The trial is evaluating Tecentriq as a first-line (initial) monotherapy compared against cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without ALK or EGFR mutations (Wild-Type or WT).
Roche’s phase III trial has achieved its primary endpoint in an interim analysis demonstrating that Tecentriq monotherapy showing a statistically significant OS benefit in people with high PD-L1 expression (TC3/IC3-WT) compared against chemotherapy alone.
Roche will share the positive data with global health authorities such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) to quickly provide the new drug option to patients.
Tecentriq is a monoclonal antibody developed to bind with PD-L1 protein that is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. Tecentriq will enable the activation of T cells by inhibiting PD-L1.
Roche global product development head and chief medical officer Dr Sandra Horning said: “We are encouraged that Tecentriq monotherapy has shown a significant survival benefit over chemotherapy as an initial treatment in people with squamous or non-squamous non-small cell lung cancer with high PD-L1 expression.”
Separately, Roche announced that satralizumab has significantly reduced relapse risk in second positive phase III study for neuromyelitis optica spectrum disorder (NMOSD), a rare, debilitating central nervous system disease.
The SAkuraStar study demonstrated that satralizumab monotherapy achieved a 55% reduction in the risk of relapses compared to placebo in the overall population.
Satralizumab is an investigational humanised monoclonal antibody designed to target the cytokine IL-6 receptor, a crucial driver in NMOSD.
Recently, Roche’s one-dose Xofluza (baloxavir marboxil) has achieved primary endpoint in phase III MINISTONE-2 study of children with flu.
The phase III trial has demonstrated that Xofluza was a well-tolerated and efficient potential treatment for flu in otherwise healthy children aged one to less than 12 years old.