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New blood cancer drug combinations to be tested in latest clinical trial

The latest trial in the Myeloma UK Clinical Trial Network, MUK Twelve, has launched. The trial will test selinexor in combination for the first time. Selinexor is the first in a new family of drugs known as Selective Inhibitor of Nuclear Export (SINE™) compounds. It works by blocking the action of a protein (XPO1) in the nucleus of myeloma cells.

Press release, Research news // 28th September 2018

MUK Twelve is the latest trial to be launched in the Myeloma UK Clinical Trials Network. The trial is looking to test two different drug combinations; 1) selinexor, cyclophosphamide and prednisolone (SCP) and 2) cyclophosphamide and prednisolone (CP) followed by selinexor, cyclophosphamide and prednisolone (SCP). It is the first time selinexor will be trialled in combination with cyclophosphamide and prednisolone.

Selinexor is the first in a new family of drugs known as Selective Inhibitor of Nuclear Export (SINE™) compounds. It works by blocking the action of a protein (XPO1) in the nucleus of myeloma cells. This protein is responsible for moving other proteins out of the nucleus of a cell. In myeloma cells, by blocking this protein, other proteins are not moved and the myeloma cell dies.

The trial is now open for recruitment and looks to have up to 60 patients taking part from hospitals throughout the UK. The aim is to compare two different combinations of drugs used to treat myeloma, in patients who have relapsed after two or more previous treatments or have not responded to previous treatments. The trial also looks to determine if the addition of selinexor to the CP combination leads to an increased progression-free survival rate.

This is a prioritised study within the Myeloma UK CTN and is being run by the Clinical Trials Research Unit (CTRU) at the University of Leeds. Karyopharm Therapeutics are supporting the trial by providing selinexor free of charge and funding the study.

Dr Simon Ridley, Director of Research at Myeloma UK said, “The MUK Twelve trial is an opportunity to evaluate selinexor in combination with two well-established drugs and we hope to see evidence of benefit. Over 17,500 patients live with myeloma in the UK and it remains an incurable blood cancer.  It is encouraging to see promising new drugs such as selinexor coming through the pipeline into clinical trials through the Myeloma UK Clinical Trials Network”.

Chief Investigator of the MUK Twelve clinical trial Dr. Martin Kaiser, Clinician Scientist at The Institute of Cancer Research, London, and Consultant Haematologist at The Royal Marsden NHS Foundation Trust, said, “We are very excited to have MUK Twelve open for patients to join. Findings from other studies so far suggest that selinexor could be a great new addition to our arsenal of myeloma treatments. In the trial, we specifically study a combination of selinexor with low doses of existing standard treatments cyclophosphamide and prednisolone, which we hope will make the combination well tolerated. By combining drugs that are generally accessible to patients on the NHS, we hope that study, if successful, could improve future treatment options for our patients.”

Dr Sadie Reed from University of Leeds CTRU said, “We are pleased to be working in partnership with Dr Kaiser and Karyopharm to open MUK Twelve through the Myeloma UK CTN network, to enable patient access to the exciting new drug selinexor. There has been a lot of excitement over the trial and we are looking forward to opening further sites across the UK.

Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm said, “We are encouraged by the upcoming start of the MUK Twelve trial and share Myeloma UK’s sense of urgency in advancing the treatment options available for patients with myeloma. This trial is particularly important as it will be studying a convenient, all oral regimen which could have significant implications for improving patient care. The findings will help advance the development of selinexor and allow us to better understand its applicability in combination with cyclophosphamide in patients with relapsed or refractory disease. We look forward to partnering with the Myeloma UK CTN and University of Leeds CTRU on this very important endeavour.”