marked.bio

FGFR inhibitor (irreversible) · small molecule

futibatinib

2 active trials across 4 of our biomarkers, targeting FGFR1-4 (covalent). 2 active approvals for a biomarker on marked.bio.

Also known as TAS-120, Lytgobi.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
futibatinib
EU (EMA), 2023
locally advanced or metastatic, FGFR2 fusion or rearrangement, after >=1 prior line of systemic therapy EU conditional authorisation 04/07/2023. Source
Lytgobi 		FGFR2 fusion or rearrangement cholangiocarcinoma Not approved Approved 2023 conditional

FOENIX-CCA2 (TAS-120-101) single-arm, 103 patients
Response 42%Lasting almost 10 months on average

Trial details and side effects
Patients
previously treated FGFR2 fusion/rearrangement intrahepatic cholangiocarcinoma (NCT02052778)
Most common side effects
nail toxicity, musculoskeletal pain, constipation, diarrhoea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, taste changes
Notes
EU figures from the EPAR summary; trial details and side effects from the US approval.
Source
EU summary (EPAR)
futibatinib
FDA, 2022
previously treated, unresectable locally advanced or metastatic intrahepatic, FGFR2 fusion or other rearrangement FDA accelerated approval 30/09/2022. Source
Lytgobi 		FGFR2 fusion or rearrangement cholangiocarcinoma (intrahepatic) Approved 2022 accelerated Not approved

FOENIX-CCA2 (TAS-120-101) single-arm, 103 patients
Response 42% (32-52)Lasting 9.7 months

Trial details and side effects
Patients
previously treated FGFR2 fusion/rearrangement intrahepatic cholangiocarcinoma (NCT02052778)
Most common side effects
nail toxicity, musculoskeletal pain, constipation, diarrhoea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, taste changes
Notes
FDA approval as reported by ASCO Post (2022); side effects are those in 20% or more of patients.
Source
US approval report

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
FGFR2 fusion or rearrangement 1 4 Phase 2
KRAS G12C 1 2 Phase 1
KRAS G12D 1 2 Phase 1
FGFR3 alteration (mutation or fusion) 0 3 –

Sponsors

Industry sponsors leading active biomarker-selected trials of futibatinib.

  1. Taiho Pharmaceutical 2

Trials

2 of 6 trials shown

  1. Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

    Recruiting Phase 2 Taiho Pharmaceutical Started 2023Primary completion 2026-12 NCT05727176

    futibatinib FDA EU

    Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement

    FGFR2 fusion or rearrangementAdvanced Cholangiocarcinoma, FGFR2 Fusions, Gene Rearrangement

  2. AB122 Platform Study

    Recruiting Phase 1 Taiho Pharmaceutical Started 2021Primary completion 2027-06 NCT04999761

    zimberelimabTAS-116futibatinibTAS-115trifluridine/tipiracilramucirumabbevacizumabfluorouracilcisplatinAB154carboplatinnab-paclitaxel

    …ras) oncogene homolog (NRAS) (exon 2, 3 and 4) wild type. \[Mutant is defined as at least KRAS or NRAS mutant (any exon, any mutation)\].

    KRAS G12CKRAS G12DAdvanced or Metastatic Solid Tumor, Pancreatic Ductal Adenocarcinoma, Colorectal Cancer, Non-small Cell Lung Cancer