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Thomas Flaig, MD


Evaluating Adjuvant Infigratinib in Bladder Cancer With FGFR3 Alterations

By: Vanessa A. Carter, BS
Posted: Thursday, March 31, 2022

The randomized phase III PROOF 302 study aims to investigate the safety and efficacy of adjuvant infigratinib—an ATP-competitive FGFR1–3 selective oral tyrosine kinase inhibitor—in patients with high-risk, muscle-invasive urothelial carcinoma. The early design of this trial was presented by Suzanne Cole, MD, FACP, of The University of Texas Southwestern Medical Center, Dallas, and colleagues during the 2022 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (Abstract TPS580).

“Even when surgery is combined with cisplatin-based (neo)adjuvant chemotherapy, recurrence rates are high,” mentioned the investigators. “FGFR3 genetic alterations occur in 21% to 38% of muscle-invasive upper tract urothelial cancer, and in approximately 20% of invasive urothelial bladder cancer, [and] infigratinib has clinical activity and tolerability in patients with advanced/metastatic urothelial carcinoma harboring [these] alterations.”

This global, multicenter, double-blind trial plans to enroll eligible patients with high-risk, muscle-invasive upper tract urothelial carcinoma (85%) or urothelial bladder cancer (15%) with susceptible FGFR3 aberrations following surgical intervention. The protocol was amended to include individuals with carcinoma in situ at surgical margins, as well as those who could not receive cisplatin-based chemotherapy.

Patients are required to have no metastases and to have either stage ypT2 and/or yN-positive or pT2 pN0 to 2 or pN-positive disease after neoadjuvant chemotherapy or stage pT3 or pN-positive status without neoadjuvant chemotherapy. Participants will be randomly assigned to receive 125 mg of oral infigratinib or placebo on days 1 to 21 of a 28-day cycle for up to 52 weeks or until recurrence, unacceptable toxicity, or death.

The primary endpoint of this trial is centrally reviewed disease-free survival, and secondary endpoints include overall survival, safety and tolerability, and metastasis-free survival. Other exploratory endpoints consist of pharmacokinetics, quality of life, proteomic and genomic assessment of tumor tissue and DNA samples from baseline to recurrence, and the correlation of genomic alterations to features of urothelial carcinoma.

Disclosure: For full disclosures of the study authors, visit

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