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European Commission Approves KEYTRUDA® (pembrolizumab) Making it the First and Only Immunotherapy Licensed in Combination with Chemotherapy to Treat Patients with Non-Squamous Non-Small Cell Lung Cancer

RED
Posted on: 10 Sep 18

EMBARGOED FOR RELEASE TO UK MEDICAL AND PHARMACEUTICAL TRADE MEDIA ONLY UNTIL SEPTEMBER 10, 2018 11.46 

European Commission Approves KEYTRUDA® (pembrolizumab) Making it the First and Only Immunotherapy Licensed in Combination with Chemotherapy to Treat Patients with Non-Squamous Non-Small Cell Lung Cancer[1]

 

Pembrolizumab Plus Pemetrexed and Platinum-Based Chemotherapy Reduces Risk of Death by more than 50% Compared to Chemotherapy Alone

 

Hoddesdon, September 10, 2018 - Today, MSD (tradename of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK)) are proud to announce that the European Commission (EC) has granted KEYTRUDA® (pembrolizumab) a licence for use in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults who have no EGFR or ALK positive mutations.1 Pembrolizumab plus pemetrexed and platinum-based chemotherapy reduces the risk of death by more than 50% compared to pemetrexed and platinum-based chemotherapy alone.[2]

 

This decision makes pembrolizumab the first immunotherapy to be approved by the EC for treatment of NSCLC in combination with chemotherapy and is based on the KEYNOTE-189 clinical trial, which looked at the treatment in patients who were non, low and high expressors of the PD-L1 biomarker.2

 

This new indication allows patients to be treated with pembrolizumab in combination with pemetrexed and platinum-based chemotherapy regardless of whether their tumours are positive or negative for PD-L1 expression.1

 

In the KEYNOTE-189 study a 51% reduction in the risk of death was observed in patients with non-squamous NSCLC who were treated with pembrolizumab in combination with pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) compared to pemetrexed and platinum-based chemotherapy alone.2 A reduction in the risk of disease progression or death of 48% was also observed with pembrolizumab in combination with pemetrexed and platinum-based chemotherapy. Overall survival (OS) and progression-free survival (PFS) were co-primary endpoints of the KEYNOTE-189 study.2  The decision by the EC to grant this new indication marks the third indication for pembrolizumab in advanced NSCLC based on overall survival data.1,[3]

 

Gary Middleton, Professor of Medical Oncology at the University of Birmingham, said, "This decision is likely to bring a step change in the way we treat lung cancer. It opens up treatment with pembrolizumab to anyone with non-squamous, non-small cell lung cancer, the most common type of lung cancer, that has spread to other parts of the body. Since the arrival of immunotherapies there has been tremendous progress in the treatment of lung cancer. We know that the earlier patients get the best treatment for them, the better their outcomes are likely to be. These innovative therapies have often been restricted to subsets of patients. The decision from the EC extends the use of pembrolizumab to a greater number of patients with non-squamous NSCLC which is incredibly exciting news for patients.”

 

Each year, more people die of lung cancer worldwide than from colon, breast, and prostate cancers combined.[4] Lung cancer is also the third most common cancer in the UK[5] with around 44,500 people diagnosed with the condition every year.[6] The UK has the second worse survival rate for lung cancer in Europe with only 8% of patients surviving more than 5 years – this is ahead of only Bulgaria.[7] There are usually no signs or symptoms in the early stages of lung cancer and 72 to 76% of people are diagnosed at a late stage (stage III or IV) when the cancer has spread outside the lungs, compared to 24 to 28% at stage I or II.[8] Less than 20% of people with Stage IV lung cancer will survive a year or more after diagnosis.[9]

 

Vanessa Beattie, Chair, National Lung Cancer Forum for Nurses and Clinical Nurse Specialist, Aintree University Hospital, Liverpool said, "This decision is a huge step forward for people with lung cancer. It is such a tough condition which can be missed until it is at an advanced stage and very few options are left, beyond palliative care. By combining immunotherapies with chemotherapy we are seeing remarkable benefits for patients, without adding a similar level of side-effects seen with chemotherapy on its own."

 

            Louise Houson, Managing Director, MSD UK & Ireland, said, "Lung cancer remains an area of great unmet need and it takes too many lives each year. We look forward to combining our inventive science with the work of healthcare professionals up and down the country so that, together, we can renew our efforts to reach the best possible outcomes for everyone affected by lung cancer."

 

- ENDS -

 

Notes to editors:

 

About KEYNOTE-1892

Findings from KEYNOTE-1892 showed that the pembrolizumab-pemetrexed-platinum-based chemotherapy combination significantly improved overall survival (OS), reducing the risk of death by over half compared to pemetrexed and platinum-based chemotherapy alone (HR=0.49 [95% CI: 0.38-0.64]; p<0.001). In pre-specified exploratory analyses, an improvement in OS was observed regardless of PD-L1 expression in the three PD-L1 categories that were evaluated, including: patients whose tumours did not express PD-L1 (HR=0.59 [95% CI, 0.38-0.92]); patients whose tumours had PD-L1 tumour proportion scores (TPS) of 1-49 percent (HR=0.55 [95% CI, 0.34-0.90]); and patients who had a TPS of greater than or equal to 50 percent (HR=0.42 [95% CI, 0.26-0.68]). The addition of pembrolizumab to pemetrexed plus platinum-based chemotherapy also achieved significant improvements in progression-free survival (PFS), with a reduction in the risk of disease progression or death of nearly half for patients in the pembrolizumab combination arm, compared with pemetrexed and platinum-based chemotherapy alone (HR=0.52 [95% CI, 0.43-0.64]; p<0.001). A PFS improvement in the pembrolizumab combination group was observed in patients whose tumours did not express PD-L1 (HR=0.75 [95% CI, 0.53-1.05]); patients with a TPS of 1-49 percent (HR=0.55 [95% CI, 0.37-0.81]); and patients with a TPS greater than or equal to 50 percent (HR=0.36 [95% CI, 0.25-0.52]).

 

Additional Data and Safety Information from KEYNOTE-189 (Abstract #CT075)2

            KEYNOTE-189, a randomised, double-blind, placebo-controlled, Phase 3 study, evaluated pembrolizumab in combination with pemetrexed and cisplatin or carboplatin, compared with pemetrexed and cisplatin or carboplatin alone, in 616 patients with metastatic non-squamous NSCLC, regardless of PD-L1 expression. Patients had no EGFR or ALK genomic tumour aberrations and had not previously received systemic therapy for advanced disease.  The dual primary endpoints were OS and PFS; secondary endpoints include overall response rate (ORR) and duration of response (DOR).

            With a median follow-up of 10.5 months (range, 0.2-20.4), pembrolizumab in combination with pemetrexed and a platinum chemotherapy demonstrated superior improvements in OS, with a 51 percent reduction in the risk of death, compared with pemetrexed plus platinum chemotherapy alone (HR=0.49 [95% CI: 0.38-0.64]; p<0.001). This finding includes the 50 percent of patients randomized to the pemetrexed and platinum chemotherapy alone group who discontinued all study therapy (n=170) and went on to receive subsequent anti-PD-1 or PD-L1 therapy, including 67 who received pembrolizumab monotherapy as part of study crossover. Median OS was not reached in the pembrolizumab combination group (95% CI, not estimable), and was 11.3 months in the pemetrexed and platinum chemotherapy alone group (95% CI, 8.7-15.1). In the study, 69.2 percent of patients were alive at 12 months in the pembrolizumab treatment group (95% CI, 64.1-73.8%), compared with 49.4 percent in the chemotherapy alone group (95% CI, 42.1-56.2%).

            In KEYNOTE-189, there was also a significant improvement in PFS for pembrolizumab in combination with pemetrexed and platinum chemotherapy with a 48 percent reduction in the risk of disease progression or death compared with pemetrexed plus platinum chemotherapy alone (HR=0.52 [95% CI, 0.43-0.64]; p<0.001). The median PFS was 8.8 months (95% CI, 7.6-9.2) for the pembrolizumab combination compared with 4.9 months (95% CI, 4.7-5.5) for pemetrexed and platinum chemotherapy alone. The percentage of patients who were alive with no progression of disease at 12 months was 34.1 percent in the pembrolizumab combination group (95% CI, 28.8-39.5%), which was nearly double the percentage (17.3 percent) of the pemetrexed plus platinum chemotherapy group (95% CI, 12.0-23.5%). In addition, improvements in OS and PFS were observed in other patient subgroups evaluated, including age, sex, EGO performance-status score, smoking status, brain metastases at baseline, and type of platinum chemotherapy prescribed (carboplatin or cisplatin).

            In the study, pembrolizumab plus pemetrexed and a platinum chemotherapy also showed an ORR that was more than double the ORR of chemotherapy alone (47.6 percent [95% CI: 42.6-52.5%] compared to 18.9 percent [95% CI: 13.8-25%], respectively, p<0.001). Among patients in the pembrolizumab arm, the median duration of response was 11.2 months (range 1.1+ to 18.0+ months) compared with 7.8 months in the pemetrexed and platinum chemotherapy alone group (range 2.1+ to 16.4+ months). The improvement in response rate occurred in all PD-L1 patient subgroups.

            The safety of pembrolizumab was consistent with what has been seen in previous trials among patients with metastatic NSCLC. Grade 3-5 treatment-related adverse events from any cause occurred in 67.2 percent of patients in the pembrolizumab plus pemetrexed and platinum chemotherapy group, and 65.8 percent in the pemetrexed and platinum chemotherapy alone arm. Treatment-related adverse events of any grade and from any cause with an incidence of 15 percent or more in the pembrolizumab  group were nausea (55.6%), anaemia (46.2%), fatigue (40.7%), constipation (34.8%), diarrhoea (30.9%), decreased appetite (28.1%), neutropenia (27.2%), vomiting (24.2%), cough (21.5%), dyspnoea (21.1%), asthenia (20.5%), rash (20.2%), pyrexia (19.5%), oedema peripheral (19.3%), thrombocytopenia (18.0%), increased lacrimation (17.0%). The most common immune-mediated treatment-related adverse events of any grade in patients receiving pembrolizumab plus pemetrexed and platinum chemotherapy were hypothyroidism (6.7%), pneumonitis (4.4%), hyperthyroidism (4.0%), infusion reactions (2.5%), colitis (2.2%), severe skin toxicity (2.0%), nephritis (1.7%) and hepatitis (1.2%). There were three treatment-related deaths from pneumonitis in the pembrolizumab plus pemetrexed and platinum chemotherapy group. 

 

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.[10]

 

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 Non-Small-Cell Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide.[11] Non-small cell lung cancer is a disease in which cancerous cells form in the tissues of the lung. There are three common types of non-small cell lung cancer. They make up about 87% of all lung cancers in the UK. The three types are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.[12]

 

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

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).

###

 

 

[1] MA authorisation. [LINK TO BE INSERTED WHEN AVAILABLE].

[2] Gandhi, L. (2018). Pembrolizumab plus Chemotherapy in Metastatic Non–Small-Cell Lung Cancer. New England Journal of Medicine, 378(22), pp.2078-2092.

[3] Keytruda SmPC. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003820/WC500190990.pdf [Last accessed August 2018].   

[4] Lungcancercoalition.org. (2018). Lung Cancer Facts | GLCC. [online] Available at: http://www.lungcancercoalition.org/lung-cancer-facts.html [Accessed 3 Sep. 2018].

[5] Cancer Research UK. (2018). Lung cancer statistics. [online] Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/lung-cancer#heading-Zero [Accessed 3 Sep. 2018].

[6] NHS UK. Lung Cancer. Available at: https://www.nhs.uk/conditions/lung-cancer/. [Last accessed August 2018].

[7] British Liver Trust. (2018). 'Burden of cancer’ increasing as UK trails behind Europe in diagnosis, treatment and survival - British Liver Trust. [online] Available at: https://www.britishlivertrust.org.uk/burden-cancer-increasing-uk-trails-behind-europe-diagnosis-treatment-survival/ [Accessed 3 Sep. 2018].

[8] Cancer Research UK. (2018). Lung cancer incidence statistics. [online] Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/lung-cancer/incidence#ref-5 [Accessed August 2018].

[9] Cancer Research UK. Lung Cancer Survival. Available at: https://www.cancerresearchuk.org/about-cancer/lung-cancer/survival. [Last accessed August 2018].

[10] EMC. (2017). KEYTRUDA SPC. [online] Available at: https://www.medicines.org.uk/emc/medicine/30602 [Accessed August 2018].

[11] Cancer factsheet 297. WHO. Available at: http://www.who.int/news-room/fact-sheets/detail/cancer  [Accessed: August 2018].

[12] Cancer Research UK. Types of Lung Cancer. Available at: http://www.cancerresearchuk.org/about-cancer/type/lung-cancer/about/types-of-lung-cancer. [Accessed August 2018].

Editor's Details

Tamara Ghanem
RED
redconsultancy.com
07718 120 684
tamara.ghanem@redconsultancy.com

Last updated on: 10/09/2018

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