Key clinical point: Men with metastatic castration-resistant prostate cancer (mCRPC) who receive sipuleucel-T at any time have significantly prolonged overall survival compared with those who receive androgen-receptor signaling pathway inhibitors (ASPIs) alone.
Major finding: In a retrospective cohort analysis of treatment-naive men with mCRPC, first-line sipuleucel-T vs first-line ASPIs (first-line cohort) and any-line sipuleucel-T vs any-line ASPIs (any-line cohort) were compared.
Study details: Median OS was higher with sipuleucel-T vs ASPI in the any-line cohort (35.2 vs 20.7 months) and the first-line cohort (34.9 vs 21.0 months). At 36 months, sipuleucel-T vs ASPIs was associated with significantly prolonged OS in the any-line cohort (adjusted hazard ratio [aHR], 0.59; P less than .0001) and the first-line cohort (aHR, 0.56; P less than .0001).
Disclosures: The study was sponsored by Dendreon Pharmaceuticals, LLC. The authors reported relationships with various pharmaceutical companies, including Dendreon Pharmaceuticals, LLC. HM Wilfehrt and SC Flanders were employees of Dendreon Pharmaceuticals, LLC when the study was being conducted.
“Sipuleucel-T is an autologous vaccine derived from processing of a patient’s leukapharesed immune cells and is utilized in men with metastatic castration-resistant prostate cancer (mCRPC) without visceral metastases. Since its approval, newer agents that act on androgen signaling, such as abiraterone and enzalutamide, have also been widely utilized. In this retrospective cohort study, men with mCRPC and chemo-naïve were identified via a Medicare database. Patients treated in the 1) first-line and 2) any-line setting with sipuleucel-T were compared with patients receiving other androgen signaling inhibitors treated first-line or any-line, respectively.
Overall survival was higher for men receiving sipuleucel-T compared to other androgen signaling inhibitors in both scenarios. However, while the two groups were matched on several characteristics, it is difficult to identify bias in treatment selection via database analysis. Thus, this exploratory analysis does warrant further study in patients without visceral disease.”
Mark Klein, MD
McKay RR et al. Cancer Adv Ther. 2020 Oct 7. doi: 10.1007/s12325-020-01509-5.