FibroGen to meet FDA on Phase 1 prostate cancer with adverse events

 

• FG-3246 demonstrated efficacy in adenocarcinoma selected cohorts receiving biologically active doses of FG-3246 at ≥ 1.2 mg/kg in heavily pre-treated, biomarker unselected patients:

• Median radiographic progression free survival of 8.7 months

• PSA50 response in 36% of patients

• Confirmed radiographic objective response rate of 20%, with a median duration of response of 7.5 months
  

• FG-3246 demonstrated an acceptable safety profile; adverse events consistent with those observed in other antibody drug conjugate therapies with a MMAE payload

• 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

https://www.globenewswire.com/news-release/2024/04/02/2856521/33525/en/FibroGen-Announces-Topline-Results-from-Phase-1-Monotherapy-Study-of-FG-3246-in-Patients-with-Metastatic-Castration-Resistant-Prostate-Cancer.html