EC approves Roche’s Tecentriq for early-stage lung cancer

Roche’s Tecentriq (atezolizumab) has been approved by the European Commission (EC) for adults with non-small cell lung cancer (NSCLC) who have a high risk of the disease reoccurring.

The EC’s decision is based on data from the phase 3 IMpower010 study. The results showed Tecentriq, when used as an adjuvant therapy, reduced the risk of disease recurrence or death by 57% in people with PD-L1 high resected stage 2-3 NSCLC, compared with best supportive care.

The safety data taken from the study were consistent with Tecentriq’s known safety profile, while no new safety signals were found.

A follow-up is scheduled to take place with a planned analysis of more mature overall survival data later in 2022.

“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, 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.”

Tecentriq has been approved in 19 countries as an adjuvant therapy to date, including the US and China, for adults with stage 2-3A NSCLC.

Tecentriq was the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with chemotherapy. The immunotherapy has shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications in countries around the world.

“Today’s approval now offers patients in Europe, whose tumours express high levels of PD-L1, the opportunity to reduce their risk of disease recurrence following surgery and chemotherapy,” said Professor Enriqueta Felip, Head of the Thoracic Cancer Unit at Vall d’Hebron Institute of Oncology, Barcelona, Spain.

“This milestone reinforces the need for biomarker testing at diagnosis for all people with NSCLC, irrespective of disease stage, to ensure they receive optimal treatment.”