Late Breaking Abstract - Phase 2, multi-center, open label, single-arm study of TAS-115, a novel multi-kinase inhibitor in patients with idiopathic pulmonary fibrosis

Background: TAS-115 is a multi-kinase inhibitor. In addition to the blockade of PDGFR and VEGFR, TAS-115 inhibits M-CSF, which has been reported to be a key chemoattractant for fibrocytes. Several studies suggest that TAS-115 may exert beneficial effects on pulmonary fibrosis by targeting the M-CSF as well as PDGFR. Methods: This study evaluated the efficacy and safety of TAS-115 in idiopathic pulmonary fibrosis (IPF) patients (pts) including decrease of % FVC after or unfit for standard therapy. TAS-115 was administered 200 mg once daily, repeated for 13 weeks or up to 26 weeks in pts with clinical response. The primary objective was to compare the intra-patient change of % FVC before and after initiation of TAS-115. Results: As of 17 May 2019, 41 pts received TAS-115. 21 out of 25 pts (84%) reached at week 13 showed positive change from estimated decline % FVC based on the data prior to TAS-115 administration. 13 out of 21 pts (62%) showed more than 5% change, and more than 10% change was observed in 4 pts. Moreover, a total of 10 pts who had prior standard therapy maintained until Week 26. The most common drug-related AEs were rash (54%) and eyelid oedema (44%). Conclusion: TAS-115 showed a remarkable clinical response in % FVC over the 13-week treatment period with manageable safety profile. TAS-115 could be a novel therapeutic agent after standard therapy for IPF.