Quality of life (QoL) outcomes with futibatinib treatment in FOENIX-CCA2 - A phase II study in patients (pts) with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions/rearrangements

Abstract

Background: Cancer treatment can produce AEs that result in a reduced QoL. Futibatinib, a highly selective irreversible FGFR1e4 inhibitor, demonstrated an objective response rate (ORR) of 37.3% and median 8.3-mo duration of response in the interim analysis of FOENIX-CCA2, a mutlicenter phase II trial of pts with advanced, refractory iCCA harboring an FGFR2 fusion/rearrangement; grade 3 treatment-related AEs (TRAEs) occurred in 57% of pts (most commonly, hyperphosphatemia [26.9%]). Change in pt-reported outcomes (PROs) from baseline (BL) for the interim data of the phase II trial are presented here. Methods: Pts enrolled into FOENIX-CCA2 (NCT02052778), had locally advanced/ metastatic unresectable iCCA and received oral futibatinib 20 mg once daily (QD) until disease progression/intolerance. PRO measures included EORTC-QLQ-C30 (5 functional and 9 physical measures) and EQ-5D-3L (utility index and 5 dimensions: anxiety/ depression, mobility, pain/discomfort, self-care, and usual activity). PROs were collected at screening, cycles 2 and 4, every 3 cycles after cycle 4 and at the end of treatment. Change in mean score from BL was assessed using predefined clinically meaningful thresholds for each time point with 19 observations (through cycle 13). Results: Sixty-seven of 103 enrolled pts had 6 months of follow-up and 57 (85.1%) had PRO completion data at BL and 1 assessment. EORTC mean global health status score was high at BL (68.7) and maintained through cycle 13 (70.8), a trend observed across all EORTC measures. The only clinically meaningful changes ( 10-point changes) in this timeframe were for constipation symptoms at cycles 2 and 4 (worsened +12.4 and +10.7, respectively) and dyspnea at cycle 10 (improved -12.2). Mean EQ-5D-3L index scores improved from 70.9 at BL to 79.1 at cycle 13 (approximately 273 days on treatment). Conclusions: Overall, the interim PROs from FOENIX-CCA2 were encouraging. These data suggest that despite the occurrence of TRAEs, a 20-mg-QD dose of futibatinib in pts with iCCA provides a promising clinical response without adversely impacting QoL.