NEW YORK – QED Therapeutics, an affiliate of BridgeBio Pharma, said on Thursday that the first patients have been dosed in two separate clinical trials evaluating infigratinib (BGJ398) in cancer patients with FGFR alterations.
The Phase III PROOF 302 trial will study urothelial cancer patients with a targetable FGFR3 alteration, which is to be histologically or cytologically confirmed prior to enrollment. Participants are randomized to receive either infigratinib or placebo. The primary outcome will be progression-free survival and secondary outcomes include metastasis-free survival, overall survival, as well as safety and tolerability.
"Many patients with invasive urothelial carcinoma will have their cancer recur within two years after surgery," Sumanta Pal, lead investigator on the PROOF 302 trial said in a statement. "I believe there are many patients who could benefit from an oral, post-surgery treatment option that targets FGFR3 alterations, the genetic driver of many urothelial carcinomas."
The Phase II, single-arm study will evaluate the anti-tumor effects of infigratinibin patients with advanced or metastatic solid tumors who are positive for FGFR1-3 gene fusions/translocations or other FGFR alterations. The primary outcome will be overall response rate, and secondary outcomes include progression-free survival, best overall response, disease control rate, overall survival, and safety and tolerability.
Prior to enrollment, patients must have FGFR gene fusions/translocations or activating mutations determined by a local or central CLIA-certified lab.
"Given the activity we have seen with infigratinib in FGFR2-fusion-driven bile duct cancers and FGFR3-altered urothelial carcinoma, our hope is that infigratinib will demonstrate similar activity in additional cancers that appear to be driven by alterations in FGFR," Sameek Roychowdhury, lead investigator of the Phase II study, said in a statement."There appear to be multiple FGFR alterations that can drive cancer growth—and we hope to see these patients benefit too."
In other ongoing studies, FGFR fusions have shown potential for being a pan-cancer biomarker. In January, the US Food and Drug Administration granted fast track designation to infigratinib for first-line treatment of advanced or metastatic bile duct cancer with FGFR2 gene fusions or translocations.
Janssen, Incyte, and Taiho Oncology all have FGFR inhibitors in development.