Phase 3 FIGHT-302 Results Presented at ASCO 2026 Evaluate Pemigatinib as a Potential First-Line Treatment Approach for Patients with FGFR2 Fusion- or Rearrangement-Positive Cholangiocarcinoma
Incyte’s pemigatinib demonstrated a statistically significant improvement in progression-free survival compared with standard chemotherapy
FOR IMMEDIATE RELEASE
June 12, 2026
Karen Templeton
Senior Director of Communications
[email protected]
Allison Deragon
Digital Media Manager
[email protected]
FOR IMMEDIATE RELEASE
CHICAGO, Ill. — Results presented at the 2026 American Society of Clinical Oncology (ASCO®) Annual Meeting mark a potentially practice-changing advance for patients with cholangiocarcinoma (bile duct cancer).
Investigational data from the Phase 3 FIGHT-302 (NCT03656536) trial showed that pemigatinib (Pemazyre®), significantly improved progression-free survival in the first-line setting 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-202.
The study represents the largest, first-line, randomized Phase 3 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 tumors more often than standard chemotherapy.,” said Tanios S. Bekaii-Saab, M.D., 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 personalized care.”
Approved under accelerated approval by the U.S. Food and Drug Administration (FDA) in 2020, pemigatinib became the first targeted therapy approved for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement. The FIGHT-302 findings further validate the role of precision medicine in the treatment of cholangiocarcinoma. The use of pemigatinib as a first-line treatment for FGFR2-positive cholangiocarcinoma is investigational and has not been approved by the FDA.
“The FIGHT-302 study confirms the high efficacy of FGFR2-targeted therapy in FGFR2 fusion-positive cholangiocarcinoma and further supports its use as a standard treatment option,” said Arndt Vogel, M.D., Ph.D., one of the investigators on the study and Professor and Clinician Scientist in the Division of Gastroenterology and Hepatology at the University of Toronto and the Joint Division of Gastroenterology and Hepatology at University Health Network and the Toronto Center for Liver Disease. “The magnitude of benefit also suggests that FGFR inhibition may be a valuable alternative for selected patients who cannot tolerate or wish to avoid chemotherapy in the first line. In addition, the high response rates raise the possibility of downstaging patients with borderline resectable disease. Overall, the results highlight the importance of routine molecular testing for FGFR2 alterations as early as possible.”
The results underscore the growing importance of comprehensive biomarker testing for all patients diagnosed with cholangiocarcinoma. Approximately 6% to 10% of patients with intrahepatic cholangiocarcinoma harbor FGFR2 fusions or rearrangements that may be targetable with precision therapies.
“At the Cholangiocarcinoma Foundation, we educate patients about the importance of biomarker testing,” said Stacie Lindsey, the Foundation’s Founder and CEO. “This study underscores how imperative this testing is to get the right treatment as soon as possible after diagnosis.”
As the treatment landscape for cholangiocarcinoma continues to evolve, studies such as FIGHT-302 demonstrate how molecular profiling can help identify patients most likely to benefit from targeted therapies and potentially improve outcomes beyond those achieved with traditional chemotherapy alone.
CCF encourages patients and their caregivers to connect with one of their Patient Advocates for guidance on biomarker testing, support resources, and treatment options. Patient Advocates can be reached at [email protected].
About cholangiocarcinoma:
Cholangiocarcinoma, pronounced (koh-LAN-jee-oh-KAR-sih-NOH-muh), is a highly lethal and rare bile duct cancer of the liver with a poor prognosis. With approximately 10,000 cases a year being diagnosed in the United States, cholangiocarcinoma is the second most common primary liver cancer in the world. It is often diagnosed at advanced stages when treatment is only minimally effective, emphasizing the imminent need for novel therapies.
About the Cholangiocarcinoma Foundation:
Founded in 2006, the Cholangiocarcinoma Foundation is a global 501(c)(3) non-profit organization. Its mission is to find a cure and improve the quality of life for patients with cholangiocarcinoma. The Foundation is also part of a global alliance and partners with institutions in the United Kingdom, Thailand, Italy, Denmark, Japan, and other countries. For more information, please visit our website at curecca.org. You may also contact CCF Director of Communications Karen Templeton at [email protected].
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