Primary analysis of the pivotal, single-arm, phase 2 FOENIX-CCA2 study demonstrated that the FGFR1-4 inhibitor futibatinib as second-line treatment yielded durable objective responses in patients with intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusion/rearrangements. At data cutoff (October 1, 2020) of the primary analysis, an objective response rate (ORR) of 41.7% was reported with a median duration of response (DOR) of 9.7 months.1 With an additional 8 months of follow-up, final analysis results including efficacy and safety data of the trial were recently reported at the 2022 ASCO annual meeting.
The FOENIX-CCA2 study enrolled patients with advanced/metastatic iCCA with an FGFR2 fusion/rearrangement and progressive disease after ≥1 prior treatments, including gemcitabine plus platinum-based chemotherapy. Eligible patients received 20 mg of futibatinib once daily until progressive disease or intolerability. The primary end point was ORR by independent central review; secondary end points were DOR, disease control rate (DCR), progression-free survival (PFS), overall survival (OS), safety, and patient-reported outcomes. The data cutoff date was May 29, 2021.
A total of 103 patients were enrolled in the study. The median age of the study population was 58 years; the majority were female (56%), had received ≥2 prior treatments (53%), and harbored FGFR2 fusions (78%). At data cutoff, 96 of the 103 patients (93%) had discontinued treatment. The median number of treatment cycles was 13 for a median treatment duration of 9.1 months.
At a median follow-up of 25 months, the confirmed ORR was 41.7% (1 complete response [CR], 42 partial responses [PRs]) and DCR was 82.5% (1 CR, 42 PRs, 42 stable disease), which was the same as previously reported in the primary analysis. The median DOR was 9.5 months, and median time to response was 2.6 months. Median PFS was 8.9 months, with a 12-month PFS rate of 35.4%. Mature median OS was 20.0 months, with a 12-month OS rate of 73.1%.
No new safety signals were identified. Common treatment-related adverse events (TRAEs) included hyperphosphatemia (85%), alopecia (33%), dry mouth (30%), diarrhea (28%), dry skin (27%), and fatigue (25%). Treatment discontinuation due to TRAEs was reported in 4 patients. No treatment-related deaths occurred.
Quality-of-life (QOL) assessments were performed using the EuroQoL visual analog scale, and QOL was maintained from baseline to 9 months (treatment cycle 13).
Goyal and colleagues found that the results of the final analysis of FOENIX-CCA2 were consistent with those of the primary analysis, indicating durable efficacy and continued tolerability of futibatinib in previously treated patients with advanced/metastatic iCCA harboring FGFR2 fusion/rearrangements. The authors noted that the mature OS data far exceeded historical data in this patient population.
Source: Goyal L, Meric-Bernstam F, Hollebecque A, et al. Updated results of the FOENIX-CCA2 trial: efficacy and safety of futibatinib in intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 fusions/rearrangements. Abstract 4009.
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