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NICE Final Recommendation Supports Inclusion of MSD’s Immunotherapy KEYTRUDA® ▼ (pembrolizumab) in the Cancer Drugs Fund for Treatment of Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer, after Platinum-Containing Chemotherapy

MSD
Posted on: 15 Mar 18
NICE Final Recommendation Supports Inclusion of MSD’s Immunotherapy KEYTRUDA® ▼ (pembrolizumab) in the Cancer Drugs Fund for Treatment of Locally Advanced or Metastatic Urothelial Carcinoma, a Type of Bladder Cancer, after Platinum-Containing Chemotherapy

Hoddesdon, [16 March, 2018] – The National Institute for Care and Health Excellence (NICE) has issued final guidance today that recommends the use of KEYTRUDA®â–¼ (pembrolizumab) within the cancer drugs fund (CDF) as an option for treating locally advanced or metastatic urothelial carcinoma in adults who have had platinum-containing chemotherapy.[i] The recommendation states that pembrolizumab should be stopped at 2 years of uninterrupted treatment or earlier in the event of disease progression, and the conditions in the managed access agreement for pembrolizumab are to be followed.i

 

"Outcomes of patients with chemotherapy refractory metastatic bladder cancer remain stubbornly poor. Pembrolizumab is the first immune check point inhibitor in this setting to show extended survival in this group of patients. This opens a new chapter in the treatment of bladder cancer. NICE's recommendation for pembrolizumab is a bright ray of light for patients with this difficult disease." said Professor Thomas Powles, director of Barts Cancer Centre, London.

 

Andrew Winterbottom, Founder and Director of Fight Bladder Cancer, said the organisation is “absolutely delighted with today’s news that means urothelial cancer, a long-neglected and ignored cancer, finally has a new treatment option which could provide a step change in the patient’s options.”

 

Allen Knight, Chairman from Action Bladder Cancer UK explains, “Bladder cancer is often given a Cinderella status. It is encouraging to see more treatment options being available to people with urothelial carcinomas and as an organisation we are thoroughly excited as to what this means for the future.”

 

Inclusion in the CDF shows that NICE considers that pembrolizumab has potential to satisfy the criteria for routine use on the NHS for this group of bladder cancer patients but needs more investigation, through data collection in the NHS in clinical practice or from further research, 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. The NHS estimates that the CDF will generate savings for the NHS of around £140m over the next five years.[ii] Since its reorganisation in 2016, the CDF has already benefitted 15,700 patients, 5,000 of whom have received treatment earlier than they would have under the previous system.ii

 

Urothelial cancer is the most common form of bladder cancer and accounts for over 90 percent of cases.[iii]  Bladder cancer is the 7th most common cancer in the UK and the 4th most common in men;[iv] yet it is the only top ten cancer where the prognosis is getting worse.4 When advanced, bladder cancer is associated with poor outcomes; approximately 10% of patients survive more than five years.[v] Despite this, research spending on bladder cancer lags way behind other cancers, in 2013 to 2014 only 0.6% of dedicated research funding was given to bladder cancer.4

 

Louise Houson, UK Managing Director, MSD said, “MSD is really pleased that NICE has recommended pembrolizumab for eligible patients with advanced urothelial carcinoma, meaning it can now help bladder cancer patients in addition to those with non-small-cell lung cancer and melanoma.”

 

MSD’s KEYNOTE-045, the clinical study NICE based its decision on, showed pembrolizumab extended overall survival by nearly three months more than chemotherapy (median overall survival was 10.3 months (95% confidence interval [CI], 8.0 to 11.8) in the pembrolizumab group, compared with 7.4 months (95% CI, 6.1 to 8.3) in the chemotherapy group (hazard ratio for death, 0.73; 95% CI, 0.59 to 0.91; P=0.002)).[vi]

 

KEYNOTE-045 was a randomized, pivotal, phase 3 study evaluating pembrolizumab monotherapy compared to investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) in the treatment of patients with metastatic or locally advanced, urothelial cancer (urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra) that had recurred or progressed following platinum-based chemotherapy.vi

 

In KEYNOTE-045, treatment-related adverse events occurred in 60.9% of the patients treated with pembrolizumab, as compared with 90.2% of those who received chemotherapy. The most common treatment-related adverse events of any grade were pruritus (19.5% of the patients), fatigue (13.9%), and nausea (10.9%) in the pembrolizumab group and alopecia (37.6%), fatigue (27.8%), and anemia (24.7%) in the chemotherapy group. There were no treatment-related events of grade 3, 4, or 5 severity that occurred with an incidence of 5% or more in the pembrolizumab group.vi

-ENDS-

 

MSD is a trade name of Merck & Co., Inc., with headquarters in Kenilworth, N.J., U.S.A. KEYTRUDA® is a Registered Trademark of Merck and Co., Inc., Kenilworth, New Jersey, USA.

 

 

For further information, please contact:

Susan Collett (MSD)

01992 455471

Susan.collett@merck.com

Reshma Parmar (Red Health)

020 7025 6585

reshma.parmar@redconsultancy.com

 

 

Notes to editors:

 

About NICE

NICE stands for The National Institute for Health and Care Excellence. It is an independent organisation, set up by the Government in 1999. NICE decides which drugs and treatments are available on the NHS in England and Wales. The All Wales Medicines Strategy Group also makes some decisions for the NHS in Wales. Generally, they follow NICE decisions. Scotland and Northern Ireland have separate organisations to make decisions. Once NICE issues its guidance, NHS trusts must find the money to make those drugs or treatments available.[vii]

 

About the Cancer Drugs Fund

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.[viii]

 

About Pembrolizumab

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.[ix] For detailed information regarding pembrolizumab, please refer to the Summary of Product Characteristics, available online at https://www.medicines.org.uk/emc/medicine/30602

About Bladder Cancer

 

Bladder cancer begins when cells in the urinary bladder start to grow uncontrollably. As more cancer cells develop, they can form a tumour and spread to other areas of the body. Urothelial carcinoma, the most common type of bladder cancer, starts in the urothelial cells that line the inside of the bladder.3 In 2014, approximately 10,000 people were diagnosed with bladder cancer in the UK and 5,369 died from the disease.[x],[xi] Bladder cancer is more common in people over 60.[xii] The most common symptom of bladder cancer is blood in the urine, with the second-most common being bladder irritation. These can include needing to urinate more frequently than normal, having to rush to the toilet, having to get up a lot at night or finding it painful to wee.[xiii] Smoking causes about a third of all bladder cancers in both men and women.[xiv]

 

About KEYNOTE-045vi

The approval in patients previously treated with platinum-containing chemotherapy is based on data from a multicenter, randomized, controlled trial, KEYNOTE-045, investigating pembrolizumab in patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy. Patients must have received a first-line platinum-containing regimen for locally advanced/metastatic disease or as neoadjuvant/adjuvant treatment, with recurrence/progression ≤12 months following completion of therapy. Patients were randomized (1:1) to receive either pembrolizumab 200 mg every three weeks (n=270) or investigator’s choice of any of the following chemotherapy regimens, all given intravenously every three weeks (n=272): paclitaxel 175 mg/m2, docetaxel 75 mg/m2, or vinflunine 320 mg/m2. Patients were treated with pembrolizumab until unacceptable toxicity or disease progression, or for up to 24 months in patients without disease progression. The study excluded patients with autoimmune disease, a medical condition that required immunosuppression and patients with more than two prior lines of systemic chemotherapy for metastatic urothelial cancer. The primary efficacy outcomes were OS and progression-free survival (PFS) as assessed by BICR using recist v1.1; secondary outcome measures were ORR (as assessed by BICR using recist v1.1) and duration of response.

 

In the study, pembrolizumab demonstrated a statistically significant improvement in OS compared to chemotherapy. Findings demonstrated that pembrolizumab resulted in a 27 percent reduction in the risk of death compared to chemotherapy – with 155 events (57%) observed in the pembrolizumab arm, compared to 179 events (66%) in the chemotherapy arm (HR, 0.73 [95% CI: 0.59, 0.91], p=0.002); the median OS was 10.3 months (95% CI: 8.0, 11.8) in the pembrolizumab (pembrolizumab) arm, compared to 7.4 months (95% CI: 6.1, 8.3) in the chemotherapy arm.

 

There was no statistically significant difference between pembrolizumab and chemotherapy with respect to PFS. There were 218 events (81%) observed in the pembrolizumab arm, compared to 219 events (81%) in the chemotherapy arm (HR, 0.98 [95% CI: 0.81, 1.19], p=0.416). The median PFS was 2.1 months (95% CI: 2.0, 2.2) in the pembrolizumab arm, compared to 3.3 months (95% CI: 2.3, 3.5) in the chemotherapy arm. 

 

The ORR was 21 percent (95% CI: 16, 27) for patients receiving pembrolizumab, with a complete response rate of 7 percent and a partial response rate of 14 percent. In the chemotherapy arm, the ORR was 11 percent (95% CI: 8, 16), with a complete response rate of 3 percent and a partial response rate of 8 percent (p=0.001). The median duration of response for patients treated with pembrolizumab had not yet been reached (range: 1.6+ to 15.6+ months), compared to 4.3 months (range: 1.4+ to 15.4+ months) in the chemotherapy arm.

 

In KEYNOTE-045, adverse events that were considered by the investigators to be related to treatment occurred in 60.9% of the patients treated with pembrolizumab, as compared with 90.2% of those who received chemotherapy. The most common treatment-related adverse events of any grade were pruritus (19.5% of the patients), fatigue (13.9%), and nausea (10.9%) in the pembrolizumab group and alopecia (37.6%), fatigue (27.8%), and anemia (24.7%) in the chemotherapy group. There were no treatment-related events of grade 3, 4, or 5 severity that occurred with an incidence of 5% or more in the pembrolizumab group. 

 

Our Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At MSD Oncology, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment.  Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer.

 

About MSD

At MSD, we believe the most important thing we make is a difference. We operate in more than 140 countries and through our prescription medicines, vaccines, biologic therapies, and animal health products we work with customers to bring innovative healthcare solutions to those who need them the most. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programmes and partnerships. For more information visit www.msd-uk.com. The company is known as Merck & Co., Inc., Kenilworth, NJ, USA in the United States and Canada. Everywhere else, we are known as MSD.

 

Forward-Looking Statement

This news release of MSD (the “company”) includes “forward-looking statements” within the meaning of the safe harbour 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 materialise, 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)

 

###

References

 

 

 

 

[i] National Institute for Health and Care Excellence (2018). Final Appraisal Determination:  Pembrolizumab for treating locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy.” [Link to be inserted when it goes live on NICE web site]. (NICE guidance is prepared for the National Health Service in England, and is subject to regular review and may be updated or withdrawn. NICE has not checked the use of its content in this document to confirm that it accurately reflects the NICE publication from which it is taken).

[ii] NHSEngland. New Cancer Drugs Fund benefitting thousands of patients. Available at: https://www.england.nhs.uk/2018/01/new-cancer-drugs-fund-benefiting-thousands-of-patients-and-releasing-140million-for-the-nhs/. [Accessed 6 Feb. 2018].

[iii] Cancerresearchuk.org. (2017). Types | Bladder cancer | Cancer Research UK. [online] Available at: http://www.cancerresearchuk.org/about-cancer/bladder-cancer/types-stages-grades/types [Accessed 16 Nov. 2017].

[iv] Action Bladder Cancer UK. (2017). [online] Actionbladdercanceruk.org. Available at: http://actionbladdercanceruk.org/the-facts-about-bladder-cancer/ [Accessed 16 Nov. 2017].

[v] Cancerresearchuk.org. (2017). Survival for bladder cancer | Cancer Research UK. [online] Available at: http://www.cancerresearchuk.org/about-cancer/bladder-cancer/survival [Accessed 16 Nov. 2017].

[vi] Bellmunt, J., et al. (2017). Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma. New England Journal of Medicine, 376(11), pp.1015-1026.

[vii] Cancer Research UK. What is NICE. Available at: http://www.cancerresearchuk.org/about-cancer/cancers-in-general/cancer-questions/what-is-nice-and-how-does-it-work. [Accessed April 2017].

[viii] NICE. (2017). Cancer Drugs Fund. [online] Available at: https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/cancer-drugs-fund [Accessed 16 Nov. 2017].

[ix] EMC. (2017). KEYTRUDA SPC. [online] Available at: https://www.medicines.org.uk/emc/medicine/30602 [Accessed 16 Nov. 2017].

[x] Cancer Research UK. (2017). Bladder cancer incidence statistics. [online] Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bladder-cancer/incidence [Accessed 12 March 2018].

[xi] Cancer Research UK. (2017). Bladder cancer mortality statistics. [online] Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bladder-cancer/mortality [Accessed 12 March 2018].

[xii]Fightbladdercancer.co.uk. (2017). Key facts | Fight Bladder Cancer. [online] Available at: http://fightbladdercancer.co.uk/learn/key-facts [Accessed 12 March 2018].

[xiii] Cancer.org. (2017). Bladder Cancer Risk Factors. [online] Available at: https://www.cancer.org/cancer/bladder-cancer/causes-risks-prevention/risk-factors.html [Accessed 12 March 2018].

[xiv] Cancerresearchuk.org. (2017). Risks and causes | Bladder cancer | Cancer Research UK. [online] Available at: http://www.cancerresearchuk.org/about-cancer/bladder-cancer/risks-causes [Accessed 12 March. 2018].

Editor's Details

Tamara Ghanem
tamara.ghanem@redconsultancy.com

Last updated on: 15/03/2018

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