According to a story from gurufocus, the biotechnology company QED Therapeutics recently announced that the first patients have been dosed in separate phase 2 and phase 3 clinical studies testing the company’s leading product candidate infigratinib. The phase 3 trial will test the drug as a treatment for urothelial carcinoma following surgery. The phase 2 trial will test infigratinib for a wide variety of metastatic or advanced solid tumors that carry the relevant FGFR genetic changes that the drug is designed to act upon. QED Therapeutics was established with the specific focus of developing therapies for disease driven by FGFR.
Phase 3 Study Overview
As infigratinib is designed to act on FGFR mutations, only patients with these alterations will be selected for treatment in the trials; in the phase 3 trial, patients with invasive urothelial carcinoma that have FGFR3 mutations will be recruited. Historically, these patients are at a major risk of disease recurrence after surgical intervention to remove the tumor. Often, this occurs within two years following the operation. The primary endpoint for this study will be disease free survival; secondary endpoints include overall survival, safety and tolerability, and survival without metastasis.
Phase 2 Study Overview
The phase 2 trial is broader in scope. This open label study will include a wide variety of solid tumor cancers that carry the relevant gene changes. This will be an open label study with no placebo group; the primary endpoint in this trial will be the overall response rate to the treatment. Secondary endpoints include best overall response, survival without disease progression, overall survival, rate of disease control, and safety and tolerability measures.
In earlier studies, infigratinib has been able have a significant impact on tumors FGFR3 alterations and FGFR2 fusions, giving researchers hope that the experimental drug could have a similar effect on a wider array of FGFR alterations. The reality is that there are several different FGFR changes that can fuel the growth of a cancer tumor, and infigratinib has the potential to make a difference in all of them.