Long-term follow-up from STAMP, a phase II trial, evaluating sipuleucel-T and concurrent (CON) vs sequential (SEQ) abiraterone acetate + prednisone in metastatic castration-resistant prostate cancer patients (pts).

Authors

Eric Small

Eric Jay Small

University of California, San Francisco, San Francisco, CA

Eric Jay Small , Raymond S. Lance , Charles H. Redfern , Frederick E. Millard , Thomas A. Gardner , Nancy Ann Dawson , Lawrence Fong , Lawrence Ivan Karsh , John M. Corman , Luke T. Nordquist , Myron I Murdock , Brendan D. Curti , Nancy N. Chang , Neal D. Shore

Organizations

University of California, San Francisco, San Francisco, CA, Eastern Virginia Medical School, Norfolk, VA, Oncology Associates of San Diego, San Diego, CA, Moores Cancer Center, University of California, San Diego, La Jolla, CA, Indiana University School of Medicine, Indianapolis, IN, Lombardi Comprehensive Cancer Center, Washington, DC, The Urology Center of Colorado, Denver, CO, US Oncology Research, Comprehensive Cancer Centers of Nevada, Medical Oncology, Las Vegas, NV, Urology Cancer Center and GU Research Network, Omaha, NE, MidAtlantic Urology Associates, Greenbelt, MD, Earle A. Chiles Research Institute, Providence Cancer Center, Portland, OR, Dendreon Pharmaceuticals, Inc., Seattle, WA, Carolina Urologic Research Center, Myrtle Beach, SC

Research Funding

Pharmaceutical/Biotech Company

Background: The optimal sequence and combination of life-extending anticancer therapies in mCRPC pts remains unknown. Sipuleucel-T (sip-T), an autologous cellular immunotherapy approved for the therapy of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC) pts, was evaluated in combination with abiraterone acetate and prednisone (abi) in the phase II STAMP trial (NCT01487863), with pts randomly assigned to receive CON sip-T + abi or SEQ sip-T followed by abi. The combination was well-tolerated and did not alter the immune response parameters that correlate with overall survival (OS) (Small Clin Can Res 2015). Here, we present long-term follow-up of clinical outcomes, including OS. Methods: mCRPC pts were randomized 1:1 to CON or SEQ therapy with sip-T and abi. Abi began 1 day after (CON) or at wk 10 (SEQ) after the first sip-T infusion and continued for 26 wk of therapy, after which continued abi therapy was permitted. Long-term clinical outcomes included OS, disease-specific death (DSS), progressive disease (PD), time to first anticancer intervention (tACI), and safety. Results: 69 pts were enrolled (35 CON; 34 SEQ). Median OS was 34.0 mo (95% CI, 24.4-not estimable [NE]; 30.0 mo CON; 34.2 mo SEQ; p = 0.921), and median time to DSS was not reached (CON vs SEQ; p = 0.733). Median time to PD was 17.3 mo (95% CI, 9.7–NE; 17.7 mo CON vs 13.9 mo SEQ; p = 0.914; consistent with higher rates of abi discontinuation due to PD in SEQ [26.5% vs 14.3% in CON]). tACI was similar between arms at 15.4 mo (95% CI, 11.0–19.9). No new safety signals were observed with the combination, and no discernable difference in clinical outcomes was observed with CON or SEQ treatments. Conclusions: Long-term follow-up data confirm that sip-T + CON or SEQ abi is well-tolerated, with no new safety signals. No clear differences were observed in clinical outcomes between arms, although the study was not powered to detect these differences. Future and more appropriately powered studies on the effect of sip-T + continuous abi for responding pts may provide further insights on the benefit of combination therapy. Clinical trial information: NCT01487863

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Abstract Details

Meeting

2017 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Prostate Cancer

Track

Prostate Cancer,Prostate Cancer

Sub Track

Prostate Cancer - Advanced Disease

Clinical Trial Registration Number

NCT01487863

Citation

J Clin Oncol 35, 2017 (suppl 6S; abstract 190)

DOI

10.1200/JCO.2017.35.6_suppl.190

Abstract #

190

Poster Bd #

G19

Abstract Disclosures