Genentech says Tecentriq study met primary endpoint
Genentech, a member of the Roche Group, announced "positive" data from the Phase III IMpower110 study evaluating Tecentriq as a first-line monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in advanced non-squamous and squamous non-small cell lung cancer, or NSCLC, without ALK or EGFR mutations. The study met its primary endpoint in an interim analysis showing that Tecentriq monotherapy demonstrated a statistically significant overall survival benefit in people with high PD-L1 expression, compared with chemotherapy alone. 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 people with lower levels of PD-L1 expression. Genentech 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.