AstraZeneca presents positive Phase III results for lung cancer drug Tagrisso
pharmafile | July 18, 2016 | News story | Manufacturing and Production, Research and Development | AstraZeneca, Tagrisso
AstraZeneca has presented results from the latest Phase III trial evaluating Tagrisso (osimertinib) as a second line treatment for patients with a specific kind of non-small cell lung cancer (NSCLC) which demonstrated superior progression-free survival compared to standard platinum-based doublet chemotherapy.
In the AURA3 trial, more than 400 patients with EGFR T790m mutation positive, locally-advanced or metastatic NSCLS, whose disease had progressed following first line EGFR tyrosine kinase inhibitor therapy, received Tagrisso.
The drug was made available early to patients in the UK via the Early Access to Medicines Scheme, before receiving a full approval from the European Commission. It was, however, rejected by a preliminary NICE committee as not meeting the criteria to be considered for inclusion in the revamped Cancer Drugs Fund. It has been approved in the EU, US and Japan, among others, as the first treatment for patients with EGFR T790M mutation-positive advanced NSCLC.
In addition to meeting the primary endpoint of superior progression-free survival, the objective response rate, disease control rate and duration of response also achieved clinically meaningful levels in the late-stage trial.
Sean Bohen, chief medical officer at AstraZeneca, says: “These results confirm Tagrisso as a meaningful alternative to benefit EGFR T790M lung cancer patients. The AURA3 results demonstrate the benefits of our science-led approach that enabled the rapid development of Tagrisso as a targeted treatment to address the most common cause of resistance to a first-generation EGFR-TKI for patients with metastatic EGFR-mutant lung cancer.”
AstraZeneca will continue to explore what it calls the “full potential” of Tagrisso as both a monotherapy and in combination for other lung cancer indications. It is also testing Tagrisso in NSCLC patients with or without brain metastases, and has also presented initial encouraging data in a small cohort of patients with leptomeningeal disease, a rare but terminal complication associated with cancer.
Sean Murray
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