News

by Simon Rodwell | 20 September 2012 10:34

News stories on this page

Melanoma treatments: new drug combo restrictions lifted
Melanoma World Society Newsletters
NICE approves combination immunotherapy treatment for melanoma
NCRI seeking new patient representatives for its Skin Clinical Studies Group
Patient Impact Programme award to Newcastle University for melanoma ulceration study
Review of smartphone melanoma apps recommends caution
Survey finds the public are confused by sunscreen labelling
NCRI and Melanoma Focus appeal for continued support for combination therapy
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Early Access to Medicines scientific opinion issued for pembrolizumab
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Melanoma Focus guidelines for uveal melanoma accredited by NICE
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Encouraging results announced for new immunotherapy drug pembrolizumab
Follow-up of high risk cutaneous melanoma cases: key paper released
Sunbeds: an ASA Ruling

NHS England has now removed restrictions on access for patients to certain therapies used in combination following a consultation process involving specialist melanoma oncologists led by Melanoma Focus Trustee Dr Pippa Corrie. The combinations are dabrafenib + trametinib, which is suitable for patients with a BRAF mutation, and the immunotherapy drugs ipilimumab + nivolumab. Click here for a full description of what has changed.

We now provide links and contents lists for this new series of excellent newsletters that review recently-published papers on all aspects of melanoma medicine. Click here to visit our Library page.

The National Institute for Health and Care Excellence (NICE) has approved a combination therapy for melanoma patients in England and Wales. This means they will be the first in Europe who can be prescribed this treatment. The decision was made in record time and is expected to apply in due course throughout the United Kingdom.

Dr Paul Nathan, a consultant medical oncologist and Melanoma Focus Trustee, commented: ‘Immunotherapy is genuinely exciting, it is starting to have a profound effect on many cancers and I’m in no doubt there will be patients that have long-term durable control of their disease. It really is a game-changer.’

The drugs, nivolumab and ipilimumab, will be combined in a new therapy for people with metastatic melanoma (or disease that has spread to organs of the body beyond the skin).

Professor Peter Johnson, Cancer Research UK’s chief clinician, said: ‘These results give new hope to melanoma patients. But it’s important to remember that more powerful treatment comes with an increased chance of severe side effects. Our research now needs to identify which patients are most likely to benefit from this combination and who is most likely to experience the side effects, so doctors can make sure we get the balance right.’

NICE’s Professor Carole Longson said: ‘After one of the fastest drug appraisals NICE has carried out, these promising new immunotherapy treatments for advanced melanoma look set to significantly extend the life of people with the condition. The evidence we examined was very promising and I know further trials are ongoing which have also released encouraging data.’

Click here to read more.

The National Cancer Research Institute (NCRI) is seeking to recruit new consumers – or patient representatives – affected by cancer to join its Clinical Studies Groups (CSGs), including the Skin CSG. CSGs meet at least twice a year and consumer members participate in all aspects of the Group’s activities. They also have membership of the NCRI Consumer Forum.

Apart from the Skin CSG, NCRI is also seeking patient representatives for its Head & Neck, Prostate, Teenage & Young Adults and Upper GI CSGs. For further information and details of how to apply please click here.

Melanoma Focus has awarded funds to a scientific group based at Newcastle University to investigate the phenomenon of the ulceration of skin above a melanoma and the associated greater risk of the disease spreading to other parts of the body. The project, Validation of Ambra-1 and Loricrin as prognostic biomarkers for the early detection of high risk melanomas, will be conducted over 18 months under the direction of Dr Rob Ellis and Professor Penny Lovat and will concentrate on the role of two proteins found in the layer of skin overlying melanomas. The findings will help to predict which patients are at a higher risk of metastatic melanoma and therefore require closer follow-up, as well as investigating more effective therapies to reduce the rate of metastasis and overall mortality.

Click here for more information about the award… and here for a technical overview.

A recent study of smartphone applications (‘apps’) designed to be used by non-specialists in the detection or prevention of melanoma has urged users to be cautious. The review, published in the July 2015 edition of The British Journal of Dermatology, was the work of a team led by Dr Fiona Walter from the University of Cambridge’s Department of Public Health and Primary Care. It is the most comprehensive research finding of its type.

Dr Walter said: ‘Although smartphone apps are recognized as having potentially wide use in detecting melanoma, experts have expressed caution concerning their usefulness, accuracy and safety. We identified almost 40 apps available to detect or prevent melanoma by non-specialist users – patients and GPs.

‘Most apps gave advice or education about melanoma, ultraviolet radiation exposure preventive advice and skin self-examination strategies. Only half of them enabled patients to capture and store images of their skin lesions, either for review by a dermatologist or for self-monitoring to identify change – an important predictor of melanoma. A small minority (4) provided a risk assessment about a skin lesion.

‘In summary, there was little evidence of any evaluation of their usefulness or accuracy, so clinicians and patients alike should be cautious about using these apps to detect melanoma’.

Click here to see the article.

A survey by The Royal Pharmaceutical Society (RPS) has found that the public is confused about the labelling of sun creams, calling for a standardised rating method by all manufacturers.

Professor Jayne Lawrence, Chief Scientist of the RPS, said: ‘This survey indicates that there is a huge amount of confusion around sunscreen labelling that is a barrier to effective sun protection. Clearly many consumers do not realise the SPF rating applies only to the amount of protection offered against UVB rays, not UVA rays – both of which can damage the skin and cause skin cancer.

‘People should not have to pick their way through complicated dual ratings information to understand how sunscreen works and the amount of protection it potentially provides. We think it’s time for sunscreen manufacturers to provide one easy to understand rating, based on a simple description of the total amount of sun protection offered: low, medium, high and very high protection.

‘People now have largely got the message that they must protect their skin from the sun using sunscreen, along with other precautions such as covering up and keeping out of the sun during the hottest part of the day. What the RPS is calling for now is one uniform measure for all sun protection products, so pharmacists can provide easy to understand advice on the effectiveness of products and how they should be used’.

Of the 2,000 UK adults who were surveyed only one in five was aware that the SPF rating relates to protection against UVB rays, rather than against UVA radiation. There is the possibility that overexposure to UVA or UVB radiation may lead to melanoma.

Melanoma specialists from Melanoma Focus and the Skin Cancer Clinical Studies Group (CSG), a clinician/patient group operated by the National Cancer Research Network, have been seeking to persuade NHS England to continue to allow the use of a combination BRAF/MEK inhibitor therapy for the treatment of advanced melanoma. However a recent decision by NHS England has ruled against further support for the treatment concerned. Meanwhile an initiative by the manufacturer of the drugs involved may mean there is hope that this treatment will be available in the future.

Background

In 2014 the results of three large randomised trials were published, comparing the combination of a BRAF and a MEK inhibitor against the benefits of a single BRAF inhibitor used alone. The studies showed that combining these two types of drugs is more effective in prolonging patient survival than using either of two available BRAF inhibitors, vemurafenib or dabrafenib, on their own. The combination therapy is unlicensed in Europe.

In November 2014 NICE approved the use of dabrafenib treatment for advanced melanoma and until January 2015 clinicians in the UK were able to prescribe this combination of treatments types as the result of a programme by GlaxoSmithKline (GSK) to supply both drugs (dabrafenib and trametinib) free of charge.

NHS England’s Ruling

In December 2014 NHS England decided that dabrafenib could be funded only as a stand-alone treatment (‘monotherapy’) rather than in combination with trametinib. The Skin Cancer CSG and Melanoma Focus appealed against this decision but their arguments were not successful: NHS England stated they were concerned about the financial implications and ruled that continuing to prescribe dabrafenib in combination with trametinib, even though the trametinib would be supplied free of charge, would require a formal application to the Cancer Drugs Fund (CDF). This would involve a full analysis of the economic implications.

However Novartis (the pharmaceutical company that has taken over responsibility for dabrafenib and trametinib from GSK) may make an application to the CDF later in 2015 for the funding of this drug combination.

Guidance for Clinicians and Patients

In the meantime clinicians are being advised to consider offering their patients, where appropriate, the opportunity of taking part in COLUMBUS, a global clinical trial approved in the UK trial involving combination therapies.

Further Information

Professional Members of Melanoma Focus who wish to study the various documents arising from the joint CSG/MF approach to NHS England – including a fuller account of the background to this story, written by Dr Paul Lorigan (Chair, Melanoma Focus) and Dr Pippa Corrie (Chair, Skin Cancer CSG, NCRN & Trustee, Melanoma Focus) – should follow this link to a password-protected page in the Members’ Area.

Click here for Lay Summary: Superiority of BRAF+MEK inhibition vs. BRAF inhibition alone

The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued its first Early Access to Medicines (EAMS) scientific opinion, for the drug pembrolizumab (also known as MK-3475). This is used to treat advanced melanoma that has spread or cannot be removed by surgery and has progressed after other treatments. The MHRA assessment team considered that pembrolizumab had been shown to slow the progression of cancer in a condition where other treatments currently have poor results.

Specifically, the assessors noted: ‘Amongst the 173 patients who had failed previous therapies, a shrinking of their tumour was observed in 24% and the progression of the disease was halted in 47% for a durable period of time. Approximately 60% of patients survived for at least one year’.

However they also described some risks: ‘Pembrolizumab may be associated with side effects resulting from excessive activity of the immune system. Most will resolve following appropriate treatment or on stopping pembrolizumab. The most frequent side effects, affecting at least 20% of the patients, were fatigue (tiredness), cough, nausea (feeling sick), rash, pruritus (itching), decreased appetite, constipation, joint pain, and diarrhoea’.

The aim of the EAMS scheme is ‘to provide earlier availability of promising new unlicensed medicines to UK patients that have a high unmet clinical need. The MHRA scientific opinion provides benefit and risk information to doctors who may wish to prescribe the unlicensed medicine under their own responsibility’.

Further details of the scientific opinion can be found on the MHRA website. Follow this link for background information on EAMS.

Melanoma Focus has announced that its recently-completed national guidelines for uveal (ocular) melanoma have been awarded formal accreditation by The National Institute for Health and Care Excellence (NICE).

Melanoma Focus has funded the project. The guidelines were developed over the past three years by the group of experts, aided by patient representatives. The result is a comprehensive set of recommendations, based on the best available scientific evidence. It is expected to enhance patient care and improve counselling and informed decision-making, while helping clinicians gain a better understanding of outcomes.

For further details click here

A highly anticipated new immunotherapy from Merck & Co Inc proved effective in patients with advanced melanoma as well as some with lung cancer or head and neck cancer, according to early-stage studies presented on Monday… a Phase I study in 411 patients with melanoma that had spread to other parts of the body found that 69 percent were alive after a year of treatment. At 18 months, researchers estimated that overall survival was 62 percent, with some patients on the drug for more than two years. The findings were presented at the American Society of Clinical Oncology meeting in Chicago. (Reuters)

Click here to see the report in full

Following the recent remarkable progress in improving the treatments available for those suffering from advanced melanoma, almost 50 of the UK’s leading melanoma clinicians have reached a consensus view on the how to follow up patients believed to be at a high risk of the disease recurring.

The report’s lead author, Dr James Larkin of The Royal Marsden, said: ‘Our findings represent a significant departure from the previous guidelines, which were published in 2010. They are intended as a framework for clinical teams treating patients with melanoma. But this is a dynamic field of medicine and we expect there to be some debate over these recommendations.’

Read more about this story via this link

Incensed by the extraordinary claims in a sunbed salon’s advertising about the potential health benefits of tanning, John Rouse (an adviser to Melanoma Focus) entered battle. He anticipated having to use expert witnesses to counter the salon’s assertions but in the event the Advertising Standards Authority ruled they contravened the regulation that only products licensed for medicinal purposes may claim such benefits.

Follow this link to read John’s account in full.

Have you seen a salon near you making exorbitant claims about the ‘benefits’ of sunbeds? If so, let us know: info@melanomafocus.com

 

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