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
1058 - Assessment of CPS+EG, Neo-Bioscore and modified Neo-Bioscore in breast cancer patients treated with preoperative systemic therapy: a multicenter cohort study
Presenter: LING XU
Session: Poster Display session 2
Resources:
Abstract
1156 - The concordance of treatment decision guided by Oncotype and the PREDICT tool in early stage breast cancer
Presenter: Hadar Goldvaser
Session: Poster Display session 2
Resources:
Abstract
3447 - Influence of first treatment delay on survival among breast cancer subtypes
Presenter: Irene Zarcos Pedrinaci
Session: Poster Display session 2
Resources:
Abstract
3505 - Clinical features of early-stage (I-III) triple-negative breast cancer (TNBC) patients with tumors exhibiting low-overall change in molecular profile after neoadjuvant therapy.
Presenter: Nour Abuhadra
Session: Poster Display session 2
Resources:
Abstract
5442 - Meta-analysis in HER2+ early breast cancer therapies and cost-effectiveness in a Brazilian perspective
Presenter: Marcos Magalhaes
Session: Poster Display session 2
Resources:
Abstract
1570 - Anti-mullerian hormone (AMH) levels and antral follicle counts (AFC) may predict ovarian reserves before systemic chemotherapy (SC) in women with breast cancer(BC); a prospective clinical study
Presenter: Cetin Ordu
Session: Poster Display session 2
Resources:
Abstract
2698 - Prognosis of selected triple negative apocrine breast cancer patients who did not receive adjuvant chemotherapy.
Presenter: Giuseppe Cancello
Session: Poster Display session 2
Resources:
Abstract
3104 - Novel Blood Based Circulating Tumor Cell Biomarker For Breast Cancer Detection
Presenter: Chun-Yu Liu
Session: Poster Display session 2
Resources:
Abstract
4631 - Multi-Gene Prognostic Signatures and Prediction of Pathological Complete Response of ER-Positive HER2-Negative Breast Cancer Patients to Neo-Adjuvant Chemotherapy
Presenter: Claudia Mazo
Session: Poster Display session 2
Resources:
Abstract
4632 - Impact of menopause status on breast cancer outcomes and amenorrhea incidence during adjuvant tailored dose dense chemotherapy
Presenter: Andri Papakonstantinou
Session: Poster Display session 2
Resources:
Abstract