NEW YORK – Switzerland-based Basilea Pharmaceutica on Wednesday announced that it has partnered with Eli Lilly to evaluate its FGFR inhibitor derazantinib with Lilly's anti-VEGFR2 antibody ramucirumab (Cyramza) as a treatment for patients with FGFR-altered, advanced gastric cancer.
The multi-cohort, Phase I/II trial, dubbed FIDES-03, will explore the safety and efficacy of derazantinib as a monotherapy, derazantinib with ramucirumab and chemotherapy, and derazantinib plus the checkpoint inhibitor atezolizumab (Roche's Tecentriq). Under the terms of the collaboration, Lilly will supply Basilea with ramucirumab and collaborate on clinical aspects of the trial, while Basilea will remain the trial's sponsor.
Ramucirumab is approved by the US Food and Drug Administration as a second-line treatment alone or in combination with chemotherapy for patients with advanced gastric cancer and is considered the standard of care in this setting.
Because derazantinib is designed to inhibit CSF1R and VEGFR2, in addition to the FGFR1, FGFR2, and FDGFR3 kinases, Basilea believes that combining the agent with Lilly's anti-VEGFR2 drug may further benefit this biomarker-defined patient population. "[Derazantinib's] unique kinase inhibition profile may complement the anti-angiogenic effects of ramucirumab in the treatment of patients with advanced gastric cancer," Basilea Chief Medical Officer Marc Engelhardt said in a statement. "Exploring combination therapies in order to strengthen the clinical evidence on the differentiation of derazantinib versus other FGFR inhibitors is one important element of our development strategy for the compound."
In addition to the FIDES-03 gastric cancer trial, Basilea is investigating derazantinib's activity in other cancer indications.
FIDES-01 is a Phase II registrational study assessing derazantinib as a treatment for patients with inoperable or advanced intrahepatic cholangiocarcinoma whose tumors harbor FGFR2 gene fusions or FGFR2 amplifications or mutations. And in the tumor-agnostic Phase I/II study, Basilea is evaluating derazantinib for patients with metastatic solid tumors with FGFR genetic alterations. Earlier this month, Basilea pooled the data on cholangiocarcinoma patients in these two studies and reported on derazantinib's efficacy.
In another trial, FIDES-02, Basilea is evaluating derazantinib both alone and in combination with atezolizumab as a treatment for patients with advanced urothelial carcinoma characterized by FGFR gene aberrations.