Roche secures two EC approvals for Tecentriq in lung cancer

Roche announced that the European Commission has approved and granted marketing authorisation for Tecentriq (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).

“This approval makes Tecentriq the first cancer immunotherapy available in Europe for the initial treatment of extensive-stage small cell lung cancer, marking an important step forward for patients,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “The combination of Tecentriq and chemotherapy has been shown to improve survival compared to the current standard-of-care – an advance that, until now, has been difficult to achieve due to the refractory nature of this disease.”

This approval is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared with chemotherapy alone (median overall survival [OS]=12.3 versus 10.3 months; hazard ratio [HR]=0.70, 95% CI: 0.54–0.91; p=0.0069) in the intention-to-treat (ITT) population. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival [PFS]) compared with chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77; 95% CI, 0.62–0.96; p=0.017). Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq.

Lung cancer is the leading cause of cancer death worldwide and SCLC accounts for approximately 15% of all lung cancer cases, with the majority of patients (70%) diagnosed in the “extensive stage”, often meaning a poor prognosis. SCLC is distinguished from other lung cancer subtypes due to its aggressive nature, rapid growth, and early development of metastatic disease.

Currently, Roche has nine Phase III lung cancer studies underway evaluating Tecentriq alone or in combination with other medicines across different types of lung cancer. Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.