European Commission approves Roche’s Tecentriq as adjuvant treatment for early-stage NSCLC

Roche today announced that the European Commission has approved Tecentriq (atezolizumab) as an adjuvant treatment, following complete resection and platinum-based chemotherapy, for adults with Non-Small Cell Lung Cancer (NSCLC) with a high risk of recurrence whose tumours express PD-L1≥50% and who do not have EGFR mutant or ALK-positive NSCLC.

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 per cent (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≥50%, who do not have EGFR mutant or ALK-positive NSCLC, compared with the best supportive care. A DFS benefit was consistently seen across most subgroups, including histology or stage of disease with adjuvant Tecentriq, compared with BSC. Overall survival 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), Roche said in a statement.

It also said that 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 were identified.

To date, Tecentriq has been approved in 19 countries, including the US and China, as adjuvant treatment, following complete resection and chemotherapy, for adults with stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours express PD-L1≥1%. In three countries, including Canada and the UK, Tecentriq has been approved as adjuvant, treatment following complete resection and chemotherapy, for adult patients with stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours have PD-L1 expression on ≥50% of tumour cells, the statement added.

Tecentriq has shown clinically meaningful benefit in various types of lung cancers, with six currently approved indications in countries around the world. It was the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage Small Cell Lung Cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced or metastatic NSCLC as either a single agent, or in combination with targetted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks, the statement also mentioned.

Roche 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, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumour types.