ASTRIS: A real world treatment study of osimertinib in patients (pts) with EGFR T790M positive non-small cell lung cancer (NSCLC).

9036 Background: Osimertinib is an oral, irreversible, central nervous system (CNS) active EGFR tyrosine kinase inhibitor (TKI) selective for both EGFR-TKI sensitizing and T790M resistance mutations. We report results from the first predefined interim analysis of the ongoing ASTRIS study (NCT02474355). Methods: Pts received osimertinib 80 mg once daily. Eligible pts had Stage IIIB-IV NSCLC harbouring a T790M mutation determined by local validated molecular test (not restricted by sample type), received prior EGFR-TKI therapy, WHO performance status (PS) 0−2, acceptable organ and bone marrow function and no history of interstitial lung disease (ILD) or QTc prolongation. Asymptomatic, stable CNS metastases were permitted. The primary efficacy outcome was overall survival; other outcomes included investigator-assessed response rate (RR), progression-free survival and time to treatment discontinuation. Safety data are also reported. Results: From study start (18 Sept 2015) to data cut-off (DCO; 3 Nov 2016), 1217 pts received osimertinib from 120 sites with a median follow-up of 4.1 mths ( < 1−14 mths), median age 64 yrs (27–92 yrs), 67% female, 61% White, 37% Asian, 87% WHO PS 0/1, 44% prior chemotherapy, 45% prior radiotherapy. All pts tested positive for T790M, identified from tissue in 682 pts (56%), plasma ctDNA in 433 pts (36%) and from other specimens in 102 pts (8%). At DCO, 317 pts (26%) had discontinued treatment, 900 pts (74%) were ongoing, median duration of exposure 3.8 mths ( < 1–13.2 mths), 168 pts (14%) had disease progression and 156 pts (13%) had died. In pts evaluable for response, the investigator-assessed RR was 64% (569/886; 95% CI 61, 67). Adverse events (AEs) leading to dose modification and treatment discontinuation were reported in 122 (10%) and 54 pts (4%), respectively. Serious AEs were reported in 165 pts (14%) and AEs leading to death in 30 pts (2%). ILD/pneumonitis-like events were reported in 25 pts (2%), and QTc prolongation in 9 pts (1%). Conclusions: ASTRIS, the largest reported clinical study of osimertinib in T790M-positive NSCLC, demonstrates clinical activity similar to that observed in the osimertinib clinical trial program with no new safety signals. Clinical trial information: NCT02474355.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.