Merck & Co.'s Pembrolizumab Meets Primary Goal in Mid-Stage Study
KIRKLAND, QC , Oct. 28, 2015 /CNW Telbec/ - Merck (MRK), known as MSD outside Canada and the United States , today announced topline results from the KEYNOTE-010 study of pembrolizumab in advanced non-small-cell lung cancer (NSCLC) demonstrating that the trial met its primary objective.
KEYNOTE-010 is a randomized, pivotal Phase 2/3 trial comparing two doses of pembrolizumab (2mg/kg dose and a higher 10mg/kg dose, each given every 3 weeks), to docetaxel, a commonly used chemotherapy. Patients were enrolled who had failed prior systemic therapy for advanced NSCLC and whose tumors had PD-L1 (programmed death ligand-1) expression tumor proportion scores (TPS) of 1 percent or more. Outcomes were assessed in patients whose tumors were strongly PD-L1 positive (defined as TPS of 50 percent or more), and in all PD-L1 positive patients.
A topline analysis revealed that treatment with pembrolizumab was associated with longer overall survival (OS) compared with docetaxel treatment. This was true for both doses of pembrolizumab, which showed similar efficacy. It was also true in both the first set of patients analyzed – those with a TPS of 50 percent or greater – and for all enrolled patients, all of whom had a TPS of 1 percent or greater.
Treatment with pembrolizumab, at both doses, also provided superior progression-free survival (PFS) versus that achieved following treatment with docetaxel in patients whose tumors had TPS values equal to or greater than 50 percent. For PFS, pembrolizumab treatment was numerically but not statistically superior to docetaxel in the all PD-L1 positive group, again at both doses. The safety profile of pembrolizumab in this trial was consistent with that observed in previously reported studies in patients with advanced NSCLC.
"The results from this trial provide part of a growing body of evidence supporting the potential of pembrolizumab in the treatment of non-small-cell lung cancer," said Dr. Roger M. Perlmutter , president, Merck Research Laboratories. "Advancing the standard of care in cancer requires a collaborative effort, and we are grateful to the patients, institutions and caregivers who participated in this study. We look forward to sharing our complete data with the scientific community and with regulatory agencies in the near future."
About the KEYNOTE-010 Study
KEYNOTE-010 is a global, open-label, randomized, pivotal Phase 2/3 study (ClinicalTrials.gov, NCT01905657) evaluating two doses of pembrolizumab (2 mg/kg or 10 mg/kg every three weeks) compared to docetaxel (75 mg/m2 every three weeks) in 1034 patients with NSCLC who experienced disease progression after platinum-containing systemic therapy and whose tumors expressed PD-L1. The primary endpoints were OS and PFS. Tumor response was assessed at week 12, then every 6 weeks thereafter per RECIST 1.1 criteria by independent, central, blinded, radiographic review and investigator-assessed, immune-related response criteria.
About KEYTRUDA® (pembrolizumab) in Canada
Pembrolizumab, known under the brand name KEYTRUDA®, is a humanized monoclonal antibody that 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-tumor immune response. In Canada , KEYTRUDA has been approved for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor. An improvement in survival or disease-related symptoms has not yet been established. KEYTRUDA has been issued marketing authorization with conditions, pending the results of studies to verify its clinical benefit.
Merck is advancing a broad and fast-growing clinical development program that has rapidly expanded to encompass more than 30 tumor types in more than 130 clinical trials, of which more than 70 trials combine pembrolizumab with other cancer treatments.
About 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. Each year, more people die of lung cancer than die of colon, breast, and prostate cancers combined. The two main types of lung cancer are non-small-cell and small-cell. NSCLC is the most common type of lung cancer, accounting for about 85 percent of all cases. The five-year relative survival rate for patients suffering from highly advanced, metastatic (Stage IV) lung cancers is estimated to be four percent.
Lung cancer is the most commonly diagnosed cancer in Canada (excluding non-melanoma skin cancers). It is the leading cause of death from cancer for both men and women in Canada . In 2015, it is estimated that 26,600 Canadians will be diagnosed with lung cancer; representing 14% of all new cancer cases, and that 20,900 Canadians will die from lung cancer, representing 27% of all cancer deaths.
In 2015, it is estimated that, on average, 73 Canadians will be diagnosed with lung cancer every day, and 57 Canadians will die from lung cancer every day.1
Our Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck 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. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.
About Merck Canada
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada . 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 healthcare through far-reaching policies, programs and partnerships. For more information about our operations in Canada , visit www.merck.ca.
Forward-Looking Statement of Merck & Co. Inc., Kenilworth, NJ , USA
This news release of Merck & Co., Inc., Kenilworth, NJ , USA (the "Company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States 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 healthcare legislation in the United States and internationally; global trends toward healthcare 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 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 2014 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).
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1 Canadian Cancer Society. Lung Cancer. [https://www.cancer.ca/en/cancer-information/cancer-type/lung/statistics/?region=on], accessed on October 26 , 2015.
Please see the product monograph for KEYTRUDA (pembrolizumab) at: http://www.merck.ca/assets/en/pdf/products/KEYTRUDA-PM_E.pdf
SOURCE Merck Canada Inc.
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