Abstract 3611
Background
Androgen deprivation therapy (ADT) is standard treatment for rising PSA with/without circulating tumor cells (CTCs) but adverse events (AEs) limit patient acceptance. We report results of SM-88 (D,L-alpha-metyrosine; racemetyrosine [USAN]) in combination with a CYP3A4 inducer, mTOR inhibitor and catalyst that does not lower testosterone (T).
Methods
Phase 2 with a rising PSA (per PCWG3), no disease on imaging and detectable CTCs.
Results
From Sept 2016-April 2019, 35 subjects consented; 23 evaluable (completed >1 cycle); 60.9% were post RT. Mean age 70.6; BMI 28.9; 21.7% black. Mean T rose (319.1 to 346.0 ng/dL p = 0.08) over 12 weeks. Subjects did not report side effects commonly associated with hormone suppression. Assessments of EORTC measured domains sexual health, overall health, and quality of life remained stable, with depression, hot flushes, and enlarged breast reported as “Not at all” (remained at 1). There was no detectable worsening in any domain of EORTC QLQ-C30 or QLQ-PR25. No clinically significant changes were seen in weight, hct, glu, urinary N telopeptide, MAP (in normotensives and hypertensives), heart rate, Ca ++, LDH, bsAlkPhos, triglycerides, albumin, or QTc. NLR decreased at the end of cycle 1 in 75% of those with radiographic and/or PSA progression vs 53% of those who did not. 15/23 (65.2%) subjects reported experiencing an AE. 1 unrelated Grade 3; 18/35 (51.4%) at least possibly related to drug. No AEs were related to T levels. There were no skeletal or cardiovascular events. From initial diagnosis of PSA rise 100% (23/23) remained metastases free. PSA declined (4% 1/23) stabilized (83% 19/23) or rose (13% 3/23). 56.5% (13/23) subjects experienced an improvement in median PSA DT. Median DT time improved from 6.2 to 8.0 months for all subjects completing 3 cycles of therapy. CTCs were > 5 in 100% at baseline. After 12 weeks, there was a 65.3% (-100% to -8.8%) median CTC decrease from baseline (n = 18), with all subjects having CTC counts below baseline and 2 undetectable.
Conclusions
SM-88 may delay the start of HT and be useful when normal T is preferred. QOL was maintained without ADT AEs. Favorable effects on PSA and CTCs kinetics were observed consistent with a favorable treatment effect. Trials to confirm these benefits are planned.
Clinical trial identification
NCT02796898.
Editorial acknowledgement
Legal entity responsible for the study
Tyme Inc.
Funding
Tyme Inc.
Disclosure
G. Del Priore: Leadership role, Shareholder / Stockholder / Stock options, Full / Part-time employment, Officer / Board of Directors: Tyme Inc. G.H. Sokol: Advisory / Consultancy: Tyme Inc. A. Vandell: Full / Part-time employment: Tyme Inc. All other authors have declared no conflicts of interest.
Resources from the same session
2494 - CAR-T Nursing Education at a UK Specialist Cancer Hospital
Presenter: Rose Ellard
Session: Poster Display session 3
Resources:
Abstract
2438 - Professional Quality of Life, Perceived Stress and Psychological Resistance Levels of Oncology-Hematology Nurses and the Factors Affecting
Presenter: Tugba Pehlivan
Session: Poster Display session 3
Resources:
Abstract
3541 - Representation of cancer survivors’ preferences in policies for supportive care: Implications for oncology nursing
Presenter: Samantha Mayo
Session: Poster Display session 3
Resources:
Abstract
5093 - Vaginal moisturizing post PDR-Pulse Dose Rate Brachytherapy.
Presenter: Pilar Fernández
Session: Poster Display session 3
Resources:
Abstract
1066 - The stomized, chemo and radiotreated patient vs untreated patient: complications and comparison with data literature
Presenter: Cristoforo Ferrero
Session: Poster Display session 3
Resources:
Abstract
1724 - Evaluating the role of clinical nurse specialist
Presenter: Anita Zeneli
Session: Poster Display session 3
Resources:
Abstract
3753 - Role of the Advanced Practice Nurse (APN) in a Functional Unit for Lung cancer at the Catalan Institute of Oncology
Presenter: Isabel Brao
Session: Poster Display session 3
Resources:
Abstract
2676 - A bottom-up approach for prioritising the scientific activities of the Italian Association of Cancer Nurses (AIIAO): rationale and topic identification
Presenter: Valentina Biagioli
Session: Poster Display session 3
Resources:
Abstract
575 - Investigating quality of care for people with cancer and dementia
Presenter: Naomi Farrington
Session: Poster Display session 3
Resources:
Abstract
5578 - Two years of BRCA1 and BRCA2 somatic External Quality Assessment with Gen&tiss Tiss scheme in France
Presenter: Kelly Dufraing
Session: Poster Display session 3
Resources:
Abstract