Swiss pharma firm Roche has announced that its cancer immunotherapy Tecentriq (atezolizumab) has demonstrated positive data in early-stage non-small cell lung cancer (NSCLC) in a pivotal Phase III study.

The Phase III IMpower010 study assessing Tecentriq (atezolizumab) against best supportive care (BSC) met its primary endpoint of disease-free survival (DFS) at the interim analysis. The drug was studied as adjuvant therapy after surgery and chemotherapy in patients with Stage II-IIIa NSCLC.

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Tecentriq is a monoclonal antibody that binds with a protein called programmed death ligand-1 (PD-L1), which manifests on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq is thought to enable the activation of T-cells.

Tecentriq showed a statistically significant improvement in DFS. The DFS benefit was found to be especially strong in the PD-L1-positive treatment population.

No new safety signals were identified. Further studies are planned to analyse DFS in the overall intent-to-treat population, which at the time of the trials, did not cross the threshold, and overall survival data, which were immature at the time of interim analysis, the company said.

“With these landmark results, Tecentriq has become the first cancer immunotherapy to help many people with resectable early lung cancer live longer without their cancer returning,” said Roche’s chief medical officer and head of global product development Dr Levi Garraway.

“We’re excited by the clinical benefit adjuvant Tecentriq may bring to lung cancer patients, particularly in the PD-L1-positive population. We will submit these data to regulatory authorities as soon as possible.”

Roche said full results from the Phase III IMpower010 study will be revealed at an undisclosed upcoming medical meeting and submitted to health authorities globally, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Tecentriq has proven itself to be a tried and tested combination treatment for numerous forms of lung cancer, a disease that kills 1.8 million people worldwide each year, and currently has five approved lung cancer indications in markets around the world.

The drug was the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small-cell lung cancer (SCLC) in combination with carboplatin and chemotherapy. Tecentriq also has four approved indications in NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies.

Roche has big plans for expanding the market presence of its blockbuster cancer drug, including multiple ongoing Phase III studies across various lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers.

Tecentriq has been able to generate a niche away from Merck’s market-dominant Keytruda (pembrolizumab), which has become the standard-of-care immunotherapy for treating newly-diagnosed NSCLC but failed to demonstrate the same advantage in the less common but often more aggressive SCLC.

Future studies evaluate Tecentriq alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various types of tumours.