The US Food and Drug Administration has approved Roche's Tecentriq (atezolizumab) as a first-line treatment for adults with metastatic non-small cell lung cancer (NSCLC) whose tumours have high PD-L1 expression, with no EGFR or ALK genomic tumour aberrations.
This decision rides on an interim analysis of data from the Phase III IMpower110 study, which showed that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy (median OS=20.2 versus 13.1 months) in people with high PD-L1 expression.
Also, safety for Tecentriq appeared to be consistent with its known safety profile, with no new concerns thrown up by the trial. Grade 3-4 treatment-related adverse events (AEs) were reported in 12.9% of people receiving Tecentriq compared with 44.1% of people receiving chemotherapy.
Tecentriq is the first and only single-agent cancer immunotherapy with three dosing options, allowing administration every two, three or four weeks.
In the US, the drug has received four approvals across NSCLC, including as a single agent or in combination with targeted therapies and/or chemotherapies. It is also approved in combination with carboplatin and etoposide (chemotherapy) for the first-line treatment of adults with extensive-stage small cell lung cancer.
“We are pleased to offer people with certain types of lung cancer a new chemotherapy-free option that can help prolong their lives and be administered on a flexible dosing schedule, including an option for once-a-month Tecentriq infusions,” said Levi Garraway, chief medical officer and head of Global Product Development.