AstraZeneca has reported new Phase I extended follow-up data on its lung cancer drug Tagrisso, showing strong response rates in both the first- and second-line setting.
Phase I data from the AURA trial on Tagrisso (osimertinib), which investigated the drug as a first-line treatment in 60 patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer, showed tumour shrinkage in 77 percent.
Progression-free survival (PFS) was 19.3 months, with 55 percent of patients remaining progression-free at 18 months, according to the data, which were presented at the European Lung Cancer Conference.
Of the 60 first-line patients, five had tumours also harbouring the T790M mutation at diagnosis, and all five of these patients showed durable responses, the firm said.
“We are seeing consistently durable responses” in the study, noted Klaus Edvardsen, vice president of Clinical Oncology and interim head of Oncology, Global Medicines Development, at AZ, and added that “the ongoing Phase III FLAURA trial will further characterise the potential of osimertinib 80mg in the first-line EGFRm setting”.
An analysis of pooled data from the AURA Phase II studies also support the drug’s use in the second-line setting; 411 pre-treated patients with EGFR T790M mutation-positive NSCLC showed a median PFS of 11 months, an ORR of 66 percent, and a median duration of response of 12.5 months.
Tagrisso recently won accelerated approval as the first indicated treatment for patients with EGFR T790M mutation-positive metastatic NSCLC in the US, EU and Japan. The ongoing confirmatory Phase III trial, AURA3, is assessing the efficacy and safety of the drug versus platinum-based doublet chemotherapy in this patient group. AZ is also carrying out studies in the adjuvant and locally-advanced/metastatic first-line EGFRm settings, in patients with and without brain metastases, in leptomeningeal disease, and in combination with other compounds.