Abstract 5696
Background
SFX-01 is a proprietary synthetic pharmaceutical product based upon a stabilised sulforaphane. In preclinical models SFX-01 inhibits the activity of cancer stem-like cells and reverses resistance to endocrine therapies (ET) tamoxifen (Tam) and fulvestrant (Fulv). The STEM study investigated the potential of SFX-01 to reverse acquired resistance to Tam, Fulv and third generation aromatase inhibitor (AI) therapy.
Methods
STEM is an open label parallel arm exploratory phase II trial. Patients were eligible if they had measurable (RECIST v1.1) estrogen receptor (ER) positive Her2- mBC that had developed acquired resistance to AI (arm A), Tam (arm B) or Fulv (arm C) therapy i.e. mBC was progressing having shown clinical benefit (stable disease (SD) for 6 months or objective response (OR)). SFX-01 300mg bd po was added to the current ET. The co-primary endpoints were clinical benefit rate (CBR) and safety/tolerability. Secondary endpoints included OR rate (ORR) and time to progression (TTP). Patients progression free at 24wks were enrolled into a compassionate use phase to continue SFX-01 and the same ET.
Results
Between January 2017 and July 2018 46 patients were recruited; arm A n = 31, arm B n = 8 and arm C n = 7. 33/46 (71.7%) had visceral involvement. Prior lines of ET were: 1= 17/46 (37.0%), 2= 17/46 (37.0%) and ≥3 = 12 (26%). 8 patients (17.4%) had received prior chemotherapy for mBC. The CBR overall was 12/46 (26.0%) with 2 objective responses (both partial). SFX-01 was well tolerated with grade 1/2 nausea (54.3%) and dyspepsia (32.6%) the most frequent adverse events (AEs). Only 2 grade 3 AEs were possibly drug related. There were no drug related serious AEs. There was no significant association between duration of prior ET and subsequent duration of ET+SFX-01 (Spearman r 0.17; p = 0.26).
Conclusions
SFX-01 300 mg BID was safe and well tolerated in patients with ER+ and HER2- mBC. SFX-01 in combination with ET demonstrated anti-tumour activity and prolonged disease stabilisation in pre-treated patients who were progressing on the background ET at study entry. Further development of SFX-01 in ER+ mBC is warranted.
Clinical trial identification
NCT02970682.
Editorial acknowledgement
Legal entity responsible for the study
Evgen Pharma PLC.
Funding
Evgen Pharma PLC.
Disclosure
S.J. Howell: Research grant / Funding (self), Travel / Accommodation / Expenses: Evgen Pharma PLC. S. Ross: Full / Part-time employment: Evgen Pharma PLC. T. Morris: Full / Part-time employment: Evgen Pharma PLC. S. Franklin: Leadership role, Shareholder / Stockholder / Stock options, Full / Part-time employment, Officer / Board of Directors: Evgen Pharma PLC. All other authors have declared no conflicts of interest.
Resources from the same session
5489 - Local immune status in cancer cell nests can be a predictor of survival for rectal cancer with neoadjuvant radiotherapy
Presenter: xijin lin
Session: Poster Display session 2
Resources:
Abstract
1653 - Impact of concomitant medications on disease free survival (DFS) and overall survival (OS) in patients from the PETACC8 study.
Presenter: Clémence Brun
Session: Poster Display session 2
Resources:
Abstract
5206 - Updated results of NORDIC 8, a randomised trial of cetuximab every 2 weeks with FOLFIRI or cetuximab with alternating FOLFIRI/FOLFOX in patients with RAS and BRAF wild type metastatic colorectal cancer.
Presenter: Per Pfeiffer
Session: Poster Display session 2
Resources:
Abstract
2992 - Clinical impact of mucinous and poorly differentiated tumors on the outcome of patients with stage II colon cancer: a TOSCA subgroup analysis
Presenter: Gerardo Rosati
Session: Poster Display session 2
Resources:
Abstract
4753 - Exercise improved adjuvant treatment completion rates and treatment-related toxicities in colorectal cancer: A prospective pilot study
Presenter: Hong Jun Kim
Session: Poster Display session 2
Resources:
Abstract
2735 - Bevacizumab plus Oxaliplatin-Based Chemotherapy as Adjuvant Treatment for Colon Cancer (CC): Updated analysis of stage II disease from the AVANT Phase III Randomized trial by the GERCOR Group
Presenter: Aimery De Gramont
Session: Poster Display session 2
Resources:
Abstract
1843 - Multicenter Validation of the Postoperative Carcinoembryonic Antigen Combined Prognostic Model for Stage Ⅲ Colon Cancer
Presenter: Ji Zhu
Session: Poster Display session 2
Resources:
Abstract
2554 - Impact of the IDEA study on clinical practice for stage III colon cancer patients: a French GERCOR - FFCD - GI UNICANCER national survey.
Presenter: Kaissa Ouali
Session: Poster Display session 2
Resources:
Abstract
3285 - Sex hormones and sperm parameters after adjuvant oxaliplatin-based treatment for colorectal cancer
Presenter: Philip Falk
Session: Poster Display session 2
Resources:
Abstract
3905 - Loss of CDX-2 expression is an independent poor prognostic biomarker in colorectal cancer
Presenter: Krittiya Korphaisarn
Session: Poster Display session 2
Resources:
Abstract