FibroGen Reports Data From Fortis Therapeutics-Sponsored Phase 1 Study Of FG-3246
FibroGen Reports Data From Fortis Therapeutics-Sponsored Phase 1 Study Of FG-3246
FibroGen 報告了富通療法贊助的 FG-3246 1 期研究的數據
In the efficacy analysis, PSA reductions of ≥ 50% were observed in 36% of PSA evaluable patients. For RECIST evaluable patients, 20% met the criteria of a partial response, or tumor reduction in size of ≥ 30%, with a median duration of response of 7.5 months. The median rPFS in this heavily pre-treated patient population was 8.7 months. Company plans to meet with the U.S. Food and Drug Administration (FDA) to discuss development pathway; Phase 2 initiation is anticipated in 2H 2024
在療效分析中，在36％的PSA可評估患者中，觀察到PSA降低了≥50％。對於RECIST可評估的患者，有20％符合部分緩解或腫瘤大小縮小≥30％的標準，中位緩解持續時間爲7.5個月。在這個經過大量預治療的患者群體中，RPF的中位數爲8.7個月。公司計劃與美國食品藥品監督管理局（FDA）會面，討論開發路徑；第二階段預計將於2024年下半年啓動
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