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Published on: March 6, 2018
A pilot study of the liposomal MUC1 vaccine BLP25 in prostate specific antigen failures after radical prostatectomy
S A North1, K Graham, D Bodnar
1Cross Cancer Institute and Biomira, Inc., 11560 University Avenue, Edmonton, Alberta, Canada. scottnor@cancerboard.ab.ca
Purpose:
Men with biochemical failure after radical prostatectomy have few therapeutic options other than androgen deprivation therapy. Targeted therapies in this group are appropriate because the optimal timing of the initiation of hormonal therapy in this patient population is unknown. A single institution pilot trial was performed using BLP25 liposome vaccine in hormone naïve patients with prostate specific antigen failure after radical prostatectomy to determine if prostate specific antigen progression could be halted.
Materials And Methods:
Men with biochemical failure after radical prostatectomy were enrolled. Primary end points were efficacy and safety of the MUC1 BLP25 liposomal vaccine. Changes in prostate specific antigen doubling time were also evaluated. Patients received a single intravenous dose of cyclophosphamide, followed by vaccinations with BLP25 liposome vaccine for up to 1 year. Prostate specific antigen was measured at baseline and during treatment, and prostate specific antigen doubling time was calculated for these intervals.
Results:
A total of 16 patients with a median age of 60 years were enrolled. All patients received cyclophosphamide and 15 of 16 completed the primary treatment period. Ten patients completed the maintenance period. After the 8-week primary treatment period 8 of 16 patients had stable or decreased prostate specific antigen. At the last on-study prostate specific antigen measurement 1 patient maintained stable prostate specific antigen but all others had progression. However, 6 of the 16 patients had greater than 50% prolongation of prostate specific antigen doubling time compared to pre-study prostate specific antigen doubling time.
Conclusions:
BLP25 liposome vaccine shows promise for prolonging prostate specific antigen doubling time in hormone naïve men with biochemical failure after prostatectomy and little morbidity. This could potentially translate into the deferral of hormonal therapy. Further testing in this population of patients is warranted.
Insights
The BLP25 liposome vaccine may help delay androgen deprivation therapy for men with prostate specific antigen failure after prostatectomy. This novel immunotherapy showed promise in prolonging prostate specific antigen doubling time with minimal side effects.
Area of Science:
- Oncology
- Immunotherapy
- Urologic Oncology
Background:
- Men with biochemical failure post-prostatectomy have limited treatment options beyond androgen deprivation therapy.
- The optimal timing for initiating hormonal therapy in this patient group remains unclear.
- Targeted therapies are needed for men experiencing prostate specific antigen recurrence after radical prostatectomy.
Purpose of the Study:
- To evaluate the efficacy and safety of the BLP25 liposome vaccine in hormone-naïve men with biochemical failure after radical prostatectomy.
- To determine if the BLP25 liposome vaccine can halt or slow prostate specific antigen progression.
- To assess changes in prostate specific antigen doubling time as a measure of treatment response.
Main Methods:
- A pilot trial involving 16 men with biochemical failure after radical prostatectomy.
- Patients received an initial dose of cyclophosphamide followed by BLP25 liposome vaccine vaccinations for up to one year.
- Prostate specific antigen levels and doubling times were monitored throughout the study.
Main Results:
- Eight of 16 patients achieved stable or decreased prostate specific antigen after the initial 8-week treatment period.
- Six patients experienced a prolongation of their prostate specific antigen doubling time by over 50%.
- The BLP25 liposome vaccine demonstrated a favorable safety profile with low morbidity.
Conclusions:
- The BLP25 liposome vaccine shows potential for prolonging prostate specific antigen doubling time in hormone-naïve men with post-prostatectomy biochemical failure.
- This immunotherapy may offer a strategy to defer androgen deprivation therapy.
- Further clinical investigation of the BLP25 liposome vaccine in this patient population is warranted.
