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
5124 - STAR_PAC: Phase I clinical trial repurposing all trans retinoic acid (ATRA) as stromal targeting agent in a novel drug combination for pancreatic cancer.
Presenter: Hemant Kocher
Session: Poster Display session 2
Resources:
Abstract
5257 - Outcomes of First Line FOLFIRINOX (FFX) Versus Gemcitabine and Nab-Paclitaxel (GN) in Patients with Advanced Pancreatic Cancer: Multi-Institutional Canadian Sites Experience
Presenter: Neha Papneja
Session: Poster Display session 2
Resources:
Abstract
1166 - Effect of prior cancer on survival outcomes for patients with pancreatic adenocarcinoma
Presenter: Chaobin He
Session: Poster Display session 2
Resources:
Abstract
1169 - Association of combination of irreversible electroporation ablation and chemotherapy with outcomes of locally advanced pancreatic cancer: a large cohort study
Presenter: Chaobin He
Session: Poster Display session 2
Resources:
Abstract
1222 - Results from phase I study of the oncolytic viral immunotherapy agent Canerpaturev (C-REV) in combination with gemcitabine plus nab-paclitaxel as first-line treatment of unresectable pancreatic cancer
Presenter: Yusuke Hashimoto
Session: Poster Display session 2
Resources:
Abstract
1698 - Multicenter retrospective study of gemcitabine plus nab-paclitaxel for elderly patients with advanced pancreatic cancer
Presenter: Masato Ozaka
Session: Poster Display session 2
Resources:
Abstract
2424 - Irinotecan Combined with Oxaliplatin and S1 in Patients with Metastatic Pancreatic Adenocarcinoma
Presenter: Keke Nie
Session: Poster Display session 2
Resources:
Abstract
2885 - Cancer-associated thrombosis in patients with pancreatic cancer and its correlation with plasma tissue factor level: A Japanese prospective cohort study
Presenter: Satoshi Kobayashi
Session: Poster Display session 2
Resources:
Abstract
3702 - A Phase I/Ib, multi-center trial of ARQ-761 (Beta-Lapachone) with gemcitabine/nab-Paclitaxel in patients with advanced pancreatic cancer
Presenter: Muhammad Beg
Session: Poster Display session 2
Resources:
Abstract
5185 - Systemic administration of the hyaluronidase-expressing oncolytic adenovirus VCN-01 in patients with advanced or metastatic pancreatic cancer: first-in-human clinical trial
Presenter: Rocio Garcia-Carbonero
Session: Poster Display session 2
Resources:
Abstract