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Authors Lipika Goyal, Funda Meric-Bernstam, Antoine Hollebecque, Chigusa Morizane, Juan W. Valle, Thomas Benjamin Karasic, Thomas Adam Abrams, Robin Kate Kelley, Philippe Alexandre Cassier, Junji Furuse, Heinz-Josef Klümpen, Heung-Moon Chang, Li-Tzong Chen, Yoshito Komatsu, Kunihiro Masuda, Daniel H. Ahn, Kate Li, Karim A. Benhadji, Volker Wacheck, John A. Bridgewater
Title Updated results of the FOENIX-CCA2 trial: Efficacy and safety of futibatinib in intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions/rearrangements.
Journal Journal of Clinical Oncology
Vol 40
Issue no. 16_suppl
Date
URL https://ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.4009
Abstract Text Background: Survival outcomes are historically poor in patients (pts) with advanced/metastatic iCCA, with median overall survival (mOS) times of approximately 1 year with first-line gemcitabine plus cisplatin and approximately 6 months with second-line chemotherapy. Futibatinib, a highly selective, irreversible FGFR1–4 inhibitor, demonstrated efficacy with durable responses in pts with iCCA harboring FGFR2 fusion/rearrangements in the pivotal FOENIX-CCA2 phase 2 study (NCT02052778). At the primary analysis of this trial (data cutoff: October 1, 2020), an objective response rate (ORR) of 41.7% was observed, with a median duration of response (mDOR) of 9.7 mo. Here, we report updated efficacy (including mature OS data) and safety data from the final analysis with an additional 8 mo of follow-up. Methods: FOENIX-CCA2 was a single-arm phase 2 study that enrolled pts with advanced/metastatic iCCA with FGFR2 fusion/rearrangement and progressive disease (PD) after ≥1 prior treatment (tx; including gemcitabine plus platinum-based chemotherapy). Pts received futibatinib 20 mg once daily until PD/intolerability. The primary endpoint was ORR per RECIST v1.1 by independent central review. Secondary endpoints were DOR, disease control rate (DCR), progression-free survival (PFS), OS, safety, and patient-reported outcomes. Results: At the time of the final data cutoff (May 29, 2021), median follow-up was 25.0 mo, and 96/103 pts (93%) had discontinued tx. The median number of tx cycles was 13.0 for a median tx duration of 9.1 mo. The confirmed ORR was 41.7% (43/103) and thereby the same as of the primary analysis, as was the DCR (at 82.5%). The ORR was consistent across pt subgroups. The mDOR was 9.5 mo, and 74% of responses lasted ≥6 mo. mPFS was 8.9 mo, with a 12-mo PFS rate of 35.4%. Mature mOS was 20.0 mo, with a 12-mo OS rate of 73.1%. No new safety signals were identified. Common tx-related adverse events (TRAEs) included hyperphosphatemia (85%), alopecia (33%), dry mouth (30%), diarrhea (28%), dry skin (27%), and fatigue (25%). TRAEs resulted in tx discontinuation in 4 pts (4%). No tx-related deaths occurred. Quality of life was maintained from baseline to tx cycle 13. Conclusions: Findings from the final analysis of FOENIX-CCA2 confirm the results of the primary analysis and reinforce the durable efficacy and continued tolerability of futibatinib in previously treated pts with advanced/metastatic iCCA harboring FGFR2 fusion/rearrangements. Mature OS data were consistent with data from the primary analysis and far exceed historical data in this patient population. Clinical trial information: NCT02052778.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR2 rearrange intrahepatic cholangiocarcinoma predicted - sensitive Futibatinib FDA approved Actionable In a Phase II trial (FOENIX-CCA2) that supported FDA approval, Lytgobi (futibatinib) demonstrated a manageable toxicity profile and resulted in an objective response rate of 41.7% (43/103), a disease control rate of 82.5% in patients with advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions or other rearrangements, with a median progression-free survival of 8.9 mo and median overall survival of 20.0 mo (J Clin Oncol 40, no. 16_suppl (June 01, 2022) 4009; NCT02052778). detail... detail...
FGFR2 fusion intrahepatic cholangiocarcinoma predicted - sensitive Futibatinib FDA approved Actionable In a Phase II trial (FOENIX-CCA2) that supported FDA approval, Lytgobi (futibatinib) demonstrated a manageable toxicity profile and resulted in an objective response rate of 41.7% (43/103), a disease control rate of 82.5% in patients with advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusions or other rearrangements, with a median progression-free survival of 8.9 mo and median overall survival of 20.0 mo (J Clin Oncol 40, no. 16_suppl (June 01, 2022) 4009; NCT02052778). detail... detail...