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 session3310 - Efficacy of panitumumab and cetuximab in patients 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 3563 - Multicenter randomized phase II trial (BEVATOMOX) assessing the Raltitrexed, Oxaliplatin and Bevacizumab combination versus FOLFOX6 Bevacizumab as 2nd line treatment in metastatic colorectal cancer (mCRC)Presenter: Emmanuelle Samalin Session: Poster display session Resources: Abstract 3592 - Safety analysis of phase Ib study of FOLFOXIRI plus ramucirumab as first-line therapy for patients with metastatic colorectal cancerPresenter: Hiroya Taniguchi Session: Poster display session Resources: Abstract 4429 - Prognostic factors and specific populations in the pharmacogenetic randomized phase II trial of FOLFIRI with high-dose (HD) of irinotecan vs standard doses in metastatic colorectal cancer (mCRC) patients (pts) according to UGT1A1 genotype.Presenter: María Tobeña Session: Poster display session Resources: Abstract 1781 - Analysis of efficacy and prognostic factors in second-line chemotherapy for BRAF V600E mutant metastatic colorectal cancerPresenter: Seiichiro Mitani Session: Poster display session Resources: Abstract 1098 - A large retrospective multicenter study evaluating prognosis and chemosensitivity of metastatic colorectal cancer with microsatellite instabilityPresenter: David Tougeron Session: Poster display session Resources: Abstract 2538 - Exploratory analysis of baseline microsatellite instability (MSI) status in patients with metastatic colorectal cancer (mCRC) treated with regorafenib (REG) or placebo in the phase 3 CORRECT trialPresenter: Karl Köchert Session: Poster display session Resources: Abstract 2451 - Investigation of MSI Status in Acquired Resistance to 5-Fluorouracil Treatment in Colorectal Cancer Using a SILAC-Based Quantitative Proteomic Analysis MethodPresenter: Mario Ortega Duran Session: Poster display session Resources: Abstract 1658 - Docetaxel, Cisplatin, and 5-fluorouracil (DCF) chemotherapy in the treatment of metastatic or unresectable locally recurrent anal squamous cell carcinoma: a phase II study of French interdisciplinary GERCOR and FFCD Groups (Epitopes-HPV02 study)Presenter: Stefano Kim Session: Poster display session Resources: Abstract Slides 2319 - P2 study of ADXS11-001 Immunotherapy in patients with persistent/recurrent, surgically unresectable locoregional, or metastatic squamous cell anal cancerPresenter: Cathy Eng 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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