Roche Group’s Genentech has reported positive results from its Phase III OAK study of TECENTRIQ to treat locally advanced or metastatic non-small-cell lung cancer (NSCLC).
TECENTRIQ is a monoclonal antibody that binds with a protein called PD-L1.
PD-L1 is expressed on tumour cells and tumour-infiltrating immune cells, which after being targeted by TECENTRIQ is prevented from interacting with both PD-1 and B7.1 receptors.
The inhibition of PD-L1 is believed to activate T-cells.
The global, multicentre, open-label, randomised, controlled Phase III OAK study was designed to test the safety and efficacy of TECENTRIQ when compared with docetaxel, to treat locally advanced or metastatic NSCLC whose disease progressed on or after treatment with platinum-containing chemotherapy.
It involved 1,225 patients who were randomised on the basis of 1:1 to be administered with either docetaxel or TECENTRIQ every three weeks.
The study’s co-primary endpoints were to achieve an overall survival of all the patients enrolled in the study, which was assessed on the first 850 randomised patients.
The secondary endpoint was to achieve the objective response rate (ORR), progression-free survival (PFS) and duration of response (DOR) including safety in the administration of TECENTRIQ, which was assessed on the basis of all 1,225 randomised patients.
Results suggested that TECENTRIQ lead to a clinically significant improvement in overall survival (OS) in people suffering from the disease.
Genetech global product development head and chief medical officer Sandra Horning said: “These results add to the growing body of evidence that supports the role of TECENTRIQ as a potential new treatment for specific types of advanced NSCLC.
“This is very encouraging news for people living with this disease because lung cancer is the leading cause of cancer deaths around the world. We hope to bring this treatment option to patients as soon as possible.”
The company is currently undertaking eight Phase III lung studies to test TECENTRIQ alone or in combination with other treatments in people with early and advanced stages of lung cancer.