Targeting FGFR

Genetic aberrations (eg, fusions/translocations, mutations, and amplifications) involving fibroblast growth factor receptors (FGFRs) are thought to drive disease in more than 100,000 new diagnoses each year in the United States.1,2

FGFR genetic aberrations (GAs) are present in 25% of cholangiocarcinomas.3 The most common FGFR GA is FGFR2 fusion, occurring in about 10%-16% of intrahepatic cholangiocarcinoma tumors.4 FGFR3 GAs are present in up to 20% of advanced urothelial carcinomas5 and cause more than 99% of achondroplasia cases.6

Our research supports the development of infigratinib,* an innovative investigational therapy that targets FGFR1-3 genetic alterations.7

  1. The safety and efficacy of infigratinib have not been established. There is no guarantee that infigratinib will receive health authority approval or become commercially available in any country for the uses being investigated.

Infigratinib*

Selective FGFR Inhibition

Infigratinib (BGJ398) is an investigational therapy and is not yet approved by any regulatory agencies.

It is an orally administered, ATP-competitive, FGFR1-3 tyrosine kinase inhibitor in development for the treatment of patients with FGFR-driven diseases, including cholangiocarcinoma (bile duct cancer), urothelial carcinoma (bladder cancer), and achondroplasia, a bone growth disorder in children.8-10 Infigratinib is not chemotherapy.

QED Therapeutics holds worldwide rights to infigratinib to evaluate its safety and efficacy for multiple FGFR-driven diseases.

Infigratinib clinical trials are currently enrolling, including the PROOF Trial for treatment of advanced/metastatic inoperable cholangiocarcinoma with FGFR2 fusions

For more information, see our pipeline or email medinfo@QEDTx.com.

Compassionate Use and Expanded Access

Currently, QED Therapeutics does not have a formal expanded access program in place and considers requests for expanded access only on a case-by-case basis. Inquiries regarding expanded access may be sent to QEDExpandedAccess@QEDTx.com. You can expect acknowledgment of your message within 5 business days.

Patients seeking to enroll in clinical studies should visit www.clinicaltrials.gov for information regarding ongoing studies and current study site locations.

  1. The safety and efficacy of infigratinib have not been established. There is no guarantee that infigratinib will receive health authority approval or become commercially available in any country for the uses being investigated.

ATP=adenosine triphosphate.

Infigratinib* Pipeline

  1. The safety and efficacy of infigratinib have not been established. There is no guarantee that infigratinib will receive health authority approval or become commercially available in any country for the uses being investigated.

Clinical Trials Currently Enrolling

The single-arm, open-label, Phase 2 trial for oral infigratinib in patients with advanced or metastatic CCA with FGFR2 gene fusions/translocations, or other FGFR genetic alterations, with radiologic progression following a gemcitabine + cisplatin regimen for advanced disease OR have been treated with a gemcitabine-containing regimen, but cannot tolerate cisplatin.


The PROOF Trial is evaluating oral infigratinib vs gemcitabine + cisplatin in first-line, FGFR2 fusion-positive CCA. Patients were randomized 2:1 to receive investigational, oral infigratinib 125 mg once daily for the first 3 weeks (21 days) OR gemcitabine with cisplatin on Days 1 and 8 of a 21-day cycle.


The PROOF 302 Trial is a multicenter, double-blind, randomized, placebo-controlled trial of infigratinib for the adjuvant treatment of subjects with invasive urothelial carcinoma with FGFR3 genomic alterations.

Subjects will be randomized in a 1:1 ratio to receive oral infigratinib administered once daily for the first 3 weeks (21 days) of a 28-day treatment cycle for a maximum of 52 weeks.


An observational research study designed to learn more about the overall health, growth, and possible medical complications in children with achondroplasia (a bone growth disorder). No medication will be administered; however, children successfully enrolled in PROPEL for 6 months or more may be eligible for subsequent treatment trials sponsored by QED Therapeutics.

  1. The safety and efficacy of infigratinib have not been established. There is no guarantee that infigratinib will receive health authority approval or become commercially available in any country for the uses being investigated.

CCA=cholangiocarcinoma.

References

  1. National Cancer Institute. https://www.cancer.gov/about-cancer/understanding/statistics. Updated April 27, 2018. Accessed January 7, 2020.
  2. Helsten T et al. Clin Cancer Res. 2016;22(1):259-267.
  3. Jain A et al. JCO Precis Oncol. doi:10.1200/PO.17.00080.
  4. Pellino A et al. Transl Gastroenterol Hepatol. 2018;3(7):1-15. doi:10.21037/tgh. 2018. 07.02.
  5. Knowles MA et al. Nat Rev Cancer. 2015;15(1):25-41.
  6. National Institutes of Health. https://ghr.nlm.nih.gov/gene/FGFR3. Published November 27, 2018. Accessed January 7, 2020.
  7. Javle M et al. Poster presented at: ESMO 2018 Congress; October 19-23, 2018; Munich, Germany.
  8. National Institutes of Health. https://clinicaltrials.gov/ct2/show/NCT02657486. Accessed January 7, 2020.
  1. National Institutes of Health. https://clinicaltrials.gov/ct2/show/NCT02150967. Accessed January 7, 2020.
  2. Komla-Ebri D et al. J Clin Invest. 2016;126(5):1871-1884.
  3. American Cancer Society. https://www.cancer.org/cancer/bile-duct-cancer/about/key-statistics.html. Accessed January 7, 2020.
  4. Dana-Farber Cancer Institute. https://www.dana-farber.org/biliary-cancer/about/. Accessed January 7, 2020.
  5. Sia D et al. Nat Commun. 2015;6:6087. doi: 10.1038/ncomms7087.
  6. Griffiths AJF et al. https://www.ncbi.nlm.nih.gov/books/NBK21766/. Accessed January 7, 2020.
  7. Moss TJ et al. Eur Urol. 2017;72(4):641-649.
  8. National Institutes of Health. https://ghr.nlm.nih.gov/condition/achondroplasia. Accessed January 7, 2020.
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