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Indication

TRUSELTIQ is indicated for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test.

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).

Clinical Study

TRUSELTIQ was studied in a phase 2, multicenter, open-label, single-arm trial of 108 adult patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma (CCA).1,2

Patient Population1


  • Patients with CCA who have an FGFR2 fusion or other rearrangement
  • ≥1 prior line of systemic therapy

TRUSELTIQ Monotherapy1


  • 125 mg orally, once daily
  • 21 consecutive days followed by 7 days off therapy, in 28-day cycles
  • Until disease progression or unacceptable toxicity

Primary Endpoints1*


  • Overall response rate (ORR)
  • Duration of response (DoR)

Baseline Patient Characteristics1-3


99% of patients were stage 4 at enrollment
Median age was 53 years. 62% were female. 38% were male
All patients had at least 1 prior line of systemic therapy prior to TRUSELTIQ

TRUSELTIQ showed clinically meaningful efficacy in a phase 2, multicenter, open-label, single-arm trial of 108 patients with 2L+ FGFR2 fusion-driven CCA1,3

TRUSELTIQ demonstrated antitumor activity in patients with previously treated, unresectable, locally advanced or metastatic disease1,3

Primary Endpoint

23% ORR
(N=108)
(95% CI: 16, 32)*

ORR=overall response rate.

Primary Endpoint

5 Months
Median DoR
(95% Cl: 4, 9)*

Graphs showing the primary endpoints of median time to response (3.6 months) and median duration of response (5 months).
  • 3.6 months median TTR (range 1.4-7.4)

DoR=duration of response; TTR=time to response.

Additional analyses were conducted in the study of TRUSELTIQ1-3


Prespecified subgroup analysis

Subgroup receiving only
≤1 prior line of therapy:

34% ORR
(n=50; 95% CI: 21, 49)*†

Subgroup receiving
2-8 prior lines of therapy:

14% ORR
(n=58; 95% CI: 6, 25)*†

Secondary endpoint

Graph showing the secondary endpoint of the disease control rate (84%) and the percentage break down.

Progressive disease, 10.2% and unknown, 5.6%.
Disease control rate (DCR) is the sum of complete response, partial response, and stable disease.

*As determined by blinded independent central review (BICR).1

Stable disease may be associated with the natural course of disease. The difference cannot be characterized in a single-arm study.4

Definition of prior line excludes perioperative therapies.3

Results from the prespecified subgroup analysis are limited by small sample sizes and wide confidence intervals.

The additional analyses are consistent with labeling, but are not included in the US Prescribing Information for TRUSELTIQ.

NCCN Guidelines Recommendations

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Recommend infigratinib (TRUSELTIQ) as a subsequent-line treatment option for unresectable or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements following disease progression5§II¶

§See the Guidelines online at NCCN.org for the full recommendation.

IINCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.

  NCCN=National Comprehensive Cancer Network.

Take a look at the TRUSELTIQ safety profile

References:
  1. TRUSELTIQ Prescribing Information. Brisbane, CA: QED Therapeutics, Inc.; May 2021.
  2. Javle M, et al. Lancet Gastroenterol Hepatol. Published Online August 3, 2021. https://doi.org/10.1016/S2468-1253(21)00196-5.
  3. Data on file TRUS-003.
  4. Food and Drug Administration. https://www.fda.gov/media/71195/download. Accessed July 8, 2021.
  5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hepatobiliary Cancers V.3.2021. ©National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed June 15, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

INDICATION AND IMPORTANT
SAFETY INFORMATION

INDICATION

TRUSELTIQ is indicated for the treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

Accelerated approval was granted based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

IMPORTANT SAFETY INFORMATION

Warnings and precautions

  • Ocular toxicity: Retinal pigment epithelial detachment (RPED), which may cause blurred vision, occurred in 11% of 351 patients treated with TRUSELTIQ, including patients with asymptomatic RPED, with a median onset of 26 days. Perform comprehensive ophthalmological exam including optical coherence tomography prior to initiating, at 1 month, at 3 months, and then every 3 months during treatment with TRUSELTIQ. Urgently evaluate patients for onset of visual symptoms and follow up every 3 weeks until resolved or TRUSELTIQ is discontinued. Withhold TRUSELTIQ as recommended. Dry eye occurred in 29% of 351 patients; treat with ocular demulcents as needed
  • Hyperphosphatemia and soft tissue mineralization: Hyperphosphatemia, which can lead to soft tissue mineralization, cutaneous calcinosis, non-uremic calciphylaxis, vascular calcification, and myocardial calcification, occurred in 82% of 351 patients treated with TRUSELTIQ, with a median time to onset of 8 days (range 1-349); 83% of 351 patients treated with TRUSELTIQ received phosphate binders. Monitor for hyperphosphatemia throughout treatment. Initiate phosphate-lowering therapy for serum phosphate >5.5 mg/dL; withhold TRUSELTIQ and initiate phosphate-lowering therapy for serum phosphate >7.5 mg/dL; withhold, reduce the dose, or permanently discontinue TRUSELTIQ based on duration and severity of hyperphosphatemia
  • Embryo-fetal toxicity: TRUSELTIQ can cause fetal harm. Advise pregnant women of the potential risk to the fetus; advise females of reproductive potential and men who are partnered with women of reproductive potential to use effective contraception during treatment with TRUSELTIQ and for 1 month after the final dose

Adverse reactions

  • Most common adverse reactions (incidence ≥20%, all grades): nail toxicity, stomatitis, dry eye, fatigue, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, constipation, abdominal pain, dry mouth, eyelash changes, diarrhea, dry skin, decreased appetite, blurred vision, and vomiting
  • Most common laboratory abnormalities (incidence ≥20%, all grades): increased creatinine, increased phosphate, decreased phosphate, increased alkaline phosphatase, decreased hemoglobin, increased alanine aminotransferase, increased lipase, increased calcium, decreased lymphocytes, decreased sodium, increased triglycerides, increased aspartate aminotransferase (AST), increased urate, decreased platelets, decreased leukocytes, decreased albumin, increased bilirubin, and decreased potassium

Drug interactions

  • CYP3A inhibitors: Avoid use with strong and moderate CYP3A inhibitors
  • CYP3A inducers: Avoid use with strong and moderate CYP3A inducers
  • Gastric acid–reducing agents: Avoid coadministration with proton pump inhibitors, histamine-2 receptor antagonists (H2RA), and locally acting antacids. If coadministration of H2RA or locally acting antacids cannot be avoided, separate TRUSELTIQ administration
    • H2RA: Take TRUSELTIQ 2 hours before or 10 hours after
    • Locally-acting antacid: Take TRUSELTIQ 2 hours before or 2 hours after

Dosage and administration

  • Prior to initiating TRUSELTIQ: Confirm FGFR2 fusion or rearrangement; perform comprehensive ophthalmic exam including OCT; confirm negative pregnancy test in females of reproductive potential
  • Starting dose: Take TRUSELTIQ orally once daily on Days 1-21 of 28-day cycles; continue treatment until disease progression or unacceptable toxicity. Take TRUSELTIQ on an empty stomach with a glass of water at least 1 hour before or 2 hours after food
    • No renal or hepatic impairment
      • 125 mg (one 100 mg capsule and one 25 mg capsule)
    • Mild and moderate renal impairment (creatinine clearance 30-89 mL/min)
      • 100 mg (one 100 mg capsule)
    • Mild hepatic impairment (total bilirubin >upper limit of normal [ULN] to 1.5 x ULN or AST > ULN)
      • 100 mg (one 100 mg capsule)
    • Moderate hepatic impairment (total bilirubin >1.5 to 3 x ULN with any AST)
      • 75 mg (three 25 mg capsules)
  • Dose modification: Consult the TRUSELTIQ full Prescribing Information for dose modifications and monitoring recommendations for RPED, hyperphosphatemia, and other Grades 3-4 adverse reactions

Please click here for full Prescribing Information.