Reference Detail

Contact

Missing content? – Request curation!

Request curation for specific Genes, variants, or PubMed publications.

Have questions, comments or suggestions? - Let us know!

Email us at : ckbsupport@jax.org

Ref Type Abstract
PMID
Authors Alfredo Addeo, Markus Joerger, Sacha Rothschild, Eric I. Eboulet, Gilles Godar, Christine Waibel-Pachinger, Simon Haefliger, Michael Thomas Mark, Eugenio Fernandez, Nicolas Mach, Laetitia A. Mauti, Martin Frueh
Title 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.
Journal Journal of Clinical Oncology
Vol 39
Issue 15_suppl
Date May 20, 2021
URL https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.e21119
Abstract Text e21119. Background: A substantial proportion of patients with squamous lung cell carcinoma (SQCLC) (46%) exhibit tumor overexpression of fibroblast growth factor receptor (FGFR) messenger ribonucleic acid (mRNA). Rogaratinib is a novel pan-FGFR inhibitor with anti-tumor activity in pre-clinical models as a single agent in FGFR pathway-addicted tumor models. Phase I data showed promising activity and good safety profile. The objective of the SAKK 19-18 trial was to determine clinical activity and safety of rogaratinib in patients with advanced SQCLC overexpressing tumor FGFR1-3 mRNA. Methods: Patients with metastatic SQCLC, previously treated with systemic treatment, overexpressing tumour FGFR mRNA were treated with rogaratinib 600 mg BID until progression of disease or drug intolerance. A rate ≤15% of PFS at 6 months was considered uninteresting, whereas a PFS rate at 6 months ≥38% was considered promising. Ten patients were needed in the first stage with at least 2 achieving 6 months PFS in order to continue the accrual. Results: Between May and November 2020, 49 patients were screened and 20 were classified FGFR positive. Among them15 patients were registered in the trial and the first 10 were assessed for the first stage analysis. Most commons treatment related adverse events (TRAEs) were hyperphosphatemia (60%), diarrhoea (20%), and dry mouth (20%). Grade ≥3 TRAEs occurred in 50% of the patents with Hypercalcemia being the most frequent one (20%). Among 10 first patients only 1 achieved 6 months PFS while 2 was the boundary required for continuing this trial. Conclusions: Despite preliminary signal of activity, rogaratinib failed to improve PFS in patients overexpressing tumor FGFR mRNA. Further studies on a more reliable biomarker are needed, the development of rogaratinib in SQCLC has been put on hold by Bayer and the SAKK 19/18 study was terminated early due to lack of efficacy. Clinical trial information: NCT03762122.

Filtering

  • Case insensitive filtering will display rows where any text in any cell matches the filter term
  • Simple literal full or partial string matches
  • Separate multiple filter terms with a spaces, order doesn't matter (a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page, filtering has no impact on query parameters
  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

Sorting

  • Generally, the default sort order for tables is set to be first column ascending, however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column, be sure to set ascending or descending order for a given column, before moving on to the next column.

Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FGFR3 over exp lung squamous cell carcinoma no benefit Rogaratinib Phase II Actionable In a Phase II trial, Rogaratinib (BAY 1163877) treatment did not result in improved progression-free survival (PFS) of metastatic lung squamous cell carcinoma patients with overexpression of FGFR1, FGFR2, or FGFR3, as only 10% (1/10) of patients achieved 6-month PFS, further clinical development of this agent was halted (J Clin Oncol 39, no. 15_suppl (May 20, 2021) e2119; NCT03762122). detail...
FGFR1 over exp lung squamous cell carcinoma no benefit Rogaratinib Phase II Actionable In a Phase II trial, Rogaratinib (BAY 1163877) treatment did not result in improved progression-free survival (PFS) of metastatic lung squamous cell carcinoma patients with overexpression of FGFR1, FGFR2, or FGFR3, as only 10% (1/10) of patients achieved 6-month PFS, further clinical development of this agent was halted (J Clin Oncol 39, no. 15_suppl (May 20, 2021) e2119; NCT03762122). detail...
FGFR2 over exp lung squamous cell carcinoma no benefit Rogaratinib Phase II Actionable In a Phase II trial, Rogaratinib (BAY 1163877) treatment did not result in improved progression-free survival (PFS) of metastatic lung squamous cell carcinoma patients with overexpression of FGFR1, FGFR2, or FGFR3, as only 10% (1/10) of patients achieved 6-month PFS, further clinical development of this agent was halted (J Clin Oncol 39, no. 15_suppl (May 20, 2021) e2119; NCT03762122). detail...