A potentially practice-changing advance in bile duct cancer
Results presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from the Phase III FIGHT-302 trial showed that Incyte’s pemigatinib (Pemazyre), significantly improved progression-free survival in the first-line setting in cholangiocarcinoma (bile duct cancer).
The drug was compared with gemcitabine and cisplatin, a long-standing standard chemotherapy regimen for advanced biliary tract cancers, in patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.
Patients receiving pemigatinib experienced a 42% reduction in the risk of disease progression or death compared with those receiving chemotherapy. Median progression-free survival was 8.3 months with pemigatinib versus 6.8 months with chemotherapy.
The median duration of response was more than doubled, at 14.2 months compared with 6.3 months. Additionally, estimated median PFS in the 42 patients who crossed over to second-line pemigatinib (after receiving Gem/Cis) was 8.1 months.
These results are consistent with the use of pemigatinib following disease progression on chemotherapy for patients with FGFR2 fusion- or rearrangement-positive cholangiocarcinoma, as demonstrated in FIGHT-302.
The study represents the largest, first-line, randomised Phase III trial in patients with cholangiocarcinoma with FGFR2 fusions or rearrangements, and demonstrated that a biomarker-driven targeted therapy may improve outcomes compared with chemotherapy in the frontline treatment setting in this genetically defined population.
“For patients with advanced bile duct cancer that have FGFR2 fusions or rearrangements, pemigatinib helped keep the cancer under control longer and shrank tumours more often than standard chemotherapy,” said Tanios Bekaii-Saab, the lead investigator on the study and the David F and Margaret T Grohne Professor of Novel Therapeutics for Cancer Research I at Mayo Clinic College of Medicine and Science, and Division Chair of Hematology/Medical Oncology at Mayo Clinic in Phoenix, Arizona. “These results suggest that pemigatinib may offer an effective first-line treatment option for this group of patients and represent an important step toward more personalised care.”