READING, UK ? 15th OCTOBER 2020 ? The National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending Sarclisa? (isatuximab), in combination with existing treatment (pomalidomide and dexamethasone, or pom-dex), for adults with relapsed/refractory* multiple myeloma (RRMM) who have received three prior lines of treatment and at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last treatment. 1 This recommendation has been welcomed by both the patient and medical communities at a time when cancer patients, one of the most vulnerable groups, are facing a marked impact due to the global COVID-19 pandemic, with delays in treatment and services. ?We?re delighted that NICE has recommended isatuximab. Myeloma remains incurable and is a hugely challenging cancer to live with. It is vital for patients to know that treatments are there waiting for them when they relapse,? said Laura Kerby, CEO, Myeloma UK. ?The limited therapies available for patients at later stages of the disease mean that increasing options at this point in the treatment pathway is crucial. Having access to a treatment that can provide valuable extra months without disease progression offers hope that people will have more time with their loved ones.? Date of preparation: October 2020 Document number: MAT-GB-2002766 (v1.0) An estimated 5,700 people in the UK are diagnosed with multiple myeloma each year, the equivalent to 15 people each day. 4 There are approximately 3,000 multiple myeloma related deaths each year, with almost half of patients dying within five years of diagnosis. 4 Multiple myeloma patients experience frequent relapses and the cancer can become resistant to available treatments, making it much harder to control.5 ?Despite a growing understanding of multiple myeloma, it still remains incurable and carries a significant disease burden among the older adult patient population,? said Professor Kwee Yong, Consultant in Haematology, University College Hospital, London. ?Trials have shown that isatuximab, in combination with pomalidomide and dexamethasone, offers a significant advantage over treatments which were ? until now ? considered the standard of care for adults with relapsed and refractory multiple myeloma. Today?s recommendation, therefore, provides us with an urgently needed new therapeutic option for this group of hard-to-treat patients, for whom life expectancy and prognosis is poor.? The ICARIA-MM trial demonstrated that isatuximab in combination with pomalidomide and dexamethasone showed a reduction in risk of disease progression or death in adults by 40%, potentially extending the length of time a patient can live without their cancer progressing (progression-free survival) to 11.5 months, compared to 6.5 months when treated with pomalidomide and dexamethasone alone (HR 0.596 95% CI 0.44-0.81 P=0.001). 2 Overall, isatuximab showed an additional 5.0 months without disease progression. 2 Isatuximab was the first treatment in multiple myeloma to be awarded a Promising Innovative Medicine designation and made available before approval via the Early Access to Medicine Scheme (EAMS). The addition of isatuximab to pomalidomide and dexamethasone was well tolerated with no increase in treatment discontinuation or incidence of fatal events compared with that in the pomalidomide and dexamethasone group.2 Sanofi is proud that through working with NICE, NHS England and the Cancer Drugs Fund, eligible patients can now benefit from this treatment. ?At Sanofi Genzyme we are driven by all the loved ones taken by cancer, and all those still facing it. We believe everyone affected by cancer deserve more ? more options, more support and more life,? said Nicole Farmer, General Manager, UK & Ireland, Sanofi Genzyme. ?We are therefore delighted at the recognition and recommendation from NICE, meaning we are able to make a new treatment option accessible to patients, offering a chance to delay disease progression.? About ICARIA-MM The NICE FAD is based on a cohort of patients from the pivotal ICARIA-MM trial who received three prior lines of anti-myeloma treatment, including lenalidomide and a proteasome inhibitor.2 ICARIA-MM is the first randomised Phase 3 trial to report results evaluating an anti-CD38/pomalidomide/dexamethasone combination. It was an openlabel, multi-centre trial evaluating isatuximab in combination with pom-dex versus pomdex alone in patients with RRMM.2 The study enrolled 307 patients with RRMM across 102 hospitals spanning 24 countries, including sites in the UK. 2 Date of preparation: October 2020 Document number: MAT-GB-2002766 (v1.0) About isatuximab Isatuximab is a monoclonal antibody (also known as a mAb) that binds to a specific site on a protein called CD38, a high amount of which is present on the surface of MM cells. By binding to the CD38 protein, isatuximab helps the body?s immune system target and destroy the cancerous cell.2 Isatuximab is the first monoclonal antibody therapy approved in Europe to be used in combination with pom-dex for the treatment of RRMM. It was granted Marketing Authorisation in the European Union on 30 May 2020.6 About Sanofi Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 employees in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Sanofi, Empowering Life. Media Relations Contact Claire Whitmarsh Sanofi UK & Ireland Tel.: 07935 503 416 claire.whitmarsh@sanofi.com Adverse events Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.giv.uk. Adverse events should also be reported to Sanofi. Opening office hours: 09.00 - 17.00 (Monday to Thursday) 09.00 - 16.00 (Friday) Tel.: +44 (0) 800 090 2314. Alternatively, send via email to UK-drugsafety@sanofi.com References 1 NICE. Final appraisal document. Isatuximab with pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma. October 2020 2 Attal M, Richardson PG, et al. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096?2107. 3 Myeloma UK. Infopack for newly diagnosed myeloma. Available at: https://www.myeloma.org.uk/wpcontent/uploads/2018/05/Myeloma-UK-Infopack-for-newly-diagnosed-myeloma-patients.pdf. Accessed October 2020. Date of preparation: October 2020 Document number: MAT-GB-2002766 (v1.0) 4 Myeloma UK Impact report, July 2018. Available at: https://www.myeloma.org.uk/wpcontent/uploads/2018/10/Myeloma-UK-Impact-Report-2018.pdf. Accessed October 2020. 5 Infopack for relapsed and/or refractory myeloma patients. Myeloma UK. Available at: https://www.myeloma.org.uk/wp-content/uploads/2018/05/Myeloma-UK-Infopack-for-relapsed_refractorymyelomapatients.pdf. Accessed October 2020. 6 European Medicines Agency. Sarclisa. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/sarclisa. Accessed October 2020