Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial

Pal, Sumanta; Somford, Diederik M.; Grivas, Petros; Sridhar, Srikala S.; Gupta, Shilpa; Bellmunt Molins, Joaquim, 1959-; Sonpavde, Guru; Fleming, Mark T.; Lerner, Seth Paul; Loriot, Yohann; Hoffman-Censits, Jean; Valderrama, Begoña P.; Andresen, Corina; Schnabel, Marco J.; Cole, Suzanne; Daneshmand, Siamak

doi:http://dx.doi.org/10.2217/fon-2021-1629

Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial

Citation

Pal SK, Somford DM, Grivas P, Sridhar SS, Gupta S, Bellmunt J, et al. Targeting FGFR3 alterations with adjuvant infigratinib in invasive urothelial carcinoma: the phase III PROOF 302 trial. Future Oncol. 2022 Jul; 18(21): 2599-614. DOI: 10.2217/fon-2021-1629

Abstract

PROOF 302 is an ongoing randomized, double-blind, placebo-controlled, adjuvant phase III trial (NCT04197986) in approximately 218 patients from 120 centers worldwide. Eligibility criteria include post-surgical high-risk muscle-invasive upper tract urothelial cancer (85% of patients) or urothelial bladder cancer (15%), susceptible FGFR3 alterations (activating mutations, gene fusions or rearrangements), ≤120 days following radical surgery and ineligible for/or refusing cisplatin-based (neo)adjuvant chemotherapy. Patients receive either oral infigratinib 125 mg or placebo daily on days 1-21 of a 28-day cycle for up to 52 weeks or until recurrence, unacceptable toxicity or death. Primary end point: centrally determined disease-free survival (DFS); secondary end points: investigator-assessed DFS, metastasis-free survival, overall survival and safety/tolerability; exploratory end points: correlative biomarker analysis, quality-of-life and infigratinib pharmacokinetics.