Abstract 1704
Background
Despite toxicity and no clear clinical benefit, non-metastatic recurrent prostate cancer (nmPC) is typically treated with medical castration in North America. SM88 is a non-toxic novel combination therapy based on the Warburg effect, with activity in a variety of cancers including prostate (JCO 2017 e Abstract1). End of phase 1 results demonstrated stable or rising testosterone levels while achieving CTC (circulating tumor cells) benefit and no radiographic progression events (JCO 2017e Abstract2). We now report phase II data.
Methods
Starting in Sept 2016, a prospective Phase Ib/II of SM88 (230mg po bid) enrolled recurrent nmPC with rising PSA (PCWG3 definition) and detectable CTCs, but no radiographically identified lesions.
Results
8 (of 34 planned) subjects have completed at least 1 cycle (median 5, range 1-7). Mean age was 69.7 (62-80); all had prior ADT after curative intent RT (50%) or surgery (50%); no patient is currently on ADT. Mean testosterone level (T) was 581.4 ng/dL and rose or remained stable in the subjects except for one patient who entered the trial castrate (30% (n = 4); at up to 6 cycles, no PSA progression (PCWG3) and no radiographic progression was reported (n = 8). No subject required other toxic therapy (100% subsequent treatment free survival). Available preliminary neutrophile:lymphocyte ratio (N::L)(n = 6) improved while urinary NTx, bone specific AlkPhos and LDH trends were essentially unchanged.Table:
797P
| subject # | cycles completed | T ng/dL | CTCs baseline | Max Decrease | N:L Max Decrease |
|---|---|---|---|---|---|
| 1 | 6 | 635.7 | 26.75 | 100% | 78% |
| 2 | 6 | ConclusionsWe propose that hormonal castration is not necessary for nmPC disease control based on a preliminary assessment of both Phase Ib and II data of SM88. CTCs and N::L were improved while maintaining normal T. These early biomarker indicators are consistent with the observed 100% radiographic progression free survival and avoidance of additional toxic therapy. A phase III RCT is planned for confirmation of these results. Clinical trial identificationLegal entity responsible for the studyTyme Inc FundingTyme Inc DisclosureG. Del Priore, S. Hoffman, G. Sokol: Current or potential ownership of stock or options and/or salary support from Tyme Inc. W-T. Chen, H. Dong: Employee of Vitatex. Tyme Inc has a commercial relationship with Vitatex whereby Vitatex provides blinded results to the CRO supervising the ongoing clinical trial. Resources from the same session4068 - Comparison of Breast Cancer Subtypes between young and elderly womenPresenter: Ivane Kiladze Session: Poster display session Resources: Abstract 5055 - Distribution of the PAM50 breast cancer subtypes within each pathology-based group: a combined analysis of 15,339 patients across 29 studiesPresenter: Juan Miguel Cejalvo Session: Poster display session Resources: Abstract 2210 - Genetic Association of Matrix metalloproteinase MMP- 1, MMP-3 and MMP-9 Genes with HCV-related Hepatocellular Carcinoma in Egyptian patientsPresenter: Alshimaa Alhanafy Session: Poster display session Resources: Abstract 4523 - Heterogenity of Epigenetic and EMT Marks Observed in Hepatocellular Carcinoma with Keratin 19 ProficiencyPresenter: Takeshi Nagasaka Session: Poster display session Resources: Abstract 624 - Rare malignancy rare site - Extranodal lymphomasPresenter: Sumant Gupta Session: Poster display session Resources: Abstract 5126 - Descriptive analysis of families with TP53 mutations: Is there a genotype/phenotype correlation?Presenter: José Silva Session: Poster display session Resources: Abstract This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. For more detailed information on the cookies we use, please check our Privacy Policy.
|