Osimertinib, phase III ADAURA trial will be unblinded early after overwhelming efficacy in the adjuvant treatment of patients with EGFR-mutated lung cancer
The ADAURA phase III trial for Tagrisso ( Osimertinib ) in the adjuvant treatment of patients with stage IB, II and IIIA epidermal growth factor receptor-mutated ( EGFRm ) non-small cell lung cancer ( NSCLC ) with complete tumour resection will be unblinded early following a recommendation from an IDMC ( Independent Data Monitoring Committee ) based on its determination of overwhelming efficacy.
The primary endpoint of the ADAURA trial is disease-free survival ( DFS ). Osimertinib was assessed against placebo for a treatment duration of up to three years.
The trial will continue to assess the secondary endpoint of overall survival.
The IDMC did not raise any new safety concerns.
ADAURA is a randomised, double-blinded, global, placebo-controlled trial in the adjuvant treatment of 682 patients with stage IB, II, IIIA EGFRm NSCLC with complete tumour resection and optional, standard post-operative adjuvant chemotherapy.
In the experimental arm, patients were treated with Osimertinib 80mg once-daily oral tablets for three years or until disease recurrence.
The trial enrolled in more than 200 centres across more than 20 countries, including the US, in Europe, South America, Asia and the Middle East.
Osimertinib is a third-generation, irreversible EGFR-TKI designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against CNS metastases.
Tagrisso 40mg and 80mg once-daily oral tablets have received approval in 80 countries, including the US, Japan, China and the EU, for 1st-line EGFRm advanced NSCLC, and in 87 countries, including the US, Japan, China and the EU, for 2nd-line use in patients with EGFR T790M mutation-positive advanced NSCLC.
Tagrisso is also being developed in the locally advanced unresectable setting ( LAURA ), in combination with chemotherapy ( FLAURA2 ) in the metastatic setting, and with potential new medicines to address resistance to EGFR-TKIs ( SAVANNAH, ORCHARD ).
Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths, more than breast, prostate and colorectal cancers combined.
Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.
Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.
These patients are particularly sensitive to treatment with EGFR-tyrosine kinase inhibitors ( TKIs ) which block the cell-signalling pathways that drive the growth of tumour cells. ( Xagena )
Source: AstraZeneca, 2020