Elotuzumab (Empliciti®) Horizons Infosheet Clinical Trials and Novel Drugs

Elotuzumab (Empliciti®) Horizons Infosheet Clinical trials and novel drugs

This Horizons Infosheet contains information on elotuzumab (also known as Empliciti®), a drug being investigated for the treatment of myeloma. The Horizons Infosheet series What is Elotuzumab? provides information relating Elotuzumab is a new drug being to novel drugs and treatment investigated for the treatment of strategies that are currently being myeloma. investigated for the treatment of myeloma. The series also aims to Elotuzumab is a monoclonal highlight the considerable amount antibody which attaches to a of research currently taking place in speciﬁc protein that is present on the ﬁeld of myeloma. the surface of myeloma cells.

The drugs and treatment strategies What is a monoclonal described in the Horizons Infosheets antibody? may not be licensed and/or approved for use in myeloma. You Monoclonal antibodies are a class may, however, be able to access of drug being investigated in the them as part of a clinical trial. treatment of myeloma.

Infoline: 0800 980 3332 1 Monoclonal antibodies are made monoclonal monoclonal antibody drug in the laboratory to mimic the antibody drug antibodies that your own immune system produces in response to foreign organisms (such as bacteria) that enter the body. Antibodies recognise proteins on the surface of myeloma myeloma cell harmful or abnormal cells and flag cell them for destruction by the immune proteins system. proteins on the cell on the cell surface surface monoclonal monoclonal antibody locked Monoclonal antibody drugs are antibody locked onto the cell- onto the cell- surface protein designed to recognise and attach surface protein to speciﬁc proteins on the surface Figure 1. Mechanism of action of monoclonal of cancer cells. ‘Monoclonal’ means antibody drugs all one type. This means that each group of monoclonal antibodies is Elotuzumab also attaches to made up of identical copies of one SLAMF7 on a type of immune cells type of antibody and recognises one called natural killer cells. This causes particular protein. the natural killer cells to attack myeloma cells. For more information see the Immunotherapy Horizons Infosheet How is elotuzumab given? from Myeloma UK Elotuzumab is given by intravenous infusion (into a vein). The usual dose How does elotuzumab work? is 10mg per kilogram of body weight Myeloma cells produce a protein once a week for the frst two cycles, called SLAMF7 which is present on then 10mg or 20mg per kilogram of the cell surface in large amounts. body weight, once every two or four Elotuzumab attaches to the SLAMF7 weeks, for the subsequent cycles. protein, enabling the immune Elotuzumab appears to be most system to target and destroy the effective against myeloma cells myeloma cells (Figure 1). when combined with other anti-myeloma treatments.

2 myeloma.org.uk What evidence exists to support and dexamethasone only). More the use of elotuzumab? patients initially responded to the The key clinical trials supporting elotuzumab combination (53 per the use of elotuzumab in relapsed 100, compared with 26 per 100 for and refractory myeloma with pomalidomide and dexamethasone). lenalidomide (Revlimid®) and In a separate clinical trial in newly pomalidomide (Imnovid®) were the diagnosed myeloma patients called ELOQUENT-2 and ELOQUENT-3 ELOQUENT-1, 371 patients were trials. given elotuzumab, lenalidomide In the ELOQUENT-2 clinical trial, 321 and dexamethasone, and 371 patients with relapsed or refractory patients were given lenalidomide myeloma were given elotuzumab, and dexamethasone only. In this trial lenalidomide and dexamethasone no difference was seen between (ERd), and 325 were given the two treatments in terms of lenalidomide and dexamethasone progression-free survival. only (Rd). In this trial, the average progression-free survival (meaning What are the possible known side time before the myeloma starts to effects of elotuzumab? come back) was longer for patients The most commonly observed side given ERd (19.4 months, compared effects of elotuzumab include: with 14.9 months for Rd). This Infusion reactions (reactions that difference was still seen after 4 • occur within three to four hours years, and the time the patients of receiving the intravenous eventually lived was also longer on infusion). Symptoms include fever, average for the ERd group. chills and changes in In the ELOQUENT-3 clinical trial, 60 blood pressure patients with relapsed or refractory Infections (including pneumonia) myeloma were given elotuzumab, • pomalidomide and dexamethasone, • Low white blood cell levels and 57 were given pomalidomide (leukopenia) and dexamethasone only. In this Deep vein thrombosis (blood clots trial, the average progression-free • in the veins) survival was longer for patients given the elotuzumab combination • Fatigue (10.3 months, compared with Diarrhoea 4.7 months for pomalidomide •

Infoline: 0800 980 3332 3 • Headache Before a drug can be widely used, it must ﬁrst be licensed as a safe and Cough • effective treatment. This is usually Because elotuzumab is a relatively done by regulatory authorities at a new drug, new side effects may European level and involves emerge which have not yet been a review of evidence from reported. large-scale clinical trials. Elotuzumab has been licensed by Is elotuzumab currently available the European Medicines Agency in any UK clinical trials? (EMA) for use in relapsed and refractory myeloma. The licence is For an up-to-date list of UK clinical for two combinations: elotuzumab, trials involving elotuzumab, visit the lenalidomide and dexamethasone; Myeloma Trial Finder on and elotuzumab, pomalidomide myeloma.org.uk and dexamethasone. To be enrolled on a clinical trial, Normally, the licensed drug must patients have to meet certain then be approved by a UK drug conditions known as eligibility appraisal body before it can be criteria. You should speak to your routinely prescribed by NHS doctors. doctor in the ﬁrst instance if you are The drug appraisal process differs interested in taking part in a trial. from licensing. It compares how If you are considering taking part in effective the newly-licensed drug is to a clinical trial your doctor will discuss existing drugs already in use on the in detail the risks and benefts for NHS and decides whether it offers the you. They will give you detailed NHS good value for money. information to enable you to make The main body responsible for an informed decision about whether carrying out drug appraisals to take part. in England and Wales is the National Institute for Health and Availability of Care Excellence (NICE). NICE elotuzumab in the UK recommendations are usually Elotuzumab is not currently available adopted in Northern Ireland. for use in myeloma in the UK and is Scotland’s drug appraisal body is only accessible to patients as part of the Scottish Medicines Consortium a clinical trial. (SMC).

4 myeloma.org.uk Elotuzumab has not been Key points submitted to NICE or the SMC for Elotuzumab is a drug that is being use in myeloma. Therefore it is not • investigated in the treatment of approved for use on the NHS in the myeloma UK. • Elotuzumab is a monoclonal Future directions antibody drug which targets the SLAMF7 protein found on the Elotuzumab continues to be studied surface of myeloma cells in different combinations and different myeloma patient groups. • Elotuzumab has been licensed This includes patients with relapsed for use in Europe in combination and/or refractory and newly with other anti-myeloma drugs for diagnosed myeloma. relapsed and refractory patients In addition to lenalidomide, • Elotuzumab is not yet widely pomalidomide and dexamethasone, available in the UK because it elotuzumab is also being studied has not been approved for use in in combination with treatments myeloma on the NHS. However, such as carflzomib (Kyprolis®) and patients may be treated with it as autologous stem cell transplantation. part of a clinical trial Other potential myeloma treatments • Side effects seen so far include targeting the same protein as infusion reaction, infections and elotuzumab (SLAMF7) are also low white blood cell levels being studied.

Infoline: 0800 980 3332 5 About this Infosheet Other information available The information in this Infosheet from Myeloma UK is not meant to replace the advice Myeloma UK has a range of of your medical team. They are the publications available covering all people to ask if you have questions aspects of myeloma, its treatment about your individual situation. and management. Download or For a list of references used to order them from develop our resources, visit myeloma.org.uk/publications myeloma.org.uk/references To talk to one of our Myeloma We value your feedback about our Information Specialists about patient information. any aspect of myeloma, call our For a short online survey go to Myeloma Infoline on 0800 980 3332 myeloma.org.uk/pifeedback or 1800 937 773 from Ireland. or email comments to The Infoline is open from Monday [email protected] to Friday, 9am to 5pm and is free to phone from anywhere in the UK and Ireland. Information and support about myeloma is also available around the clock at myeloma.org.uk

6 myeloma.org.uk Notes

Infoline: 0800 980 3332 7 Horizons Infosheet – Clinical trials and novel drugs: Elotuzumab (Empliciti®)

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Myeloma UK 22 Logie Mill, Beaverbank Business Park, Edinburgh EH7 4HG Published by: Myeloma UK 0131 557 3332 Publication date: November 2019 Last updated: November 2020 [email protected] Review date: May 2021 Registered Charity No: SC026116