The Lynx Group
Cholangiocarcinoma News

Updated Results of the FIGHT-202 Study Reinforced the Efficacy and Safety of Pemigatinib for Previously Treated Locally Advanced/Metastatic CCA

2021 Year in Review: Cholangiocarcinoma — December 17, 2021

Updated results from the FIGHT-202 study supported the primary data that second-line pemigatinib treatment resulted in efficacy and sustained tolerability in patients with CCA harboring FGFR2 rearrangements/fusions.

FIGHT-202 is a single-arm, phase 2, open-label, multicenter study ( Identifier: NCT02924376) that investigated the efficacy and safety of the selective, oral FGFR1-3 inhibitor pemigatinib in patients with previously treated advanced/metastatic cholangiocarcinoma (CCA) who had progressed on ≥1 prior therapies. Mature efficacy and safety data from the FIGHT-202 trial were reported at the 2021 American Society of Clinical Oncology Annual Meeting. Pemigatinib was approved in 2020 by the US Food and Drug Administration (FDA) for the treatment of adults with previously treated, unresectable locally advanced or metastatic CCA with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test.

In the FIGHT-202 study, eligible adults with disease progression after ≥1 prior treatments and documented FGF/FGFR gene status were assigned to cohort A (FGFR2 gene rearrangements/fusions), cohort B (other FGF/FGFR gene alterations), or cohort C (no FGF/FGFR gene alterations). All eligible patients received oral pemigatinib 13.5 mg once daily (21-day cycle; 2 weeks on, 1 week off) until disease progression or unacceptable toxicity. The primary end point was the centrally confirmed objective response rate (ORR) of cohort A. Secondary end points included ORR (cohort B, cohorts A and B combined, and cohort C), duration of response (DOR), duration of complete response, progression-free survival, overall survival (OS), and safety. A post-hoc analysis was conducted in cohort A to evaluate median OS in responders compared with nonresponders. The data cutoff date for this analysis was April 7, 2020.

At data cutoff, the current analysis included a total of 147 patients. Of these participants, 108 were enrolled in cohort A, 20 in cohort B, and 17 in cohort C. At a median follow-up of 30.4 months, the median treatment duration was 5.9 months and 9.3% of patients remained on therapy in cohort A. The centrally confirmed ORR in cohort A was 37.0%, including 4 complete responders and 36 partial responders. The median DOR was 8.1 months (95% confidence interval, 5.7-13.1). No responses were reported in cohorts B and C. The updated median OS was 17.5 months, which was longer than that in historical data. Furthermore, post-hoc analysis revealed that the median OS was prolonged for responders (n = 40; 30.1 months) compared with nonresponders (n = 68; 13.7 months) in cohort A.

The safety profile in the current analysis was similar to that in the primary analysis, and no new safety signals were observed. In the total population, the most frequently reported treatment-emergent adverse events (TEAEs) included hyperphosphatemia (58.5%), alopecia (49.7%), diarrhea (46.9%), fatigue (43.5%), nausea (41.5%), and dysgeusia (40.8%). TEAEs led to treatment discontinuation in 10.2% of patients and treatment interruption in 42.2% of participants.

These results supported primary data and indicated that pemigatinib treatment was associated with continued and durable responses, along with sustained tolerability, in patients with CCA who harbor FGFR2 rearrangements/fusions.

Source: Abou-Alfa GK, Sahia V, Hollebecque A, et al. Pemigatinib for previously treated locally advanced/metastatic cholangiocarcinoma (CCA): update of FIGHT-202. J Clin Oncol. 2021;39(suppl_15):4086-4086.

Related Items

Phase 1 Results of Gunagratinib in Patients with Advanced Solid Tumors Harboring FGFR Pathway Alterations
2021 Year in Review: Cholangiocarcinoma
A phase 1/2a, first-in-human clinical study demonstrated that the highly selective, irreversible pan-FGFR inhibitor gunagratinib was safe and well-tolerated in patients with advanced solid tumors, including CCA.
Prognostic Value of FGFR2 Alterations in Patients Receiving Systemic Chemotherapy for Intrahepatic CCA
2021 Year in Review: Cholangiocarcinoma
A retrospective analysis indicated the prognostic value of FGFR2 fusions/rearrangements in patients with intrahepatic CCA receiving systemic chemotherapy, which warrants additional study.
FGFR2 Fusion and/or Rearrangement Profiling in Chinese Patients with Intrahepatic CCA
2021 Year in Review: Cholangiocarcinoma
Epidemiologic data assessed the incidence rate of FGFR2 gene fusion or rearrangement in Chinese patients with intrahepatic CCA, including those with heterogeneous FGFR2 partner genes.
A Comprehensive Genomic and Immune Profiling Study of IDH1- and IDH2-Driven Intrahepatic CCA
2021 Year in Review: Cholangiocarcinoma
A comprehensive genomic and immune characterization of IDH-mutated and wild-type intrahepatic CCA revealed significant differences in genetic alterations.
Characteristics of IDH Mutations in Bile Duct Carcinoma in a Chinese Population
2021 Year in Review: Cholangiocarcinoma
A retrospective analysis in a large Chinese patient cohort with bile duct carcinoma indicated that activating IDH1/2 mutations occurred at a lower rate compared with that previously reported in the global population.
Silmitasertib (CX-4945) plus Gemcitabine and Cisplatin as First-Line Treatment for Patients with Locally Advanced or Metastatic CCA
2021 Year in Review: Cholangiocarcinoma
Preliminary evidence suggests that combination treatment with silmitasertib plus gemcitabine/cisplatin as first-line therapy has promising efficacy and a favorable safety profile in patients with locally advanced or metastatic CCA.
Targeted Therapies in CCA: Assessment of US Oncologist Practice Patterns
2021 Year in Review: Cholangiocarcinoma
Findings from a clinical practice assessment identified gaps in knowledge, competence, and confidence regarding testing and the use of targeted therapies in patients with unresectable CCA, underscoring the important role of education in overcoming these gaps.
First-Line Toripalimab plus Lenvatinib in Combination with GemOx Chemotherapy for Advanced Intrahepatic CCA
2021 Year in Review: Cholangiocarcinoma
Results of a phase 2 study indicate that toripalimab and lenvatinib in combination with GemOx chemotherapy provide antitumor activity and reasonable tolerability in patients with advanced intrahepatic CCA.
Comparative Landscape of Actionable Somatic Alterations in Advanced CCA from Circulating Tumor and Tissue-Based DNA Profiling
2021 Year in Review: Cholangiocarcinoma
Findings from a retrospective analysis support the use of both tissue and liquid biopsy biomarker testing to guide therapy selection in patients with advanced CCA, particularly when tissue may not be readily available.
Tibsovo (Ivosidenib) FDA Approved for Advanced or Metastatic Cholangiocarcinoma and IDH1 Mutation
By Loretta Fala
2021 Year in Review: Cholangiocarcinoma
Cholangiocarcinoma (CCA) is an aggressive cancer of the bile duct that forms inside the liver (ie, intrahepatic) or outside the liver (ie, extrahepatic, including perihilar and distal tumors). Individuals with colitis or certain liver diseases may have an increased risk for CCA. Although the precise incidence of CCA is unknown, an estimated 8000 new cases of CCA are diagnosed annually in the United States. It is likely, however, that this number is higher, because CCA is difficult to diagnose and may be misclassified at times.

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive: