Hackensack University Medical Center Investigates Safety and Efficacy of Promising Precision Therapy in FIGHT-101 Trial

Marks First In-Human Study of FGFR 1-3 Inhibitor Pemigatinib

Hackensack University Medical Center researchers helped vet the safety and efficacy of pemigatinib, a new precision therapy. The key findings, published in the Annals of Oncology, include:

• Pemigatinib was found safe and demonstrated pharmacodynamic and clinical activity, with responses seen across tumors and driven by FGFR fusions/rearrangements and mutations.
• The treatment was active across a broad spectrum of tumors, most commonly in cholangiocarcinoma.
• Pemigatinib may potentially offer benefits in other cancers with FGFR rearrangements and/or mutations.

The phase I/II FIGHT-101 study evaluated safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of pemigatinib, a potent and selective fibroblast growth factor receptor (FGFR) 1-3 inhibitor, as monotherapy or in combination therapy, for refractory advanced malignancies, with and without fibroblast growth factor (FGF) and receptor (FGFR) gene alterations.

The study outcomes supported those of FIGHT-202 that led to pemigatinib approval for advanced FGFR2-rearranged cholangiocarcinoma. The Phase I/II study’s results led to a registrational study in cholangiocarcinoma and phase II/III trials in multiple tumor types validating the benefit of precision therapy.

Learn more about innovative cancer treatments at Hackensack University Medical Center.