BeiGene’s Tevimbra (tislelizumab) has been recommended by the European Medicines Agency’s human medicines committee as part of a first-line combination treatment for an aggressive form of lung cancer.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug be approved in combination with etoposide and platinum chemotherapy to treat adults with extensive-stage small cell lung cancer (SCLC).
Lung cancer is the leading cause of cancer-related deaths globally and SCLC, which grows and spreads more quickly than other types of the disease, accounts for around 15% of all cases.
Approximately 70% of SCLC patients are diagnosed with extensive-stage disease, classed as SCLC that has spread throughout or beyond the lungs, or exceeded an area that can be treated with radiation therapy alone.
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 EU to treat certain cases of oesophageal squamous cell carcinoma (ESCC), gastric or gastroesophageal junction (G/GEJ) adenocarcinoma and non-small lung cancer.
The CHMP’s latest decision was based on positive results from the phase 3 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 adults with extensive-stage SCLC.
Median OS was 15.5 months for Tevimbra plus chemotherapy compared to 13.5 months for placebo plus chemotherapy, representing a 25% reduction in the risk of death, and BeiGene’s combination was found to be generally well tolerated with no new safety signals identified.
Mark Lanasa, chief medical officer, solid tumours at BeiGene, said: “[This] positive CHMP opinion marks another important step for Tevimbra to potentially expand its indications in a fourth disease area in Europe to reach more patients affected by cancer.”
The European Commission (EC) will now review the CHMP’s recommendation as it makes a final decision on Tevimbra in extensive-stage SCLC.
The positive opinion comes four months after the EC approved Tevimbra for use alongside platinum- and fluoropyrimidine-based chemotherapy to treat patients with HER2-negative locally advanced unresectable or metastatic G/GEJ adenocarcinoma, and in combination with platinum-based chemotherapy for those with unresectable, locally advanced or metastatic ESCC.