Date of preparation, May 2014 ONCUK14NP05231‐01 PRESS RELEASE EMBARGOED UNTIL 00:01 13th JUNE, 2014 NICE says ‘Yes’ to Yervoy®T (ipilimumab), allowing access for NHS patients with previously‐untreated advanced melanoma •
Decision paves the way for earlier access to this innovative medicine, which has previously shown potential to offer long‐term survival in some patients1 •
Today’s announcement represents a landmark decision by NICE and a demonstration of its support of medical innovation Ipilimumab works by stimulating the patient’s own immune system to fight the cancer2 and is one of the most significant treatment advances for this disease in many years Historically, advanced melanoma has been associated with a median survival of just 6‐9 months.3 Each day more than two young adults aged 15‐34 in the UK are diagnosed with malignant melanoma4 •
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UXBRIDGE, UK, 13 June, 2014 – Bristol‐Myers Squibb today welcomed the decision by the National Institute for Health and Care Excellence (NICE) to recommend Yervoy®T (ipilimumab) for adult patients with previously‐untreated (first line) advanced (unresectable or metastatic) melanoma within its Final Appraisal Determination (FAD). This landmark decision will enable NHS patients in England and Wales to routinely access ipilimumab without the need for prior treatment, which can include chemotherapy.5 The decision by NICE follows a draft recommendation, issued in February 2014, which restricted the use of ipilimumab in previously‐
untreated patients to clinical trials only. Bristol‐Myers Squibb has worked closely with NICE following that recommendation and today’s announcement underscores the Institute’s commitment to supporting medical innovation in an area of significant unmet medical need. “Today’s decision is very welcome news for patients and marks a major milestone in the treatment of advanced melanoma in the UK,” said Professor John Wagstaff, Consultant Oncologist at the South West Wales Cancer Institute & Swansea School of Medicine. “Ipilimumab has shown the potential to offer long term survival in some patients and the decision to make this innovative 2
immuno‐oncology treatment available to all advanced melanoma patients should therefore be viewed as a significant step in maximising the potential for survival in this difficult‐to‐treat disease.” Ipilimumab is a fully human monoclonal antibody that works by stimulating the patient’s own immune system to fight the cancer2 and is one of the most significant treatment advances for this disease in many years. In 2012, NICE recommended ipilimumab for the treatment of adults with previously‐treated (second line) advanced melanoma.6 In November 2013, European regulators extended ipilimumab’s licence to include use in previously‐untreated (first line) patients, recognising both its potential to significantly increase overall survival and the unmet need in this patient population. Commenting on NICE’s recommendation, Gill Nuttall, Melanoma UK said: “Today’s recommendation by NICE is hugely welcome news and will make a much‐needed option for advanced melanoma patients more widely available in the UK. We are pleased that patients can now have access to ipilimumab earlier in the treatment of their disease.” Ipilimumab’s use in previously‐untreated (first line) patients with advanced melanoma is supported by retrospective observational studies in patients who were treated with ipilimumab 3mg/kg monotherapy (studies CA184‐ 332 and CA184‐338).7,8 Available data have also demonstrated that, as monotherapy at this 3mg/kg dose, treatment with ipilimumab has the potential to improve the overall survival of patients, irrespective of whether they have received prior therapy or not for their metastatic melanoma.1,7,8,9 The safety profile of ipilimumab in previously‐untreated (first line) patients is also comparable to that seen in those who have been previously‐treated (second line).2 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).9 Immune‐
related adverse events described to date have included gastrointestinal, skin, liver, endocrine or nervous systems. 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.9 2
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Around 13,300 people in the UK were diagnosed with melanoma in 2011 and, although the majority of skin cancers are treatable, in 2011 this disease killed around 2,200 people in the UK.4 Each day more than two young adults aged 15‐34 in the UK are diagnosed with malignant melanoma.4 Over the last 30 years, the incidence of melanoma in the UK has risen faster than any of the current top‐10 cancers.4 While recent treatment advances are improving outcomes, historically advanced melanoma has been associated with a median survival of just 6‐9 months.3 Commenting on today’s decision, Johanna Mercier, General Manager, Bristol‐Myers Squibb UK & Ireland, said “As an immuno‐oncology therapy, ipilimumab offers an important treatment option for patients with advanced melanoma. Bristol‐Myers Squibb is pleased with the decision by NICE and with its resolve to work with us to address this significant unmet medical need in the UK. We remain focused on further improving outcomes in melanoma and are committed to continuing to lead advances in immuno‐oncology, with a goal of changing survival expectations and the way patients live with cancer.” 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.10 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 retrospective observational studies in patients who were treated with ipilimumab 3mg/kg monotherapy (studies CA184‐ 332 and CA184‐338).7,8 3
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In previously‐treated (second line) advanced melanoma, ipilimumab has been shown to provide long‐term survival in some patients.1 Upon its approval in 2011, it became the first treatment to demonstrate an overall survival benefit in a Phase III clinical trial in this patient population. In the pivotal Phase III clinical trial assessing ipilimumab in previously‐treated (second line) patients, published in the New England Journal of Medicine in 2010, 46% (63 people out of 137) of patients were still alive at one year in the ipilimumab arm and 25% (34 people out of 136) 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.9 Available data have demonstrated that, as monotherapy at this 3mg/kg dose, treatment with ipilimumab has the potential to improve the overall survival of patients, irrespective of whether they have received prior therapy or not for their metastatic melanoma.1,7,8,9 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).9 Immune‐related adverse events described to date have included gastrointestinal, skin, liver, endocrine or nervous systems. 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.9 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+sol
ution+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. 4
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For more information, please contact: Louise Otterburn‐Sawyer RM Eclipse T: +44 (0)207 861 2821 M: +44 (0)7795 342983 E: [email protected] Mark Reale Head of UK Communications Bristol‐Myers Squibb UK T: +44 (0)1895 523 627 M: +44 7581 068092 E: [email protected] ### REFERENCES 1 – 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 (accessed: January 2014) 3 – Larkin J, Gore M. Malignant Melanoma (metastatic). Clinical Evidence 2008; 08; 1718 4 – Cancer Research UK. Skin cancer – Key facts. Available at: http://www.cancerresearchuk.org/cancerinfo/cancerstats/keyfacts/skin-cancer/ (accessed January 2014) 5 – NICE Final Appraisal Determination – ipilimumab in previously‐untreated (unresectable or metastatic) melanoma. 6 – NICE Guidance TA268. Available at: http://guidance.nice.org.uk/TA268 (accessed February 2014) 7 ‐ 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 8 – 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 9 – Hodi FS et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010; 363:711‐23 10 – EMA website. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_‐
_Public_assessment_report/human/002213/WC500109302.pdf last accessed May 2014 5