Fibroblast growth factor receptor (FGFR) inhibitor rogaratinib in patients with advanced pretreated squamous-cell non-small cell lung cancer over-expressing FGFR mRNA: The SAKK 19/18 phase II study.

e21119 Background: A substantial proportion of patients with squamous lung cell carcinoma (SQCLC) (46%) exhibit tumor overexpression fibroblast growth factor receptor (FGFR) messenger ribonucleic acid (mRNA). Rogaratinib is a novel pan-FGFR inhibitor anti-tumor activity in pre-clinical models as single agent FGFR pathway-addicted models. Phase I data showed promising and good safety profile. The objective the SAKK 19-18 trial was to determine clinical rogaratinib advanced SQCLC overexpressing FGFR1-3 mRNA. Methods: Patients metastatic SQCLC, previously treated systemic treatment, tumour mRNA were 600 mg BID until progression disease or drug intolerance. rate ≤15% PFS at 6 months considered uninteresting, whereas ≥38% promising. Ten needed first stage least 2 achieving order continue accrual. Results: Between May November 2020, 49 screened 20 classified positive. Among them15 registered 10 assessed for analysis. Most commons treatment related adverse events (TRAEs) hyperphosphatemia (60%), diarrhoea (20%), dry mouth (20%). Grade ≥3 TRAEs occurred 50% patents Hypercalcemia being most frequent one only 1 achieved while boundary required continuing this trial. Conclusions: Despite preliminary signal activity, failed improve Further studies on more reliable biomarker are needed, development has been put hold by Bayer 19/18 study terminated early due lack efficacy. Clinical information: NCT03762122.