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 session3085 - Sequential therapy with bevacizumab and epidermal growth factor receptor-directed agents for metastatic colorectal carcinoma: a retrospective, registry-based analysisPresenter: Tomas Buchler Session: Poster display session Resources: Abstract 3551 - Outcomes in patients receiving maintenance therapy in two panitumumab (Pmab) first-line trials for metastatic colorectal cancer (mCRC)Presenter: Fernando Rivera Herrero Session: Poster display session Resources: Abstract 2191 - AMALTHEA: A prospective, single-arm study of the Hellenic Cooperative Oncology Group evaluating the efficacy and safety of 1st line FOLFIRI+Aflibercept in patients with metastatic colorectal cancer.Presenter: George Pentheroudakis Session: Poster display session Resources: Abstract Slides 2559 - Multicenter phase II study of biweekly XELIRI plus Bevacizumab as a second-line therapy in patients with metastatic colorectal cancer (JSWOG-C3 study)Presenter: Yoshiko Mori Session: Poster display session Resources: Abstract 3760 - Sex-related differences in circadian-dependent tolerance of Irinotecan (I) added to chronomodulated (chrono) 5-Fluorouracil (F), Leucovorin (L) and Oxaliplatin (O): final results from international randomised time-finding study in patients with metastatic colorectal cancer (MCC).Presenter: Francis Levi Session: Poster display session Resources: Abstract 4280 - Mechanism of Pelareorep (Pel)-mediated cell death in a Phase I study in combination with irinotecan/ fluorouracil/ leucovorin/ bevacizumab (FOLFIRI/B) in patients with KRAS mutant metastatic colorectal cancer (mCRC)Presenter: SANJAY GOEL Session: Poster display session Resources: Abstract 2889 - Bevacizumab first line and impact on subsequent anti-EGFR activity.Presenter: Timothy Price Session: Poster display session Resources: Abstract 5158 - Efficacy of anti-EGFR antibodies combined with chemotherapy for elderly patients with RAS wild-type Metastatic Colorectal Cancer: A Systematic Review and Metanalysis.Presenter: Lorenzo Belluomini Session: Poster display session Resources: Abstract 5502 - Efficacy of panitumumab and cetuximab in elderly patients (aged ≥75) with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (mCRC): retrospective analysis of data from nationwide Drug-Reimbursement-Access ProgramPresenter: Marcin Swierkowski Session: Poster display session Resources: Abstract 3493 - Toxicity and efficacy of flat-dosed versus body-surface area (BSA)-dosed capecitabinePresenter: Femke Man 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.
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