News|Articles|May 21, 2026

FIGHT-302 Data to Detail Pemigatinib's Phase 3 Showing vs Chemo in Frontline FGFR2+ CCA at ASCO 2026

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Key Takeaways

Pemigatinib demonstrated statistically significant PFS improvement versus gemcitabine/cisplatin in FGFR2-rearranged cholangiocarcinoma, with HR 0.58 (P = .0078) despite modest absolute median PFS separation.
Response durability favored targeted therapy, with median duration of response 14.2 months on pemigatinib versus 6.3 months on chemotherapy, supporting meaningful disease-control extension in responders.
Overall survival was not improved (24.4 vs 25.0 months), raising considerations around crossover, subsequent-line FGFR inhibitors, and endpoint selection in molecularly selected biliary tract trials.
Trial eligibility required ECOG 0–1 and excluded prior systemic therapy, Child–Pugh B/C, ocular comorbidities, untreated CNS metastases, and recent strong CYP3A4 modulators, informing real-world generalizability.
Randomized phase 3 first-line evidence is positioned as a key step toward moving FGFR inhibition earlier and enabling permanent approval pathways beyond accelerated approvals in later-line settings.

Ahead of the 2026 ASCO Annual Meeting, results from the phase 3 FIGHT-302 study have been announced.

Ahead of the 2026 ASCO Annual Meeting, results from the highly anticipated phase 3 FIGHT-302 study (NCT03656536) have been announced.¹

Findings indicated that the median progression-free survival (PFS) with pemigatinib (Pemazyre; n = 83) was 8.3 months (95% CI, 6.5-12.2) in patients with untreated unresectable or metastatic cholangiocarcinoma (CCA) with FGFR2 rearrangements vs 6.8 months (95% CI, 6.1-8.3) with chemotherapy in the form of gemcitabine plus cisplatin (n = 84), translating to a 42% reduction in the risk of disease progression or death (HR, 0.58; 95% CI, 0.39-0.87; P = .0078), according to the abstract. The median duration of response in the respective arms was 14.2 months (95% CI, 8.7-24.7) and 6.3 months (95% CI, 4.3-not estimable). Moreover, the median overall survival (OS) was 24.4 months (95% CI, 18.6-35.9) with pemigatinib vs 25.0 months (95% CI, 18.7-34.2) with chemotherapy.

Why evaluate pemigatinib in the first-line CCA setting?

The original standard of care (SOC) for first-line treatment of unresectable, recurrent, or metastatic biliary tract cancer was cisplatin plus gemcitabine, based on results from the phase 3 ABC-02 trial (NCT00262769), which showed a median OS of 11.7 months and a median PFS of 8.0 months.² Attempts to improve on this backbone with the addition of cetuximab (Erbitux) to gemcitabine plus oxaliplatin and cediranib to gemcitabine plus cisplatin have not showcased additional survival benefit.^3,4However, the addition of immune checkpoint inhibitors to this backbone have resulted in improved outcomes, establishing a new SOC in this population.^5,6

What prior data have been reported with pemigatinib?

Pemigatinib received FDA approval for previously treated, unresectable locally advanced or metastatic CCA with an FGFR2 fusion or other rearrangement, becoming the first targeted therapy approved for CCA in April 2020.⁷ Based on the antitumor activity and manageable toxicities observed across FIGHT-101 (NCT02393248) and FIGHT-202 (NCT02924376), investigators hypothesized that pemigatinib could provide benefit when moved to the first-line setting in biomarker-selected patients.^8,9

What was the design of FIGHT-302?

FIGHT-302 enrolled patients with previously untreated metastatic CCA harboring FGFR2 rearrangement who were at least 18 years of age or older.¹⁰They had an ECOG performance status of 0 or 1. Key exclusion criteria include prior systemic therapy, Child–Pugh score B or C, clinically significant corneal or retinal disorders, untreated central nervous system metastases, and use of potent CYP3A4 inhibitors or inducers within 14 days or five half-lives before the first dose.

Patients were randomly assigned 1:1 to receive pemigatinib 13.5 mg orally once daily on a continuous 3-week cycle or gemcitabine 1000 mg/m² plus cisplatin 25 mg/m² intravenously on days 1 and 8 of each 3-week cycle for up to 8 cycles. Tumor assessments by computed tomography or MRI per RECIST 1.1 criteria were performed at baseline and every 9 weeks from cycle 3 onward.

The primary end point of the study was PFS.¹ Safety was also analyzed.

**What will the FIGHT-302 data mean for the role of pemigatinib in the frontline treatment of FGFR2-rearranged CCA?**

“Although [the phase 3 FIGHT-302 trial (NCT03656536)] stopped early, it remains the largest [dataset] with an FGFR inhibitor in the first line and in a randomized setting. With all the benefits we’ve seen with these FGFR inhibitors in later lines of therapy, whatever the results end up being, they’re going to be meaningful, one way or the other, for us to understand,” Tanios Bekaii-Saab, MD, FACP, said in an exclusive conference preview with OncLive®. “In the second [and] third line, [we have] pemigatinib [Pemazyre] and futibatinib [Lygtobi] approved in the United States on an accelerated basis,^2,3 and a number of other [agents] are being developed. A phase 3 study is essential for permanent approval. Also, at the end of the day, we haven’t had any first-line data, and this is the first large study at that scale.”

Tanios S. Bekaii-Saab, MD, of Mayo Clinic Arizona, will present the full data as part of a highly anticipated rapid oral abstract session on June 1, 2026.

References

Bekaii-Saab TS, Melisi D, Wilmink J, et al. Pemigatinib for untreated unresectable/metastatic cholangiocarcinoma (mCCA) with fibroblast growth factor receptor-2 (FGFR2) rearrangement: Phase 3 FIGHT-302 results. J Clin Oncol. 2026;44(suppl 16):4017. doi:10.1200/JCO.2026.44.16_suppl.4017
Valle J, Wasan H, Palmer DH, et al. Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med. 2010;362(14):1273-1281. doi:10.1056/NEJMoa0908721
Malka D, Cervera P, Foulon S, et al. Gemcitabine and oxaliplatin with or without cetuximab in advanced biliary-tract cancer (BINGO): a randomised, open-label, non-comparative phase 2 trial. Lancet Oncol. 2014;15(8):819-828. doi:10.1016/S1470-2045(14)70212-8
Valle JW, Wasan H, Lopes A, et al. Cediranib or placebo in combination with cisplatin and gemcitabine chemotherapy for patients with advanced biliary tract cancer (ABC-03): a randomised phase 2 trial. Lancet Oncol. 2015;16(8):967-978. doi:10.1016/S1470-2045(15)00139-4
FDA D.I.S.C.O. Burst Edition: FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancer. FDA. October 17, 2022. Accessed May 26, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-imfinzi-durvalumab-adult-patients-locally-advanced-or
FDA approves pembrolizumab with chemotherapy for biliary tract cancer. FDA. Updated November 1, 2023. Accessed May 26, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-chemotherapy-biliary-tract-cancer
FDA approves Incyte’s Pemazyre (pemigatinib) as first targeted treatment for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma. News release. Incyte. April 17, 2020. Accessed May 21, 2026. https://investor.incyte.com/news-releases/news-release-details/fda-approves-incytes-pemazyretm-pemigatinib-first-targeted
Roychowdhury S, Bhatt D, Scheuber D, et al. Phase I/II dose-finding study of pemigatinib (INCB054828) in patients with advanced malignancies (FIGHT-101). J Clin Oncol. 2019;37(suppl 15):3099. doi:10.1200/JCO.2019.37.15_suppl.3099
Abou-Alfa GK, Sahai V, Hollebecque A, et al. Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study. Lancet Oncol. 2020;21(5):671-684. doi:10.1016/S1470-2045(20)30109-1
Bekaii-Saab TS, Valle JW, Van Cutsem E, et al. FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with FGFR2 rearrangements. Future Oncol. 2020;16(30):2385-2399. doi:10.2217/fon-2020-0429