James Chih-Hsin Yang, MD, discusses the final safety and efficacy results from 2 phase I expansion cohorts from the phase I/II AURA trial.
James Chih-Hsin Yang, MD, director, Graduate Institute of Oncology, director, Department of Oncology at National Taiwan University Hospital, discusses the final safety and efficacy results from 2 phase I expansion cohorts from the phase I/II AURA trial (NCT01802632). Both cohorts received osimertinib (Tagrisso) at a dose of either 80 mg or 160 mg for advanced EGFR mutation-positive advanced non—small cell lung cancer (NSCLC).
For the trial, investigators sought to determine the durability of response for these patients. Results showed that the response rate has been high for both groups, at 67% and 87% for the 80-mg cohort and the 160-mg cohort, respectively. The median duration of response is approximately 20 months, which Yang explained is consistent with findings from the phase III FLAURA trial (NCT02296125).
At the time of data cutoff, May 1, 2018, 11 patients were still receiving the study drug. At 3 years, 25% of patients were still receiving treatment, and at 4 years, 18% of patients had durable response. In terms of progression-free survival, at a cutoff of 3 months, 20% of patients were progression-free. At 4 years, 14% of patients are still progression-free, as estimated by Kaplan—Meier curves. These results, Yang explains, provide confidence that osimertinib may induce durable response in at least some of these patients in the first line.