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

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.