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ePoster Display

265P - Study of samuraciclib (CT7001), a first-in-class, oral, selective inhibitor of CDK7, in combination with fulvestrant in patients with advanced hormone receptor positive HER2 negative breast cancer (HR+BC)

Date

16 Sep 2021

Session

ePoster Display

Presenters

Sacha Howell

Citation

Annals of Oncology (2021) 32 (suppl_5): S457-S515. 10.1016/annonc/annonc689

Authors

S.J. Howell1, M.G. Krebs2, S. Lord3, L. Kenny4, A. Bahl5, G. Clack6, E. Ainscow7, H. Arkenau8, J.L. Mansi9, C. Palmieri10, P. Richards11, R. Jeselsohn12, Z. Mitri13, W.J. Gradishar14, S. Sardesai15, J. O'Shaughnessy16, M. Lehnert6, S. Ali17, S. McIntosh18, R..C. Coombes19

Author affiliations

  • 1 Division Of Cancer Sciences, The University of Manchester, M13 9PL - Manchester/GB
  • 2 Experimental Cancer Medicine Team, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 3 N/a, University of Oxford, Churchill Hospital, Oxford/GB
  • 4 Early Phase Clinical Trials (cancer),, Imperial College Healthcare NHS Trust - Charing Cross Hospital, W6 8RF - London/GB
  • 5 Preclinical Research, Carrick Therapeutics, Dublin/IE
  • 6 Clinical Research, Carrick Therapeutics, Dublin/IE
  • 7 Discovery, Carrick Therapeutics, D04 V2P1 - Dublin/IE
  • 8 Scri, Sarah Cannon Research Institute SCRI UK, W1G 6AD - London/GB
  • 9 Oncology, Guy's and St. Thomas' Hospital NHS Trust, SE1 9RT - London/GB
  • 10 Cancer Medicine Department, NHS Liverpool Clinical Laboratories - Royal Liverpool University Hospital NHS Trust, L69 3GA - Liverpool/GB
  • 11 Oncology, US Oncology, Salem/US
  • 12 Medical Oncology, Dana-Farber Cancer Institute, Boston/US
  • 13 Medical Oncology, OHSU Knight Cancer Institute, Portland/US
  • 14 Medical Oncology, Northwestern University Feinberg School of Medicine, 60611 - Chicago/US
  • 15 Medical Oncology, Ohio State University, Columbus/US
  • 16 Medical Oncology, Texas Oncology - Baylor Sammons Cancer Center, 75246 - Dallas/US
  • 17 Surgery & Cancer, Imperial College Healthcare NHS Trust - Charing Cross Hospital, London/GB
  • 18 Clinical Research, Carrick Therapeutics, SK10 4TG - Macclesfield, Manchester/GB
  • 19 Clinical Research, Imperial College London - Hammersmith Hospital, W12 0HS - London/GB
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Abstract 265P

Background

CDK7 inhibition is a promising therapeutic strategy in cancer; acting as a regulator of transcription, the cell cycle and endocrine receptor signalling. Patients with HR+BC post CDK4/6 inhibitor treatment have a poor prognosis; median progression free survival (mPFS) of ∼ 8 weeks for fulvestrant post CDK4/6i in HR+BC [1,2]. Pre-clinical HR+BC models indicate the potential for synergy when the CDK7 inhibitor samuraciclib is combined with fulvestrant [3].

Methods

This single arm cohort assessed the tolerability and efficacy of samuraciclib in combination with fulvestrant in patients with advanced HR+BC; all patients had previously received an aromatase inhibitor and a CDK4/6 inhibitor for advanced disease.

Results

31 patients with HR+BC received the combination of standard dose with fulvestrant and samuraciclib. 6 patients received samuraciclib dose of 240mg once daily (OD) and 25 patients a dose of 360mg (OD). The combination treatment was generally well tolerated, with adverse drug reactions (AE) of note being G1-2 nausea, vomiting and diarrhoea; the majority of patients staying on treatment until disease progression. RECIST evaluation indicates evidence of reduction in tumor disease burden, including a partial response in one patient who has been on treatment for ∼ 1 year. Graphic illustrations of data, including ‘waterfall’ and ‘swimmer’ plots, will be presented.

Conclusions

Samuraciclib has demonstrated an acceptable safety profile with evidence of anti-tumour activity in combination with fulvestrant for patients with advanced HR+BC who have progressed on their prior CDK4/6i. References: 1. Juric D et al., SABCS 2018; 2. Baselga J et al. Lancet Oncol 2017; 3. Jeselsohn et al., SABCS 2019.

Clinical trial identification

2017-00202620.

Editorial acknowledgement

Legal entity responsible for the study

Carrick Therapeutics.

Funding

Carrick Therapeutics.

Disclosure

M.G. Krebs: Financial Interests, Personal, Advisory Board: Roche; Financial Interests, Personal, Advisory Board: Janssen; Financial Interests, Personal, Advisory Board: Bayer; Financial Interests, Personal, Advisory Board: Seattle Ger; Financial Interests, Personal, Advisory Board: OM Pharma; Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Speaker’s Bureau: Janssen; Financial Interests, Personal, Other, Travel expenses: BerGenBio; Financial Interests, Personal, Other, travel expenses: Immutep; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: BerGenBio; Financial Interests, Personal, Advisory Board: Achillies Therapeutics; Financial Interests, Institutional, Principal Investigator: Carrick; Financial Interests, Institutional, Principal Investigator: Turning Poi; Financial Interests, Institutional, Principal Investigator: Janssen; Financial Interests, Institutional, Principal Investigator: Roche; Financial Interests, Institutional, Principal Investigator: AstraZeneca; Financial Interests, Institutional, Principal Investigator: Blueprint; Financial Interests, Institutional, Principal Investigator: BerGenBio; Financial Interests, Institutional, Principal Investigator: Immutep; Financial Interests, Institutional, Principal Investigator: Astellas; Financial Interests, Institutional, Principal Investigator: Seattle Ger. A. Bahl, G. Clack: Financial Interests, Personal, Full or part-time Employment: Carrick Therapeutics; Financial Interests, Personal, Stocks/Shares: Carrick Therapeutics. E. Ainscow: Financial Interests, Personal, Stocks/Shares: Carrick Therapeutics; Financial Interests, Personal, Full or part-time Employment: Carrick Therapeutics; Financial Interests, Personal, Stocks/Shares: AstraZeneca. M. Lehnert: Financial Interests, Personal, Stocks/Shares: Carrick Therapeutics. S. Ali: Financial Interests, Personal, Stocks/Shares: Carrick Therapeutics; Non-Financial Interests, Institutional, Full or part-time Employment: IMperial College Hospital. S. McIntosh: Financial Interests, Personal, Stocks/Shares: Carrick Therapeutics; Financial Interests, Personal, Full or part-time Employment: Carrick Therapeutics. R.C. Coombes: Financial Interests, Personal, Stocks/Shares: Carrick Therapeutics. All other authors have declared no conflicts of interest.

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