Phase II Study of Erdafitinib in Patients With Tumors With Fibroblast Growth Factor Receptor Mutations or Fusions: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol K2

Author:

Gong Jun1ORCID,Mita Alain C.1,Wei Zihan2ORCID,Cheng Heather H.3ORCID,Mitchell Edith P.4,Wright John J.5,Ivy S. Percy5ORCID,Wang Victoria2,Gray Robert C.2ORCID,McShane Lisa M.5ORCID,Rubinstein Larry V.5ORCID,Patton David R.5ORCID,Williams P. Mickey6ORCID,Hamilton Stanley R.7ORCID,Tricoli James V.5ORCID,Conley Barbara A.5ORCID,Arteaga Carlos L.8,Harris Lyndsay N.5ORCID,O'Dwyer Peter J.9,Chen Alice P.5ORCID,Flaherty Keith T.10ORCID

Affiliation:

1. Cedars-Sinai Medical Center, Los Angeles, CA

2. Dana Farber Cancer Institute—ECOG-ACRIN Biostatistics Center, Boston, MA

3. University of Washington, Seattle, WA

4. Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, PA

5. Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD

6. Frederick National Laboratory for Cancer Research, Bethesda, MD

7. City of Hope Comprehensive Cancer Center, Duarte, CA

8. UT Southwestern Simmons Comprehensive Cancer Center, Dallas, TX

9. University of Pennsylvania, Philadelphia, PA

10. Massachusetts General Hospital Cancer Center, Boston, MA

Abstract

PURPOSE Subprotocol K2 (EAY131-K2) of the NCI-MATCH platform trial was an open-label, single-arm, phase II study designed to evaluate the antitumor efficacy of the oral FGFR1-4 inhibitor, erdafitinib, in patients with tumors harboring FGFR1-4 mutations or fusions. METHODS Central confirmation of tumor FGFR1-4 mutations or fusions was required for outcome analysis. Patients with urothelial carcinoma were excluded. Enrolled subjects received oral erdafitinib at a starting dose of 8 mg daily continuously until intolerable toxicity or disease progression. The primary end point was objective response rate (ORR) with key secondary end points of safety, progression-free survival (PFS), and overall survival (OS). RESULTS Thirty-five patients were enrolled, and 25 patients were included in the primary efficacy analysis as prespecified in the protocol. The median age was 61 years, and 52% of subjects had received ≥3 previous lines of therapy. The confirmed ORR was 16% (4 of 25 [90% CI, 5.7 to 33.0], P = .034 against the null rate of 5%). An additional seven patients experienced stable disease as best-confirmed response. Four patients had a prolonged PFS including two with recurrent WHO grade IV, IDH1-/2-wildtype glioblastoma. The median PFS and OS were 3.6 months and 11.0 months, respectively. Erdafitinib was manageable with no new safety signals. CONCLUSION This study met its primary end point in patients with several pretreated solid tumor types harboring FGFR1-3 mutations or fusions. These findings support advancement of erdafitinib for patients with fibroblast growth factor receptor–altered tumors outside of currently approved indications in a potentially tumor-agnostic manner.

Publisher

American Society of Clinical Oncology (ASCO)

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