FIND: a phase-II study to evaluate the efficacy and safety of erdafitinib in FGFR-altered NSCLC

Abstract Introduction: FGFR alterations occur in approximately 2% of non-small cell lung cancer (NSCLC) patients, predominantly in squamous cell histology (sqNSCLC). We evaluated the efficacy of the selective FGFR1-4 inhibitor erdafitinib in patients with FGFR-altered NSCLC. Methods: NSCLC patients were screened within the national Network Genomic Medicine for FGFR mutations/fusions. Patients were treated with erdafitinib in 3 cohorts: High confidence activating FGFR fusions (1), high confidence activating FGFR mutations (2), and low confidence activating FGFR alterations (3). The primary objective was the best confirmed overall response rate (ORR) in cohorts 1 and 2. Statistics analysis was based on Simon’s two-stage design. Results: Between 7/2019 and 9/2022, 44.537 pts were screened in nNGM, 26 pts were enrolled in stage I of Simon’s design, and 4 pts failed screening. Most pts were male (77%) and had sqNSCLC (73%). All pts were current or previous smokers. Of 22 patients on erdafitinib, 7 were treated in cohort 1, 8 in cohort 2, and 7 in cohort 3. In cohort 1, two of 7 patients achieved partial response (PR). One PR remained unconfirmed. The best response in cohort 2 was stable disease. Any grades most observed adverse events were hyperphosphatemia in 45.5%, diarrhea, and dry mouth – both in 31.8% of patients. Conclusion: According to the first stage of the two-stage Simon’s design, erdafitinib showed preliminary efficacy in NSCLC with FGFR fusions. Further molecular and clinical data are needed to evaluate the efficacy of FGFR inhibition in NSCLC, especially in patients with FGFR mutations.

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Journal
Clinical Cancer Research
Published
2026-10-08
DOI
https://doi.org/10.1158/1078-0432.ccr-26-1485
Primary Topic
Lung Cancer Treatments and Mutations
Type
article
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article

FIND: a phase-II study to evaluate the efficacy and safety of erdafitinib in FGFR-altered NSCLC

Martin Sebastian, Theresa Reutter, Reinhard Büttner, Andreas Hans Scheel et al.
Clinical Cancer Research
Lung Cancer Treatments and Mutations
article

FIND: a phase-II study to evaluate the efficacy and safety of erdafitinib in FGFR-altered NSCLC

Martin Sebastian, Theresa Reutter, Reinhard Büttner, Andreas Hans Scheel, Anna Eisert, Heather Scharpenseel, Thorsten Persigehl, Jens Panse, Rieke Nila Fischer, Martin Wermke, Sebastian Yves Friedrich Michels, Martin Hellmich, Axel M. Hillmer, Matthias Scheffler, Frank Griesinger, Anna Kron, Richard F. Riedel, Lucia Nogová, Roman Kurt Thomas, Jens Kern, Florian Malchers, Andreas Draube, Julia Frank, Niels Reinmuth, Sabine Merkelbach‐Bruse, Horst-Dieter Hummel, Inken Terjung, Anna Rasokat, Janna Siemanowski-Hrach, Jürgen Wolf, M. Brodersen, Petra Heiden, Christian Grohé, Gregor Zadoyan
article en

Abstract

Abstract Introduction: FGFR alterations occur in approximately 2% of non-small cell lung cancer (NSCLC) patients, predominantly in squamous cell histology (sqNSCLC). We evaluated the efficacy of the selective FGFR1-4 inhibitor erdafitinib in patients with FGFR-altered NSCLC. Methods: NSCLC patients were screened within the national Network Genomic Medicine for FGFR mutations/fusions. Patients were treated with erdafitinib in 3 cohorts: High confidence activating FGFR fusions (1), high confidence activating FGFR mutations (2), and low confidence activating FGFR alterations (3). The primary objective was the best confirmed overall response rate (ORR) in cohorts 1 and 2. Statistics analysis was based on Simon’s two-stage design. Results: Between 7/2019 and 9/2022, 44.537 pts were screened in nNGM, 26 pts were enrolled in stage I of Simon’s design, and 4 pts failed screening. Most pts were male (77%) and had sqNSCLC (73%). All pts were current or previous smokers. Of 22 patients on erdafitinib, 7 were treated in cohort 1, 8 in cohort 2, and 7 in cohort 3. In cohort 1, two of 7 patients achieved partial response (PR). One PR remained unconfirmed. The best response in cohort 2 was stable disease. Any grades most observed adverse events were hyperphosphatemia in 45.5%, diarrhea, and dry mouth – both in 31.8% of patients. Conclusion: According to the first stage of the two-stage Simon’s design, erdafitinib showed preliminary efficacy in NSCLC with FGFR fusions. Further molecular and clinical data are needed to evaluate the efficacy of FGFR inhibition in NSCLC, especially in patients with FGFR mutations.

Clinical Cancer Research
TH Köln - University of Applied Sciences (DE), Carl von Ossietzky Universität Oldenburg (DE), University of Applied Sciences Mainz (DE), University of Cologne (DE), Johannes Gutenberg University Mainz (DE), University of Würzburg (DE), Asklepios Klinik Altona (DE), Universitäts-Kinderklinik Würzburg (DE), Medical Mission Institute (DE), Universitätsmedizin Göttingen (DE), Asklepios Fachkliniken München-Gauting (DE), Universitätsklinikum Würzburg (DE), University Hospital Cologne (DE), Helios Hospital Berlin-Buch (DE), Federal Highway and Transport Research Institute (DE), Technische Universität Dresden (DE), RWTH Aachen University (DE)
Openalex Percentile: Top 12%
Lung Cancer Treatments and Mutations
DOISourceOpenAlex
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