The European Medicines Agency’s human medicines committee has recommended that BeOne Medicines’ Tevimbra (tislelizumab) be approved for a new non-small cell lung cancer (NSCLC) indication.
The company formerly known as BeiGene announced that the drug has been recommended for use in combination with platinum-containing chemotherapy as a neoadjuvant treatment and then continued as monotherapy as an adjuvant treatment in adults with resectable NSCLC at high risk of recurrence.
The Committee for Medicinal Products for Human Use (CHMP)’s decision was supported by results from the late-stage RATIONALE-315 study, in which 56.2% of NSCLC patients treated with Tevimbra in combination with chemotherapy before surgery achieved major pathologic response, compared to 15% of patients randomised to receive chemotherapy in combination with placebo.
Pathological complete response was achieved by 40.7% of patients on the Tevimbra-based regimen versus 5.7% of those in the chemotherapy plus placebo cohort. BeOne’s drug also showed benefits in event-free survival and overall survival, and updated data on these endpoints will be submitted for presentation at an upcoming medical conference.
Lung cancer is the third most common cancer in Europe, with 484,306 people diagnosed in 2022 alone. NSCLC accounts for up to 90% of all lung cancer cases, and as many as 30% of patients with this form of the disease have resectable NSCLC at diagnosis.
Given as an intravenous infusion, BeOne’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 EU for a range of NSCLC indications, as well as certain cases of small cell lung cancer, oesophageal squamous cell carcinoma, gastric or gastroesophageal junction adenocarcinoma and nasopharyngeal carcinoma.
Mark Lanasa, chief medical officer, solid tumours at BeOne, said: “Tevimbra is already approved in the EU across multiple settings in NSCLC, the most common form of lung cancer, and this positive CHMP opinion expands its potential to help patients earlier in their treatment journey.”
The European Commission will now review the CHMP’s recommendation as it makes a decision on Tevimbra in this indication.