MSD Announces First Presentation of Early Data on the Investigational Use of Pembrolizumab in Patients with Advanced Bladder Cancer at ESMO 2014

Europe, North America, Spain, United States

Pembrolizumab monotherapy achieved 24 percent overall response rate in patients with PD-L1 positive, advanced bladder (urothelial) cancer

Planned Phase 3 study in advanced bladder cancer to be initiated by the end of 2014

29/09/2014 — WHITEHOUSE STATION, N.J. — (BUSINESS WIRE)

MSD, known as Merck in the United States and Canada, today announced the first presentation of data on the investigational use of pembrolizumab – the company’s anti-PD-1 therapy – in PD-L1 positive, advanced urothelial cancer, (also known as bladder cancer). The early findings presented showed a confirmed overall response rate of 24 percent with pembrolizumab as monotherapy, as measured by RECIST v1.1, central review (n= 7/29: 95% CI, 10.3-43.5) including a complete response rate of 10 percent (3/29). At the time of analysis, response durations ranged from 16+ to 40+ weeks with six of the seven responders continuing on therapy. In the ongoing study, 64 percent (61/95) of patients screened had tumours that were determined to be positive for PD-L1 expression.

These data, from a cohort of the ongoing Phase 1b KEYNOTE-012 study, were presented today, as part of a late-breaking oral session, by Dr. Elizabeth R. Plimack, Fox Chase Cancer Center, Philadelphia, at the European Society for Medical Oncology (ESMO) 2014 Congress in Madrid, Spain (ABSTRACT #LBA23).

“Although at this stage the dataset is small, we are encouraged by the response rate, complete response rate, and the durability of the response in patients suffering from advanced bladder cancer,” said Dr. Alise Reicin, vice president, oncology, Merck Research Laboratories. “As communicated previously, based on these data, MSD will initiate a Phase 3 study this year to better understand the potential of pembrolizumab in advanced bladder cancer.”

Early findings for investigational use of pembrolizumab in advanced bladder cancer

Data from a cohort of the ongoing Phase 1b KEYNOTE-012 study evaluated pembrolizumab monotherapy at 10 mg/kg every two weeks in patients with advanced bladder cancer whose tumours were determined to be positive for PD-L1 expression (n=29). As measured by MSD’s proprietary immunohistochemistry (IHC) clinical trial assay, tumours were classified as PD-L1 positive based on greater than or equal to one percent of tumour cells demonstrating expression of the PD-L1 marker, or any positive staining with the same reagent in tumour stroma. The majority of patients had received one or more prior lines of therapy.

Antitumour activity by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1*

Patients Evaluable for Response (n=29)
n Percentage 95% CI
Overall Response Rate (ORR) 7 24.1 10.3 – 43.5
Best overall response
  • Complete response
3 10.3 2.2 – 27.4
  • Partial response
4 13.8 3.9 – 31.7
  • Stable disease
4 13.8 3.9 – 31.7
  • Progressive disease
14 48.3 29.4 – 67.5
  • No assessment
4 13.8 3.9 – 31.7

*Analysis cut-off date: 6 August 2014

At six months, 58 percent of patients were alive and median overall survival was 9.3 months (95% CI, 3.6-NR). Additionally, tumour shrinkage was achieved in 64 percent of evaluable patients with one post-baseline treatment scan. Analysis of the relationship between PD-L1 expression and clinical outcomes is ongoing.

Adverse events were consistent with previously reported safety data for pembrolizumab. The most common investigator-assessed, treatment-related adverse events (occurring in greater than or equal to two patients) included fatigue (18%), peripheral edema (12%), and nausea (9%). Grade 3-5 investigator-assessed, treatment-related adverse events occurred in a total of four patients. One infusion-related reaction was observed and one patient discontinued pembrolizumab due to a treatment-related adverse reaction. There were no treatment-related deaths.

About the KEYNOTE-012 study

KEYNOTE-012 is an ongoing multi-center, non-randomised Phase 1b trial evaluating the safety, tolerability, and anti-tumour activity of pembrolizumab monotherapy in patients with advanced triple negative breast cancer (TNBC), advanced head and neck cancer, advanced urothelial (bladder) cancer, or advanced gastric cancer. The primary endpoints of the study include overall safety, tolerability, and anti-tumour activity (as measured by RECIST v1.1) in PD-L1 positive tumours; secondary endpoints include progression-free survival (PFS), overall survival (OS) and duration of response.

Notes to the Editors

About pembrolizumab

Pembrolizumab is a humanised 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-tumour immune response.

About bladder (urothelial tract) cancer

Bladder cancer is the most common form of urothelial cancer, a cancer that forms in the layer of tissue (also called the urothelium) that lines the urethra, bladder, ureters, prostate and renal pelvis.1 Among others, risk factors for bladder cancer include smoking, exposure to certain industrial chemicals in the workplace, race, ethnicity, age, and gender.2 The incidence of bladder cancer is elevated in North America, Europe, North Africa, the Middle East, Australia and New Zealand.3 In 2012, there were an estimated 430,000 new cases of bladder cancer and 165,000 bladder cancer deaths worldwide.3

Our focus on cancer

Our goal is to translate breakthrough science into biomedical innovations to help people with cancer worldwide. For MSD Oncology, helping people fight cancer is our passion, supporting accessibility to our cancer medicines is our commitment, and pursuing research in immuno-oncology is our focus to potentially bring new hope to people with cancer. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

About MSD

Today’s MSD is a global healthcare leader working to help the world be well. MSD is known as Merck in the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care 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.

Forward-Looking Statement

This news release 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 MSD’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 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; MSD’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 MSD’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

MSD 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 Merck’s 2013 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 National Cancer Institute. General Information About Bladder and Other Urothelial Cancers. http://www.cancer.gov/cancertopics/pdq/screening/bladder/Patient/page2. Accessed September 23, 2014.

2 American Cancer Society. What are the risk factors for bladder cancer? http://www.cancer.org/cancer/bladdercancer/detailedguide/bladder-cancer-risk-factors. Accessed September 23, 2014.

3 WHO. 5.10 Bladder Cancer. In: Stewart BW, Wild CP, eds. World Cancer Report 2014. Lyon, France: WHO Press; 2014: 681-695.

 


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