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Hussein Sweiti



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    P86 - Targeted Therapy - Clinically Focused - New Target (ID 263)

    • Event: WCLC 2020
    • Type: Posters
    • Track: Targeted Therapy - Clinically Focused
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      P86.03 - A Phase 2 Study of Erdafitinib in Patients with Advanced Solid Tumors and Fibroblast Growth Factor Receptor Gene Alterations (ID 1509)

      00:00 - 00:00  |  Presenting Author(s): Hussein Sweiti

      • Abstract
      • Slides

      Introduction

      Erdafitinib is the first pan-FGFR tyrosine kinase inhibitor approved by the US Food and Drug Administration (FDA) for locally advanced or metastatic urothelial carcinoma in adult patients with susceptible FGFR3/2 genetic alterations and who have progressed during or following ≥1 line of prior platinum-containing chemotherapy (PCC), including within 12 months of neoadjuvant or adjuvant PCC. FGFR gene alterations are potential oncogenic drivers and have been reported in many adult and pediatric solid tumors. Patients with metastatic solid tumors who have failed ≥1 line of systemic therapy have a dismal prognosis and show limited response to standard of care options. Therefore, there is a strong rationale to assess the safety and efficacy of erdafitinib in adolescent and adult patients with FGFR-altered advanced solid tumors.

      Abstract submitted to the European Society for Medical Oncology (ESMO) Annual Meeting 2020 (awaiting outcome notification).

      Methods

      This phase 2, open-label study (NCT04083976) will include patients ≥12 years of age with histologically confirmed unresectable, locally advanced, or metastatic solid tumor malignancy (except urothelial tumors) harboring pre-defined FGFR mutations or fusions. Eligibility screening includes molecular screening for FGFR alterations by central or local next-generation sequencing assays, and other clinical criteria. Patients will enroll into (1) broad panel cohort (BPC) of target FGFR alterations, or (2) exploratory cohort (EC) for FGFR alterations which do not meet criteria for BPC. Approximately 280 patients (BPC, n=240; EC, n=40) will be enrolled. The primary efficacy endpoint is overall response rate (ORR) as assessed by the Independent Review Committee. Secondary endpoints include investigator-assessed ORR, duration of response, disease control rate, progression-free survival, overall survival, pharmacokinetics, and health-related quality of life. Safety assessments include adverse events, vital signs, electrocardiograms, physical examinations, laboratory tests, performance status assessment, growth assessments in adolescents and ophthalmologic examination.

      Results

      Starting December 2019, patients will be enrolled at ~158 sites in 15 countries.

      Conclusion

      Results of this study may provide efficacy and safety data for erdafitinib across multiple FGFR-altered solid tumors and evaluate the potential benefit of targeting the underlying altered biology of FGFR irrespective of tumor histology in adult and adolescent patients.

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