BeiGene’s Tevimbra (tislelizumab-jsgr) has been approved by the US Food and Drug Administration (FDA) as part of a first-line combination treatment for advanced oesophageal squamous cell carcinoma (ESCC).
The drug has been specifically authorised for use alongside platinum-containing chemotherapy to treat unresectable or metastatic ESCC in adults whose tumours express PD-L1.
Oesophageal cancer is the sixth most common cause of cancer-related deaths worldwide, with ESCC accounting for nearly 90% of all cases.
BeiGene’s Tevimbra is a humanised immunoglobulin G4 anti-PD-1 monoclonal antibody that is designed to help the body’s immune cells detect and fight tumours.
The drug is already approved in the US as a monotherapy for adults with unresectable or metastatic ESCC after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor and in combination with chemotherapy for the first-line treatment of adults with gastric and gastroesophageal junction cancers.
The FDA’s latest decision was based on positive results from the late-stage RATIONALE-306 trial, which met its primary endpoint and demonstrated a statistically significant improvement in overall survival (OS) for adults randomised to Tevimbra plus chemotherapy compared to those receiving placebo in combination with chemotherapy.
Among PD-L1 positive patients, a median OS of 16.8 months was observed for those receiving the Tevimbra combination compared to 9.6 months for the placebo plus chemotherapy group, resulting in a 34% reduction in the risk of death.
Mark Lanasa, chief medical officer, solid tumours at BeiGene, said: “[The FDA’s] approval of Tevimbra for the first-line treatment of advanced ESCC marks a significant step forward in tackling the unmet needs in this challenging disease area.”
Sharing a similar sentiment, Nataliya Uboha, associate professor, University of Wisconsin, Carbone Cancer Center, said: “The approval of Tevimbra in combination with chemotherapy for adult patients with ESCC expands first-line treatment options for patients with this disease.
“There is a critical need for effective treatments of ESCC, and Tevimbra has been shown to improve outcomes in this patient population.”
The authorisation comes just two months after the FDA approved Tevimbra for its advanced gastric cancer indication.
The drug was authorised for use alongside platinum- and fluoropyrimidine-based chemotherapy to treat unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumours express PD-L1.