PRESS RELEASE Embargoed until 14:00, Monday 10th November 2014
Newly diagnosed advanced melanoma patients in Scotland to benefit from Yervoy®T (ipilimumab) on the NHS
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Today’s decision paves the way for Scottish patients to have earlier access to innovative immuno‐ oncology therapy, which has shown potential to offer long‐term survival in some patients1 Ipilimumab works by stimulating the patient’s own immune system to recognise and fight cancerous cells2 and is one of the most significant treatment advances for this disease in many years
• Over the last 10 years, incidence rates of melanoma in Scotland have risen by 43% in males and 30% in females3 Uxbridge, Middlesex, 10 November 2014 – Bristol‐Myers Squibb has welcomed the news that the Scottish Medicines Consortium (SMC) today accepted the use of Yervoy®T (ipilimumab) for adult patients in Scotland with previously‐untreated (first‐line) advanced (unresectable or metastatic) melanoma. This decision means that eligible adult patients in Scotland will be able to routinely access ipilimumab without the need for prior treatment, which can include chemotherapy.4 Available data has shown ipilimumab 3mg/kg has the potential to improve the overall survival of some patients with unresectable or metastatic melanoma, irrespective of whether they have received prior therapy or not.1,5,6,7 Bristol‐Myers Squibb has worked closely with the SMC to secure a positive decision and is delighted that it has recognised the added value that this innovative treatment can offer to these patients, specifically in newly‐diagnosed cases of advanced melanoma. “Historically, advanced melanoma patients have had a poor prognosis in survival,” said Dr Marianne Nicolson, Consultant Medical Oncologist, Aberdeen Royal Infirmary. “It is vitally important that these patients are able to access quickly innovative treatment options that offer potential to maximise overall survival by using the body’s own immune system to fight the cancer. Ipilimumab was the first treatment option to offer some patients the potential of longer term survival in advanced melanoma. The positive SMC decision today is a significant step for patients in Scotland who are diagnosed with this difficult tumour.” 731UK14NP09805-01
Date of preparation: October 2014
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Ipilimumab is a fully human monoclonal antibody that works by stimulating the patient’s own immune system to recognise and fight cancerous cells within the body2 and is one of the most significant treatment advances for this disease in many years. In 2013, the SMC accepted ipilimumab for the treatment of adults with advanced melanoma who have received prior therapy.8 In November 2013, European regulators extended ipilimumab’s licence to include its use in adult patients as a first‐line treatment, recognising both its potential to significantly increase overall survival in some patients and the unmet need in this patient population. Commenting on the SMC’s recommendation, Leigh Smith, Chair of Melanoma Action and Support Scotland (MASScot), said “Melanoma is the most dangerous form of skin cancer and in 2012, over 1,100 patients in Scotland were diagnosed with the disease. Sadly, once it spreads, there are limited treatment options that can help to prolong the often young patients’ lives; therefore today’s SMC decision can be viewed as providing a new hope for patients in Scotland and their families.” Ipilimumab’s use in the first line setting in patients with advanced melanoma is supported by a pooled analysis of chemo‐naive patients who received ipilimumab 3mg/kg monotherapy in clinical trials and retrospective observational studies in patients treated with ipilimumab 3mg/kg monotherapy (studies CA184‐ 332 and CA184‐338).5,6,9 The safety profile of ipilimumab is comparable when it is used in the first or second line of treatment and is considered to be related to its mechanism of action as an immunotherapy.2 In a pivotal Phase III clinical trial, drug‐related adverse events related to the study drug were mostly immune‐related adverse events (irAEs).7 Immune related adverse events described to date have involved the gastrointestinal, skin, liver, endocrine, nervous systems and other organ systems.2 In the pivotal Phase III clinical trial, the most frequently reported adverse events (≥ 10% of patients) included diarrhoea, rash, pruritus, fatigue, nausea, vomiting, decreased appetite, and abdominal pain.2 The majority of side effects were mild to moderate;2 however more severe side effects have been reported and patients should be closely managed by their treating oncologist. In 2012, 1,177 patients in Scotland were diagnosed with malignant melanoma3 (the most dangerous form of skin cancer10), and a proportion of these patients will develop advanced (metastatic) disease. The incidence of melanoma in Scotland is rising and over the last 10 years, it has risen by 43% in males and 30% in females.3 Tragically, melanoma affects a disproportionately high number of young people 731UK14NP09805-01
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and each day more than two young adults in the UK are diagnosed with malignant melanoma.11 Advanced (metastatic) melanoma (cancer that has spread to another part of the body12) is a terminal disease, and while survival estimates are changing, it has previously been linked with a median overall survival of just 6‐9 months.13 Commenting on the decision, Johanna Mercier, General Manager, Bristol‐Myers Squibb UK & Ireland, said, “As the first immuno‐oncology therapy, ipilimumab offers an important innovative treatment option for advanced melanoma patients. Bristol‐Myers Squibb is pleased with the decision by the SMC to acknowledge the value and clinical unmet need in this patient population, recognising ipilimumab as the first therapy to be associated with an increase in overall survival for some patients. Bristol‐Myers Squibb remains committed on furthering outcomes for patients in melanoma and leading advances in the area of immuno‐oncology.” ‐ ENDS ‐ NOTES TO EDITORS About Yervoy®T (ipilimumab) Ipilimumab is a fully human monoclonal antibody that works by stimulating the body’s own immune system to fight cancer. Its mechanism of action in patients with melanoma is indirect, possibly through T‐cell mediated anti‐tumour immune responses.2 In July 2011, ipilimumab received a European licence for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy.14 Ipilimumab is now licensed in more than 40 countries in this setting. In November 2013, ipilimumab was granted an extension to its licence to include its use as a treatment for advanced (unresectable or metastatic) melanoma in adults who have not yet received prior therapy.2 Ipilimumab data in melanoma Ipilimumab’s use in previously‐untreated (first line) patients with advanced melanoma is supported by a pooled analysis of chemo‐naive patients who received ipilimumab 3mg/kg monotherapy in clinical trials and retrospective observational studies in patients who were treated with ipilimumab 3mg/kg monotherapy (studies CA184‐ 332 and CA184‐338).5,6,9 In previously‐treated (second line) advanced melanoma, ipilimumab has been shown to provide long‐ term survival in some patients.1 Ipilimumab became the first treatment to demonstrate an overall survival benefit in a Phase III clinical trial in this patient population.7 In the pivotal Phase III clinical trial 731UK14NP09805-01
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assessing ipilimumab in previously‐treated (second line) patients, published in the New England Journal of Medicine in 2010, a secondary endpoint observed that 46% of patients were still alive at one year in the ipilimumab arm and 25% in the comparator, a vaccine called gp100. The median overall survival was 10.1 months among patients receiving ipilimumab alone, compared to 6.4 months among patients receiving gp100 alone.7
Available data have demonstrated that, as monotherapy at this 3mg/kg dose, treatment with ipilimumab has the potential to improve the overall survival of some patients, irrespective of whether they have received prior therapy or not for their metastatic melanoma.1,5,6,7 The safety profile of ipilimumab in previously‐untreated (first line) patients is comparable to that seen in those who have been previously‐treated (second line).2
Safety information on ipilimumab2 The safety profile of ipilimumab is considered to be related to its mechanism of action as an immunotherapy. In a pivotal Phase III clinical trial, drug‐related adverse events related to the study drug were mostly immune‐related adverse events (irAEs).7 Immune‐related adverse events described to date have included gastrointestinal, skin, liver, endocrine, nervous systems or other organ systems. In the pivotal Phase III clinical trial, the most frequently reported adverse events (≥ 10% of patients) included diarrhoea, rash, pruritus, fatigue, nausea, vomiting, decreased appetite, and abdominal pain. The majority were mild to moderate. The safety profile of ipilimumab in previously‐untreated (first line) patients is comparable to that seen in those who have been previously‐treated (second line). Early diagnosis and appropriate management of adverse events using established product‐specific guidelines are essential to minimise complications. The full Summary of Product Characteristics for ipilimumab can be found online at: http://www.medicines.org.uk/emc/medicine/24779/SPC/YERVOY+5+mg+ml+concentrate+for+solution+ for+infusion/ About Bristol‐Myers Squibb Bristol‐Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For further information or to speak to a UK spokesperson, please contact: Bristol‐Myers Squibb: RM Eclipse Mark Reale Tim Cockroft Office: 01895 523 627 Office: 020 7861 2805 Mobile: 07581 31 3040 Mobile: 07957 325 583 Email:
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Date of preparation: October 2014
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Schadendorf D et al. Pooled analysis of long‐term survival data from phase II and phase III trials of ipilimumab in metastatic or locally advanced, unresectable melanoma. Abstract # 24LBA, presented at the European Cancer Congress 2013 2 Yervoy Summary of Product Characteristics. Current version is available at: http://www.medicines.org.uk/EMC/searchresults.aspx?term=yervoy&searchtype=QuickSearch Last accessed: October 2014 3 National Services Scotland. Cancer in Scotland (April 2014). Available at: https://isdscotland.scot.nhs.uk/Health‐ Topics/Cancer/Publications/2014‐04‐29/Cancer_in_Scotland_summary_m.pdf Last accessed October 2014 4 Scottish Medicines Consortium. Yervoy (ipilimumab) for the treatment of advanced (unresectable or metastatic) melanoma in adults. 5 Margolin K, et al. Effectiveness and safety of first‐line ipilimumab 3 mg/kg therapy for advanced melanoma: Evidence from a U.S. multisite retrospective chart review. ECCO/ESMO 2013 Abstract #3742 6 Patt D, et al. A community‐based, real‐world, study of treatment‐naive advanced melanoma (AM) patients treated with 3mg/kg ipilimumab (IPI) in the United States. European Cancer Congress; Amsterdam, Netherlands September 27 ‐ October 1 2013, Poster 3.751 7 Hodi FS et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010; 363:711‐23 8 Scottish Medicines Consortium. Yervoy (ipilimumab) for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy. Available at: https://www.scottishmedicines.org.uk/files/advice/ipilimumab_Yervoy_RESUBMISSION_FINAL_March_2013_for_website.pd f Last accessed October 2014 9 Dummer et al. Overall survival of chemotherapy‐naive patients with advanced melanoma treated with ipilimumab 3mg/kg in clinical trials. Poster presented at the Melanoma Bridge Congress, Naples, Italy 5‐8 December 2013 10 Skin Cancer Foundation. Melanoma. Available at: http://www.skincancer.org/skin‐cancer‐information/melanoma. Last accessed October 2014 11 Cancer Research UK. Skin cancer – Key facts. Available at: http://www.cancerresearchuk.org/cancer‐ info/cancerstats/keyfacts/skin‐cancer/ Last accessed October 2014 12 Cancer Research UK. Advanced melanoma (stage 4). Available at: http://www.cancerresearchuk.org/about‐ cancer/type/melanoma/treatment/advanced‐melanoma Last accessed October 2014 13 Larkin J, Gore M. Malignant Melanoma (metastatic). Clinical Evidence (online) 2008 pii.1718 14 EMA website. Assessment Report for Yervoy (ipilimumab) ‐ May 2011. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_‐ _Public_assessment_report/human/002213/WC500109302.pdf last accessed May 2014
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