FibroGen Inc (NASDAQ:FGEN) announced topline data from the Fortis Therapeutics-sponsored Phase 1 study of FG-3246 (also known as FOR46), a potential first-in-class anti-CD46 antibody drug conjugate (ADC) with an MMAE-containing payload.
In a dose-escalation and dose-expansion trial, the study enrolled patients with metastatic castration-resistant prostate cancer whose tumors have progressed on at least one androgen receptor-signaling inhibitor.
In the efficacy analysis, prostate-specific antigens (PSA) reductions of over 50% were observed in 36% of PSA evaluable patients.
20% met the criteria of a partial response, or tumor reduction in size of over 30%, with a median duration of response of 7.5 months. The median radiographic progression-free survival (rPFS) in this heavily pretreated patient population ...