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BridgeBio Pharma’s QED Therapeutics Announces Dosing of First Patients in Phase 3 and Phase 2 Clinical Trials of Infigratinib in Tumors with FGFR Genetic Alterations
PROOF 302 Trial Enrolling Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations Ohio State University-Led Trial to Study
About this update from Bridgebio Pharma, Inc.
[{"type":"text","content":"PROOF 302 Trial Enrolling Subjects with Invasive Urothelial Carcinoma with Susceptible FGFR3 Genetic Alterations\n Ohio State University-Led Trial to Study Infigratinib for Treatment of Patients with Advanced or Metastatic Solid Tumors with FGFR Genetic Alterations SAN FRANCISCO, March 12, 2020 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO) affiliate company QED Therapeutics announced today that patients have been dosed in separate Phase 3 and Phase 2 clinical trials of infigratinib in cancer indications. The Phase 3 PROOF 302 trial sponsored by QED is studying infigratinib for the adjuvant (post-surgery) treatment of invasive urothelial carcinoma. A second, investigator-initiated trial, led by Sameek Roychowdhury, M.D., Ph.D., of The Ohio State University (OSU) Comprehensive Cancer Center, is studying infigratinib for the treatment of advanced and metastatic solid tumors with confirmed FGFR gene fusions/translocations or other FGFR alterations. In the PROOF 302 trial, investigators are enrolling subjects with invasive urothelial cancer harboring susceptible FGFR3 genetic alterations who are at high risk of recurrence following surgical resection. Subjects will be randomized (1:1) to receive once daily oral infigratinib or placebo. The primary outcome is disease-free survival, and secondary outcomes include metastasis-free survival, overall survival, and safety and tolerability measures. “Many patients with invasive urothelial carcinoma will have their cancer recur within two years after surgery,” said PROOF 302 trial lead Sumanta Pal, M.D., professor of medical oncology and therapeutics research at City of Hope Comprehensive Cancer Center. “Correspondingly, 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 2 study at OSU and selected sites within the Oncology Research Information Exchange Network (ORIEN) will evaluate the efficacy of infigratinib in patients who have advanced or metastatic solid tumors that are positive for FGFR1-3 gene fusions/translocations or other FGFR alterations. The open-label study will assess overall response rate as the primary outcome. Secondary outcomes include progression-free survival, best overall response, disease control rate, overall survival and...