Findings from a study in a Chinese patient population confirmed the efficacy and tolerability of pemigatinib in patients with recurrent or metastatic CCA with an FGFR2 fusion or rearrangement.
The current study was undertaken to determine whether the efficacy and safety data on pemigatinib obtained from the FIGHT-202 study could be extrapolated to the Chinese patient population with cholangiocarcinoma (CCA). Results of the study were presented at the 2021 European Society for Medical Oncology Annual Congress.
The study enrolled patients aged ≥18 years with recurrent or metastatic CCA who had failed ≥1 lines of prior systemic therapy between February 26, 2020, and January 29. 2021. The study design incorporated 2 stages: In stage 1, there were 3 participants enrolled, regardless of the FGFR2 status, who were treated with pemigatinib 9 mg. In stage 2, a total of 31 patients were enrolled with an FGFR2 fusion or rearrangement and treated with pemigatinib 13.5 mg. Patients in both cohorts received pemigatinib once daily on a 2-weeks-on/1-week-off schedule, until disease progression, unacceptable toxicity, withdrawal of consent, or physician decision. The efficacy population included only patients enrolled in stage 2. The primary end point was objective response rate (ORR) assessed by an independent radiological review committee (IRRC) per RECIST version 1.1 in the 31 patients who were enrolled in stage 2.
At data cutoff (January 29, 2021), a total of 34 patients were enrolled in the study (stage 1: n = 3; stage 2: n = 31). The median age of the 34 participants was 55.5 years; the majority were female, had intrahepatic CCA (94.1%), and had stage IV disease.
The efficacy analysis included 30 evaluable patients from stage 2. With a median follow-up of 5.13 months, an ORR of 50% (95% confidence internal [CI], 31.3%-68.7%) was achieved, as assessed by IRRC, of whom 13 patients were still in response. The median duration of response was not reached (NR; 95% CI, 3.4-NR), and the median progression-free survival was 6.3 months (95% CI, 4.9-NR). The disease control rate was 100% (95% CI, 88.4%-100%).
The safety analysis included patients enrolled in both stages (N = 34). All 34 patients experienced ≥1 all-grade treatment-related adverse events (TRAEs); 14.7% reported grade ≥3 TRAEs. The most common TRAEs were hyperphosphatemia (73.5%), xerostomia (55.9%), and alopecia (50.0%). Three serious adverse events were reported—rectal polyps, abnormal liver function, and bile duct infection. No treatment discontinuation or deaths due to TRAEs were reported.
Based on these results, the investigators concluded that pemigatinib was highly effective and tolerable in the Chinese patient population with recurrent or metastatic CCA with an FGFR2 fusion or rearrangement.
Source: Shi GM, Huang XY, Wen TF, et al. Efficacy and safety of pemigatinib in Chinese patients with unresectable, advanced/recurrent or metastatic intrahepatic cholangiocarcinoma with FGFR2 fusion or rearrangement that failed to prior systemic therapy. Ann Oncol. 2021;32(suppl_5):S377.
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