gastric and oesophageal cancers. Specifically, the Committee for Medicinal Products for Human Use (CHMP) has recommended the use of the PD-1 inhibitor in combination with chemotherapy treatments based on platinum and fluoropyrimidine for adults with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. It is also recommended for use in conjunction with platinum-based chemotherapy for adults with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (ESCC).

To be eligible for Tevimbra, patients must have tumours that express PD-L1 with a tumour area positivity (TAP) score of at least 5%. Gastric cancer ranks as the fifth leading cause of cancer-related deaths worldwide, while oesophageal cancer is the sixth. Currently, Tevimbra is already approved in the European Union for certain cases of advanced or metastatic ESCC after prior treatment with platinum-based chemotherapy. It is also approved for three indications in non-small cell lung cancer, covering both first- and second-line treatment settings.

The CHMP's decision to recommend Tevimbra for G/GEJ cancer was supported by positive outcomes from the late-stage RATIONALE-305 trial. In this study, BeiGene’s drug, combined with the investigator’s choice of chemotherapy, resulted in a 20% reduction in the risk of death compared to patients who received a placebo plus chemotherapy. The benefit of Tevimbra was even more pronounced in patients whose tumours expressed PD-L1 with a TAP score of at least 5%, showing a 29% reduction in the risk of death compared to the placebo group.

Additionally, the committee’s recommendation for the use of Tevimbra in ESCC was based on the results from the phase 3 RATIONALE-306 trial. This study demonstrated a 34% reduction in the risk of death for patients receiving Tevimbra in combination with chemotherapy, compared to those receiving a placebo with chemotherapy. For patients expressing PD-L1 with a TAP score of at least 5%, the three-year overall survival rate was also significantly better in the Tevimbra group, showing a 38% reduction in the risk of death.

Mark Lanasa, the chief medical officer for solid tumours at BeiGene, expressed optimism about the potential impact of these CHMP opinions. He noted that this recommendation brings the company closer to providing an innovative treatment option to patients with untreated G/GEJ cancer and ESCC, who currently face poor prognoses and limited treatment options.

Following the CHMP's recommendation, the European Commission will now deliberate on these recommendations to make a final decision regarding the approval of Tevimbra for these indications.