Abstract Details

Title Pemigatinib For Previously Treated Central Nervous System Tumors With Activating FGFR Mutations or Translocations: Results From FIGHT-207

Topic Neuro-oncology

Presentation(s) S17 - Innovations in Neuro-oncology (1:36 PM-1:48 PM)

Poster/Presentation
Number 004

Background Dysregulated fibroblast growth factor receptor (FGFR) signaling impacts glioma progression. Pemigatinib is a potent, selective FGFR1–3 inhibitor with antitumor activity in solid tumors. The open-label, single-arm phase 2 FIGHT-207 study evaluated pemigatinib in previously treated advanced/metastatic or surgically unresectable solid tumors with activating FGFR mutations/translocations, including CNS tumors (NCT03822117).

Objective To report the activity of pemigatinib in the subset of FIGHT-207 patients with previously treated CNS tumors.

Design/Methods Eligible patients were adults with advanced/metastatic or surgically unresectable solid tumors that progressed after ≥1 prior therapy. Patients were assigned into cohorts based on confirmed FGFR status (FGFR1–3 fusions/rearrangements, mutations, and other molecular alterations). Patients received 13.5 mg pemigatinib QD (continuous dosing) until disease progression or unacceptable toxicity. Primary endpoints were objective response rates per RECIST v1.1 or RANO assessed by independent central review. Secondary endpoints included the rate of treatment-emergent adverse events (TEAEs).

Results

CNS tumors were GBM (n=9), low-grade pediatric-type glioma (n=1), grade II infiltrating glioma (n=1), grade II diffuse astrocytoma (n=1), and polymorphous low-grade neuroepithelial tumor of the young (n=1). FGFR alterations were FGFR3-TACC3 fusions (n=9 [2 unconfirmed], 69.2%), FGFR1 K656E mutations (n=2, 15.4%), unconfirmed FGFR1 N546K mutation (n=1, 7.7%), and FGFR1-MITF fusion (n=1, 7.7%). Ten (76.9%) patients each received previous radiation and surgery; 11 (84.6%) received prior systemic therapy. One (FGFR3-TACC3 fusion) and 2 patients (FGFR3-TACC3 fusion, n=1; FGFR1 K656E, n=1) achieved complete and partial responses, respectively. Stable and progressive disease was observed in 3 (FGFR3-TACC3 fusion, n=2; FGFR1 N546K, n=1) and 6 patients (FGFR3-TACC3 fusion, n=4; FGFR1 NK656E, n=1; FGFR1-MITF fusion, n=1), respectively; 1 patient was not evaluable. TEAE incidence was similar to the previously reported safety profile.

Conclusions Pemigatinib showed promising activity in patients with CNS tumors with activating FGFR1–3 fusions/rearrangements; no new TEAEs were observed. The ongoing FIGHT-209 study will provide additional data in this population.

Authors/Disclosures
Iben Spanggaard, MD, PhD (The Phase 1 Unit, Dept. of Oncology, Rigshospitalet - Copenhagen University Hosp) PRESENTER	Dr. Spanggaard has received personal compensation in the range of $500-$4,999 for serving as a Consultant for AstraZeneca. The institution of Dr. Spanggaard has received research support from Roche. The institution of Dr. Spanggaard has received research support from Genentech. The institution of Dr. Spanggaard has received research support from Astra-Zeneca. The institution of Dr. Spanggaard has received research support from Incyte. The institution of Dr. Spanggaard has received research support from Pfizer. The institution of Dr. Spanggaard has received research support from MSD. The institution of Dr. Spanggaard has received research support from PUMA Biotechnology. The institution of Dr. Spanggaard has received research support from Orion Pharma. Dr. Spanggaard has received personal compensation in the range of $500-$4,999 for serving as a Reimbursement for travel-related expenses for the AAN2023 with Incyte.
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Santosh Kesari, MD, PhD, FAAN (Saint John's Cancer Institute)	Dr. Kesari has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for xcures. Dr. Kesari has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Duke.