Shore N, et al. - The intent of the authors was to ascertain if fexapotide triflutate 2.5 mg transrectal injectable (FT) exhibited prominent long-term (LT) safety and efficacy for the treatment of benign prostatic hyperplasia (BPH). The inference drawn was that FT 2.5 mg served as a safe and effective transrectal injectable for LT treatment of BPH. The necessity of BPH intervention was reduced due to FT therapy. Furthermore, it led to a reduction in the incidence of prostate cancer (PCa) and acute urinary retention (AUR).

Methods

• This research incorporated the analysis of 2 placebo controlled double-blind randomized parallel group trials with 995 BPH patients at 72 sites treated 3:2 FT:placebo, with open-label FT crossover (CO) re-injection in 2 trials.
• Experts examined individuals (n = 344) with a long-term follow-up (LF) 2-6.75 years (mean 3.58 years, median 3.67 years; FT re-injection CO mean 4.27 years, median 4.42 years).
• Herein, 12 months post-treatment patients did not opt for additional treatment, approved oral medications, FT, or interventional treatment.
• Change in Symptom Score (IPSS) at 12 months and at LF served as the primary endpoint variable.
• CO primary co-endpoints included 3-year incidence of (1) surgery for BPH in FT treated CO patients vs patients crossed over to oral BPH medications and (2) surgery or acute urinary retention in FT-treated CO placebo patients in contrast with placebo patients crossed over to oral BPH medications.
• During this study, 28 CO secondary endpoints evaluated the surgical and symptomatic outcomes in FT reinjected patients in comparison with conventional BPH medication CO and control subgroups at 2 and 3 years.

Results

• No substantial safety variations were reported with FT injection and placebo.
• In FT treated patients, the LF IPSS change from baseline was higher compared to placebo (median FT group improvement - 5.2 vs placebo - 3.0, p < 0.0001).
• A reduction was noted in LF incidence of AUR (1.08% p= 0.0058) and prostate cancer (PCa) (1.1% p=0.0116) in FT treated patients.
• Additionally, a reduction was achieved in the LF incidence of intervention for BPH in the FT group when compared to oral BPH medications (8.08% vs 27.85% at 3 years, p < 0.0001).
• Data illustrated that the LF incidence of intervention or AUR in placebo CO group with FT was reduced when compared to placebo CO group with oral medications (6.07% vs 33.3% at 3 years, p < 0.0001).
• As per the outcomes, 28/28 secondary efficacy endpoints were attained in LF CO re-injection studies.