Basilea reports data from poster presentations at ESMO Virtual Congress 2020

• Gene expression data may explain differences in clinical adverse event profiles of FGFR inhibitors
• Antitumor activity of derazantinib in preclinical cancer models with FGFR aberrations supports planned gastric cancer study
• Full results from the completed phase 1 study in patients with brain cancer underscores the potential for lisavanbulin to be developed in a targeted patient population using end-binding protein 1 (EB1) as a patient selection criterion
  
  

Basel, Switzerland, September 22, 2020

Basilea Pharmaceutica Ltd. (SIX: BSLN) today reports on several e-posters with new preclinical and clinical data on its fibroblast growth factor receptor (FGFR) inhibitor derazantinib and its tumor checkpoint controller, lisavanbulin, presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, which took place from 19-21 September, 2020.

A preclinical study showed that treatment-specific gene expression patterns in tumor models may help elucidating the biological processes driving differences in the clinical adverse event profiles of FGFR inhibitors. Moreover, the results from this study may explain low rates of adverse events reported with derazantinib for retinal events, mucositis and nail toxicities.

Results from a series of preclinical efficacy models of breast, colorectal, head & neck, lung, ovarian and gastric cancer with confirmed FGFR1-3 genetic aberrations, showed that FGFR2-fusion-positive gastric cancer models were particularly sensitive to treatment with derazantinib. In addition, gastric and lung cancer models showed the strongest correlation of FGFR1-3 expression versus the anticancer activity of derazantinib. The results support the planned clinical investigation of derazantinib in gastric cancer as its next indication.

Full results from a phase 1 study with once-daily oral lisavanbulin in adult patients with recurrent glioblastoma (GBM), or high-grade glioma, showed an overall clinical benefit rate of 44% at six months at daily doses of 25-30 mg. There was an exceptional long-lasting response in a patient, whose tumor tissue was positive for end-binding protein 1 (EB1), a previously identified response predictive biomarker for lisavanbulin in preclinical studies. A phase 2 expansion study will be initiated shortly, which will use EB1-positivity as a patient selection criterion.¹ Lisavanbulin is dosed at the recommended phase 2 dose of 25 mg/day in this phase 2 study in patients with recurrent GBM. The prevalence of EB1-positivity in GBM is estimated at 2-5%.