IMpower010: Atezolizumab improves disease-free survival in people with resectable early stage lung cancer compared to best supportive care
The phase III IMpower010 study evaluating Atezolizumab ( Tecentriq ), compared with best supportive care ( BSC ), has met its primary endpoint of disease-free survival ( DFS ) at the interim analysis.
Atezolizumab has shown a statistically significant improvement in disease-free survival as adjuvant therapy following surgery and chemotherapy in all randomised stage II-IIIA populations with non-small cell lung cancer ( NSCLC ).
The magnitude of DFS benefit was particularly pronounced in the PD-L1-positive population.
Follow-up will continue with planned analyses of disease-free survival in the overall intent-to-treat ( ITT ) population, which at the time of analysis did not cross the threshold, and overall survival ( OS ) data, which were immature at the time of interim analysis.
Safety for Atezolizumab was consistent with its known safety profile and no new safety signals were identified.
IMpower010 is a phase III, global, multicentre, open-label, randomised study evaluating the efficacy and safety of Atezolizumab compared with BSC, in participants with stage IB-IIIA NSCLC ( UICC 7th edition ), following surgical resection and up to 4 cycles of adjuvant Cisplatin-based chemotherapy.
The study randomised 1,005 people with a ratio of 1:1 to receive either at most 16 cycles of Atezolizumab or BSC.
The primary endpoint is investigator-determined disease-free survival in the PD-L1-positive stage II-IIIA, all randomised stage II-IIIA and ITT stage IB-IIIA populations.
Key secondary endpoints include overall survival in the overall study population, ITT stage IB-IIIA NSCLC.
Atezolizumab is a monoclonal antibody designed to bind with PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Atezolizumab may enable the activation of T-cells.
Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small-cell lung cancer, small-cell lung cancer ( SCLC ), certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma.
In the US, Tecentriq is also approved in combination with Cotellic ( Cobimetinib ) and Zelboraf ( Vemurafenib ) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.
Lung cancer is the one of the leading causes of cancer death globally. Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.
Lung cancer can be broadly divided into two major types: non-small-cell lung cancer and small cell lung cancer.
Non-small-cell lung cancer is the most prevalent type, accounting for around 85% of all cases.
NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope. ( Xagena )
Source: Roche, 2021