Roche’s study met a goal, as a lung cancer monotherapy Tecentriq 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.
The study met its primary endpoint in an interim analysis showing that Tecentriq monotherapy demonstrated a statistically significant overall survival (OS) benefit in people with high PD-L1 expression (TC3/IC3-WT), compared with chemotherapy alone, Roche said Thursday in a press release. Furthermore, it said that safety for Tecentriq appeared to be consistent with its known safety profile and no new safety signals were identified. The study will continue to final analysis for patients with lower levels of PD-L1 expression.
Sandra Horning, Roche’s Chief Medical Officer is encouraged that these findings reinforce the potential of Tecentriq to play an important role in the treatment of multiple forms of lung cancer.
Roche said will now submit these data to global health authorities, including the FDA and EMA, and will discuss how best to bring this option to patients as quickly as possible. These data will be presented at an upcoming medical congress.
Currently, Roche said it has nine Phase III lung cancer studies underway evaluating Tecentriq as a monotherapy or in combination with other medicines across different types of lung cancer. Roche reminded it has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.
In a separate announcement, Genentech, a member of the Roche Group, presented Thursday full pivotal Phase III study results for satralizumab as a monotherapy for neuromyelitis optica spectrum disorder (NMOSD).
The study showed 55% reduction in the risk of relapse for satralizumab monotherapy versus placebo, and 74% reduction in the risk of relapse for satralizumab monotherapy versus placebo in people with neuromyelitis optica spectrum disorder (NMOSD) with aquaporin-4 antibodies (AQP4-IgG seropositive patients).