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NICE Recommends MSD's KEYTRUDA® (pembrolizumab) for Use Within the Cancer Drugs Fund as Monotherapy for the Adjuvant Treatment of Adults with Stage III Melanoma with Lymph Node Involvement Who Have Undergone Complete Resection

MSD
Posted on: 18 Dec 18

NICE Recommends MSD's KEYTRUDA® (pembrolizumab) for Use Within the Cancer Drugs Fund as Monotherapy for the Adjuvant Treatment of Adults with Stage III Melanoma with Lymph Node Involvement Who Have Undergone Complete Resection1

Hoddesdon, December 17, 2018 - Today, MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK)) is pleased to announce that National Institute of Care and Health Excellence (NICE) has issued guidance that recommends KEYTRUDA® (pembrolizumab) for use within the Cancer Drugs Fund as monotherapy for the adjuvant treatment of adults with stage III melanoma with lymph node involvement who have undergone complete resection. It is recommended only if the conditions in the managed access agreement for pembrolizumab are followed.[i]

This approval is a milestone for a patient population where the current standard of care is routine surveillance (‘watch and wait’).1 The approval is based on data from the EORTC1325/KEYNOTE-054 trial, published in the New England Journal of Medicine in 2018. The data found that at median follow-up of 15 months, pembrolizumab was associated with significantly longer recurrence-free survival than placebo (1-year rate of recurrence-free survival in the overall intention-to-treat population – 75.4% vs. 61.0% (HR = 0.57 (p<0.001)) – and in a subgroup of patients with PD-L1-positive tumours – 77.1% vs. 62.6% (HR = 0.54 (p<0.001)).[ii]

Melanoma has a substantial effect on patients, their carers and the wider society. Five-year survival estimates are about 50% to 55% for stage III disease.1 People with fully resected stage III melanoma are still at high risk of disease recurrence, with 5 year relapse-free survival of 28% to 44%.1 There are around 15,400 new melanoma skin cancer cases every year in the UK, that's 42 every day (2013 – 2015).[iii]

“The introduction of this new stage in treatment brings about a shift in the mindset for treating melanoma long term. Historically, Stage III patients have been obliged to ‘watch and wait’ for advanced progression. A solution that has been a burden psychologically for many patients and their families,” said Imogen Cheese, Director, Melanoma Patient Conference CIC. “Offering pembrolizumab for a year is a positive step forward in long term care plans. As treatment options continue to improve, the patient community look to pharmaceutical companies and our medical professionals to continuously work together, developing solutions that suit our evolving needs.”

Dr Sophie Papa, Senior Lecturer and Honorary Consultant Medical Oncologist, King's College London and Guy's and St Thomas' NHS Foundation Trust: “Pembrolizumab for the treatment of surgically removed stage III melanoma has the potential to prevent recurrence of the disease, according to results from the Keynote-054 study. The decision by NICE to introduce pembrolizumab to our clinical options for this patient population through the cancer drugs fund (CDF) is a fantastic step forward. The focus on collecting NHS relevant clinical data through the CDF helps us access treatment now for patients. It also ensures that we continue to properly define the impact of this adjuvant treatment on preventing relapse of disease and, crucially, death from melanoma going forward.”

 “This is great news as stage III melanoma patients currently have limited treatment options available following surgery”, said Delia Sworm, Macmillan Clinical Nurse Specialist – Skin Cancer, The British Association of Skin Cancer Specialist Nurses (BASCSN). “This decision by NICE is a huge step forward in the management of melanoma”.

Gillian Nuttall, Melanoma UK: “The number of people with melanoma in the UK is continuing to rise, especially in younger people. The current ‘watch and wait’ approach after surgery can be a tense time for patients and their families, making this announcement even more important as we can begin to shift away from this. This is encouraging news for the patient population.”

Inclusion in the CDF shows that NICE considers pembrolizumab has potential to satisfy the criteria for routine use on the NHS for this group of melanoma patients but needs more investigation, through data collection in the NHS, before making a final decision on routine commissioning. The CDF has been set up to allow NHS patients in England faster access to the most promising new cancer treatments.[iv] MSD has worked collaboratively with NHS England and NICE to ensure eligible patients have access to treatment as soon as market authorisation is achieved.

Louise Houson, Managing Director, MSD UK and Ireland said “Melanoma remains an area of great importance for MSD. We look forward to combining vital science research in our laboratories with the work of healthcare professionals in the UK so that, together, we can renew our efforts to reach the best possible outcomes for everyone affected by melanoma. We will continue to work with the Cancer Drugs Fund so that patients can continue to access pembrolizumab whilst we continue to build our knowledge of its longer-term outcomes for patients.”

###

Notes to editors:

About Melanoma

Melanoma is the most serious form of skin cancer and is characterized by the uncontrolled growth of pigment-producing cells.[v] It is the 5th most common cancer in the UK, accounting for 4% of all new cancer cases.3 Melanoma skin cancer incidence rates are projected to rise by 7% in the UK between 2014 and 2035, to 32 cases per 100,000 people by 2035.3 Around 1 in 10 melanoma skin cancer cases are diagnosed at a late stage in England. 3

Stage III melanoma means that the melanoma cells have spread into skin, lymph vessels, or lymph glands close to melanoma.[vi] Stage III melanomas are considered intermediate to high risk as they more likely to spread to other parts of the body (stage IV melanoma) than in earlier stages of the disease.[vii]

About EORTC8

European Organisation for Research and Treatment of Cancer (EORTC) conducts clinical research in cancer, looks for new impactful new solutions and places patients at the centre of their programmes. EORTC manages clinical research activities across 35 countries.[viii] Through translational and clinical research, EORTC offers an integrated approach to therapeutic strategies, drug evaluation programs, outcomes research and quality of life. For more information, visit www.eortc.org.

 

 

 

About KEYNOTE-0542

            Findings from KEYNOTE-054 which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC) showed that pembrolizumab was associated with significantly longer recurrence-free survival as adjuvant therapy in patients with resected, high risk stage III melanoma, compared to placebo at a median follow up of 15 months (1-year rate of recurrence-free survival, 75.4% [95% confidence interval {CI}, 71.3 to 78.9] vs.61.0% [95% CI, 56.5 to 65.1]; hazard ratio for recurrence or death, 0.57; 98.4% CI, 0.43 to 0.74; P<0.001). At 18 months, the rate of recurrence free survival was 71.4% (95% CI, 66.8 to 75.4) in the pembrolizumab group and 53.2% (95% CI, 47.9 to 58.2) in the placebo group.2

In patients with positive PD-L1 tumour expression the 1-year recurrence-free survival rate was 77.1% (95% CI, 72.7 to 80.9) in the pembrolizumab group and 62.6% (95% CI, 57.7 to 67.0) in the placebo group (hazard ratio, 0.54; 95% CI 0.42 to 0.69; P<0.001).2

Adverse events of any grade that were considered to be related to the trial regimen occurred in 396 patients (77.8%) in the pembrolizumab group and in 332 patients (66.1%) in the placebo group.2 Serious treatment related adverse events occurred in 75 patients (14.7%) in the pembrolizumab group and in 17 patients (3.4%) in the placebo group.2

The most frequent toxicities reported were fatigue or asthenia (weakness), rash, pruritus, diarrhoea and arthralgia and were similar in both trial groups. Immune-related adverse events of any grade occurred in 190 (37.3%) patients in the pembrolizumab group and in 45 (9.0%) patients in the placebo group.2 There was one pembrolizumab-related death due to myositis.2 All safety issues are documented in pembrolizumab’s SmPC.[ix]

About Pembrolizumab9

Pembrolizumab is a humanized monoclonal antibody that works by increasing the ability of the body’s immune system to help detect and fight tumour cells. Pembrolizumab blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking the interaction with the receptor ligands, pembrolizumab releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumour immune response.9

For detailed information regarding pembrolizumab, please refer to the Summary of Product Characteristics, available online at: https://www.medicines.org.uk/emc/product/6947/smpc.

About the Cancer Drugs Fund4

The Cancer Drugs Fund (CDF) was set up in April 2011 to allow NHS patients in England access to cancer drugs which are not routinely available on the NHS. In October 2015, the CDF was closed to new drugs and a full public consultation carried out to make the fund more sustainable. In July 2016, it re-opened following extensive reforms. The process for assessing cancer drugs that is used by the NICE now includes a decision about funding under the CDF.

 

About MSD

For more than a century, MSD, a leading global biopharmaceutical company, has been inventing for life, bringing forward medicines and vaccines for the world’s most challenging diseases. MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching policies, programmes and partnerships. Today, MSD continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world. For more information, visit www.msd-UK.com and connect with us on Twitter @MSDintheUK

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

 

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s 2017 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

 

[i] National Institute for Health and Care Excellence. Final Appraisal Document. Pembrolizumab for Adjuvant Treatment of Resected Melanoma with High Risk of Recurrence. (2018). [online]. Available at: https://www.nice.org.uk/guidance/gid-ta10247/documents/html-content-2.

[ii] Eggermont et al. Adjuvant Pembrolizumab versus Placebo in Resected Stage III Melanoma. (2018) The New England Journal of Medicine.

[iii] Cancer Research UK. (2018). Melanoma skin cancer incidence statistics. [online] Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/melanoma-skin-cancer#heading-Zero [Accessed 26 Nov. 2018].

[iv] NICE – Cancer Drugs Fund. (2018) [online] Available at: https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/cancer-drugs-fund. [Accessed 23 October 2018].

[v] Acadia Dermatology. (2018). Melanoma - The Most Serious Form Of Skin Cancer - Acadia Dermatology. [online] Available at: https://www.acadiaderm.com/info-articles/melanoma-the-most-serious-form-of-skin-cancer [Accessed 8 Nov. 2018].

[vi] Cancer Research UK. (2018). Melanoma Skin Cancer – Stages and Types. [online] Available: https://www.cancerresearchuk.org/about-cancer/melanoma/stages-types/stage-3. [Last Accessed December 2018]

[vii] National Institute of Health and Care Excellence. Health Technology Appraisal

Pembrolizumab for adjuvant treatment of resected melanoma with high risk of recurrence.

Final scope. (2018) [online]. Available: https://www.nice.org.uk/guidance/gid-ta10247/documents/final-scope (Accessed December 2018)

[viii] European Organisation for Research and Treatment of Cancer. (2018). [online] Available at: http://www.eortc.org/our-mission/. [Accessed 28 November, 2018].

[ix] Summary of product characteristics. Pembrolizumab. [online] Available at: https://www.medicines.org.uk/emc/product/6947/smpc . [Accessed 28 November, 2018]

Editor's Details

Jordan Hodges
jordan.hodges@redconsultancy.com

Last updated on: 18/12/2018

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