BeiGene has announced that its Tevimbra (tislelizumab) has been approved by the European Commission (EC) as part of a first-line combination treatment for an aggressive form of lung cancer.
The drug has been specifically authorised in combination with etoposide and platinum chemotherapy to treat adult patients with extensive-stage small cell lung cancer (SCLC).
SCLC grows and spreads at a much faster rate than other types of lung cancer, and accounts for approximately 15% of all cases of the disease. Around 70% of SCLC patients are diagnosed with extensive-stage disease, which is associated with a particularly poor prognosis.
The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and was based on data from the late-stage RATIONALE-312 trial, in which the Tevimbra combination was associated with a statistically significant and clinically meaningful improvement in overall survival (OS) compared to placebo plus chemotherapy in the intent-to-treat population.
Median OS was 15.5 months for Tevimbra plus chemotherapy compared to 13.5 months for placebo plus chemotherapy, resulting in a 25% reduction in the risk of death.
Also supporting the approval was pooled safety data from over 3,900 patients who received Tevimbra as either a single agent or in combination with chemotherapy at the approved dosing regimen.
“The results of the RATIONALE-312 study demonstrated that [Tevimbra] plus chemotherapy improved survival compared to treatment with placebo plus chemotherapy, highlighting its potential to deliver better outcomes for eligible patients,” said Silvia Novello, president Women Against Lung Cancer in Europe and head of medical oncology Unit of San Luigi Hospital.
Administered as an intravenous infusion, 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 EU to treat certain cases of non-small lung cancer, as well as oesophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma.
Mark Lanasa, chief medical officer, solid tumours at BeiGene, said: “Tevimbra has now been approved in four distinct disease areas in the EU in under two years, underscoring its ability to demonstrate clinically meaningful improvements in survival and a well-characterised safety profile across a range of tumour types.”