Roche's Tecentriq Becomes First Immune Therapy Approved in the EU for Adjuvant Treatment of Early-Stage NSCLC

ByLeaves

On June 9, Roche announced that the European Commission has approved atezolizumab (Tecentriq) as an adjuvant treatment for adult patients with high recurrence risk of stage II-III non-small cell lung cancer (NSCLC) after complete resection and platinum-based chemotherapy. The tumors express PD-L1≥50% and have no EGFR mutations or are not ALK-positive NSCLC.

This approval is based on the interim analysis results of the Phase III IMpower010 study. The results showed that, compared with Best Supportive Care (BSC), treatment with Tecentriq after 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). The DFS benefit compared to BSC was consistently observed across most subgroups (including histology or disease stage for adjuvant Tecentriq). Overall Survival (OS) data are not yet mature, but trends indicate that the use of Tecentriq may improve OS.

This is the sixth lung cancer indication for Tecentriq approved in Europe, and the first and only cancer adjuvant immunotherapy available for patients with Stage II-III NSCLC in Europe. To date, Tecentriq has been approved in 19 countries, including the United States and China, as an adjuvant treatment for adult patients with Stage II-IIIA NSCLC whose tumors express PD-L1≥1% following complete resection and chemotherapy. In three countries, including Canada and the United Kingdom, Tecentriq has also been approved as an adjuvant treatment for adult patients with Stage II-IIIA NSCLC whose tumor cells express PD-L1≥50% following complete resection and chemotherapy.

This is another groundbreaking therapy approved in Europe for Roche, following the prior approval of Lunsumio (mosunetuzumab), the world's first CD20/CD3-specific bispecific antibody, in the European Union.

IMpower010 is a global Phase III, multicenter, open-label randomized study designed to evaluate the efficacy and safety of Tecentriq compared to BSC in participants with Stage IB-IIIA non-small cell lung cancer following surgical resection and up to four cycles of adjuvant chemotherapy based on cisplatin. The study randomly assigned 1005 participants in a 1:1 ratio to receive either Tecentriq (for up to 16 cycles) or BSC treatment. The primary endpoint was investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all-randomized Stage II-IIIA, and intention-to-treat (ITT) Stage IB-IIIA populations, with key secondary endpoints including overall survival in the ITT population.

Tecentriq has demonstrated clinically meaningful benefits across various types of lung cancer and is now approved for six indications in countries worldwide. Tecentriq is the first approved immunotherapy for the first-line treatment of adult patients with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications for advanced or metastatic non-small cell lung cancer, where it can be used as a single agent or in combination with targeted therapies and/or chemotherapy. Tecentriq offers three dosing options, providing flexible administration every two, three, or four weeks.

Roche has established an extensive development plan for Tecentriq, including multiple ongoing and planned Phase III studies across lung cancer, genitourinary cancer, skin cancer, breast cancer, gastrointestinal cancer, gynecological cancer, and head and neck cancer. This includes studies evaluating Tecentriq both as a monotherapy and in combination with other drugs, as well as metastatic, adjuvant, and neoadjuvant studies across various tumor types.