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For U.S. Healthcare Professionals

Efficacy and safety assessed in the FOENIX-CCA2 trial1-3

FOENIX-CCA2 (TAS-120-101) was a multicenter, open-label, single-arm, phase 2 study in patients with previously treated, unresectable, locally advanced or metastatic iCCA harboring an FGFR2 fusion or rearrangement.1,2

PATIENTS (N=103)2

Key eligibility criteria

  • Unresectable or metastatic iCCA
  • FGFR2 fusions or other rearrangements
  • Measurable disease per RECIST v1.1
  • Prior gemcitabine + platinum-based chemotherapy
  • Progression after ≥1 systemic therapy
  • ECOG PS 0 or 1
  • No prior treatment with FGFR inhibitor

TREATMENT1-3

LYTGOBI tablets 20 mg orally once daily, continuously

Treatment was administered until disease progression, drug intolerance, withdrawal of consent, or death.

A maximum of 2 dose reductions (to 16 mg and then to 12 mg) were permitted to manage treatment-emergent ARs.a

Note: Prophylactic treatment was not administered for hyperphosphatemia.3

ENDPOINTS1,3

Primary (by IRC):

  • Overall response rate

Secondary:

  • Duration of response
  • DCR
  • PFS
  • OS
  • Safety
  • Patient-reported outcomes

FOLLOW-UP2

Follow-up continued for up to 18 months after enrollment of last patient.

  • aTreatment was discontinued if treatment-emergent ARs did not resolve after 2 dose modifications or if the next cycle of treatment was delayed >21 days.2

Targeting patients with FGFR2 aberrations

Patient baseline characteristics1,2

Baseline
characteristics		 Category All PATIENTS (N=103)
Age, years (median range) – 58
(22-79)
  • 22% of patients ≥65 years
Sex (%) Female 56
Male 44
Race (%) White 50
Asian 29
Black or African American 8
Native Hawaiian or Other Pacific Islander 1
Unknown 13
ECOG PS (%) 0 47
1 53
Number of
prior regimens
(%)		 At least 1 100
2 30
≥3 23
FGFR2
aberrationb (%)		 Fusions 78
Rearrangements 22
  • bDetermined by Foundation Medicine Central (n=68), Foundation Medicine Local reports (n=25), or by local testing (n=10); 2 patients had FGFR2 mutations in addition to fusions.4
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AR=adverse reaction; DCR=disease control rate; ECOG PS=Eastern Cooperative Oncology Group performance status; FGFR=fibroblast growth factor receptor; iCCA=intrahepatic cholangiocarcinoma; IRC=independent review committee; OS=overall survival; PFS=progression-free survival; RECIST v1.1=Response Evaluation Criteria for Solid Tumors version 1.1.

References:

1. 

LYTGOBI [package insert]. Princeton, NJ: Taiho Oncology, Inc.; 2022.

2. 

Bridgewater J, Meric-Bernstam F, Hollebecque A, et al. Efficacy and safety of futibatinib in intrahepatic cholangiocarcinoma harboring FGFR2 fusions/rearrangements: subgroup analyses of a phase 2 study (FOENIX-CCA2). Poster presented at: European Society for Medical Oncology 2020 Virtual Congress; September 19-21, 2020; Switzerland. 2020;17(9):557-588.

3. 

Goyal L, Meric-Bernstam F, Hollebecque A, et al. Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma. N Engl J Med. 2023;388(3):228-239.

4. 

Goyal L, Meric-Bernstam F, Hollebecque A, et al. Primary results of phase 2 FOENIX-CCA2: the irreversible FGFR1–4 inhibitor futibatinib in intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements. Abstract presented at: American Association for Cancer Research Annual Meeting; April 10-15, 2021, and May 17-21, 2021. Abstract CT010.

INDICATIONS AND USAGE

INDICATION AND USAGE

LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
  • Ocular Toxicity: LYTGOBI can cause Retinal Pigment Epithelial Detachment (RPED), which may cause symptoms such as blurred vision. RPED occurred in 9% of 318 patients who received LYTGOBI across clinical trials. The median time to first onset of RPED was 40 days. RPED led to dose interruption of LYTGOBI in 1.3% of patients, dose reduction in 1.6% of patients, and permanent discontinuation in 0.3% of patients. Perform a comprehensive ophthalmological examination, including optical coherence tomography (OCT) of the macula, prior to initiation of therapy, every 2 months for the first 6 months, and every 3 months thereafter. For onset of visual symptoms, refer patients for ophthalmologic evaluation urgently, with follow-up every 3 weeks until resolution or discontinuation of LYTGOBI. Withhold or reduce the dose of LYTGOBI as recommended. Dry Eye/Corneal Keratitis: Among 318 patients who received LYTGOBI across clinical trials, dry eye occurred in 15% of patients. Treat patients with ocular demulcents as needed.
  • Hyperphosphatemia and Soft Tissue Mineralization: LYTGOBI can cause hyperphosphatemia leading to soft tissue mineralization, calcinosis, nonuremic calciphylaxis, and vascular calcification. Hyperphosphatemia was reported in 88% of 318 patients treated with LYTGOBI across clinical trials with a median time of onset of 5 days (range 3‑117). Phosphate binders were received by 77% of patients who received LYTGOBI. Monitor for hyperphosphatemia throughout treatment. Initiate a low-phosphate diet and phosphate-lowering therapy when serum phosphate level is ≥5.5 mg/dL; initiate or intensify phosphate-lowering therapy when >7 mg/dL; reduce dose, withhold, or permanently discontinue LYTGOBI based on duration and severity of hyperphosphatemia.
  • Embryo-fetal Toxicity: Based on findings in an animal study and its mechanism of action, LYTGOBI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise female patients of reproductive potential, and males with female partners of reproductive potential, to use effective contraception during treatment with LYTGOBI and for 1 week after the last dose.

ADVERSE REACTIONS
  • Serious adverse reactions occurred in 39% of patients receiving LYTGOBI, and in ≥2% of patients included pyrexia, gastrointestinal hemorrhage, ascites, musculoskeletal pain, and bile duct obstruction.
  • The most common adverse reactions (≥20%) were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting.
  • The most common laboratory abnormalities (≥20%) were increased phosphate, increased creatinine, decreased hemoglobin, increased glucose, increased calcium, decreased sodium, decreased phosphate, increased alanine aminotransferase, increased alkaline phosphatase, decreased lymphocytes, increased aspartate aminotransferase, decreased platelets, increased activated partial thromboplastin time, decreased leukocytes, decreased albumin, decreased neutrophils, increased creatine kinase, increased bilirubin, decreased glucose, increased prothrombin international normalized ratio, and decreased potassium.

DRUG INTERACTIONS
  • Dual P-gp and Strong CYP3A Inhibitors: Avoid concomitant use of drugs that are dual P-gp and strong CYP3A inhibitors.
  • Dual P-gp and Strong CYP3A Inducers: Avoid concomitant use of drugs that are dual P-gp and strong CYP3A inducers.

USE IN SPECIFIC POPULATIONS
  • Lactation: Because of the potential for serious adverse reactions from LYTGOBI in breastfed children, advise women not to breastfeed during treatment and for 1 week after the last dose.

Please see accompanying full Prescribing Information for complete details.

Important Safety Information

INDICATION AND USAGE

LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS
  • Ocular Toxicity: LYTGOBI can cause Retinal Pigment Epithelial Detachment (RPED), which may cause symptoms such as blurred vision. RPED occurred in 9% of 318 patients who received LYTGOBI across clinical trials. The median time to first onset of RPED was 40 days. RPED led to dose interruption of LYTGOBI in 1.3% of patients, dose reduction in 1.6% of patients, and permanent discontinuation in 0.3% of patients. Perform a comprehensive ophthalmological examination, including optical coherence tomography (OCT) of the macula, prior to initiation of therapy, every 2 months for the first 6 months, and every 3 months thereafter. For onset of visual symptoms, refer patients for ophthalmologic evaluation urgently, with follow-up every 3 weeks until resolution or discontinuation of LYTGOBI. Withhold or reduce the dose of LYTGOBI as recommended. Dry Eye/Corneal Keratitis: Among 318 patients who received LYTGOBI across clinical trials, dry eye occurred in 15% of patients. Treat patients with ocular demulcents as needed.
  • Hyperphosphatemia and Soft Tissue Mineralization: LYTGOBI can cause hyperphosphatemia leading to soft tissue mineralization, calcinosis, nonuremic calciphylaxis, and vascular calcification. Hyperphosphatemia was reported in 88% of 318 patients treated with LYTGOBI across clinical trials with a median time of onset of 5 days (range 3‑117). Phosphate binders were received by 77% of patients who received LYTGOBI. Monitor for hyperphosphatemia throughout treatment. Initiate a low-phosphate diet and phosphate-lowering therapy when serum phosphate level is ≥5.5 mg/dL; initiate or intensify phosphate-lowering therapy when >7 mg/dL; reduce dose, withhold, or permanently discontinue LYTGOBI based on duration and severity of hyperphosphatemia.
  • Embryo-fetal Toxicity: Based on findings in an animal study and its mechanism of action, LYTGOBI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise female patients of reproductive potential, and males with female partners of reproductive potential, to use effective contraception during treatment with LYTGOBI and for 1 week after the last dose.

ADVERSE REACTIONS
  • Serious adverse reactions occurred in 39% of patients receiving LYTGOBI, and in ≥2% of patients included pyrexia, gastrointestinal hemorrhage, ascites, musculoskeletal pain, and bile duct obstruction.
  • The most common adverse reactions (≥20%) were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting.
  • The most common laboratory abnormalities (≥20%) were increased phosphate, increased creatinine, decreased hemoglobin, increased glucose, increased calcium, decreased sodium, decreased phosphate, increased alanine aminotransferase, increased alkaline phosphatase, decreased lymphocytes, increased aspartate aminotransferase, decreased platelets, increased activated partial thromboplastin time, decreased leukocytes, decreased albumin, decreased neutrophils, increased creatine kinase, increased bilirubin, decreased glucose, increased prothrombin international normalized ratio, and decreased potassium.

DRUG INTERACTIONS
  • Dual P-gp and Strong CYP3A Inhibitors: Avoid concomitant use of drugs that are dual P-gp and strong CYP3A inhibitors.
  • Dual P-gp and Strong CYP3A Inducers: Avoid concomitant use of drugs that are dual P-gp and strong CYP3A inducers.

USE IN SPECIFIC POPULATIONS
  • Lactation: Because of the potential for serious adverse reactions from LYTGOBI in breastfed children, advise women not to breastfeed during treatment and for 1 week after the last dose.

Please see accompanying full Prescribing Information for complete details.