European Commission approves Tecentriq as adjuvant treatment for a subset of people with early-stage non-small cell lung cancer.

“Today’s approval represents an important advance, as Tecentriq becomes the first cancer immunotherapy approved in Europe for the treatment of certain types of early-stage NSCLC,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Since approximately half of all people with early NSCLC develop recurrence after surgery, which in some cases is no longer curable, treating this cancer at an earlier stage offers the best chance to prevent recurrence.”

This approval is based on results from an interim analysis of the Phase III IMpower010 study. The results showed treatment with Tecentriq, following complete resection and platinum-based chemotherapy, reduced the risk of disease recurrence or death (DFS) by 57% (hazard ratio [HR]=0.43, 95% CI: 0.26-0.71) in people with resected Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours express PD-L1 greater than 50%, who do not have EGFR mutant or ALK-positive NSCLC, compared with best supportive care (BSC).

A DFS benefit was consistently seen across most subgroups including histology or stage of disease with adjuvant Tecentriq, compared with BSC. Overall survival (OS) data for patients with PD-L1 high resected Stage II-III NSCLC, and who do not have EGFR mutant or ALK-positive disease are immature and were not formally tested at the DFS interim analysis, however, a trend towards OS improvement with Tecentriq was seen, with a stratified HR of 0.39 (95% CI: 0.18-0.82). Follow-up will continue with planned analyses of more mature OS data later this year. Safety data for Tecentriq were consistent with its known safety profile and no new safety signals.