On 12 April 2019, the Food and Drug Administration (FDA) allowed the marketing of erdafitinib in urinary tract cancer treatment. This decision confirms the great potential of FGFR inhibitors in various solid cancers with FGFR aberrations and proves the recognition of this class medicines as new tools in advanced solid cancers treatment. Celon Pharma S.A. is currently conducting a phase I study for the FGFR inhibitor regarding the following cancers: bladder cancer, stomach cancer and squamous cell lung cancer.
BELVERSA (erdafitinib) has been approved by the FDA on the basis of a relatively small II phase programme, with a single non-randomised arm including 87 patients. Available data proves that patients’ response to the FGFR inhibitor amounted to 32.3%. Those patients did not respond to the earlier treatment which included cisplatin and immunotherapy based on antibodies anti-PDL-1 and PD1).
Celon Pharma S.A. is currently conducting a phase I study for the FGFR inhibitor (CPL304110) developed in regards to solid tumours with FGFR aberrations, including around 40 patients with bladder, stomach and squamous cell lung cancers. The end of phase I of the clinical trial is expected in 2020. Depending on the effect of the extended phase I clinical programme, Celon Pharma plans to immediately begin the second clinical phase in the selected indications, which in the case of an endpoint, in the form of the objective response rate, should last several months.
The Celon Pharma FGFR inhibitor development programme – CPL304110 – is based on the use of extended diagnostic tests which will allow us to additionally benefit in terms of selection of patients who might benefit clinically. The Company also sees the drug development potential, both in monotherapy and in connection with immunotherapy.
Phase I and II trials are realised within the CELONKO project "Development of modern biomarkers and development of an innovative FGFR kinases inhibitor" co-financed by The National Centre for Research and Development within STRATEGMED II programme. The amount of the co-financing is PLN 38,613,623