Keytruda
Generic name: pembrolizumab
Treatment for: Melanoma, Metastatic, Non Small Cell Lung Cancer, Head and Neck Cancer, Hodgkin's Lymphoma, Urothelial Carcinoma, Gastric Cancer, Cervical Cancer, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Esophageal Carcinoma, Endometrial Cancer, Squamous Cell Carcinoma, Hepatocellular Carcinoma, Breast Cancer, Biliary Tract Tumor, Malignant Pleural Mesothelioma
Merck to Present New Data in Five Tumor Types from Studies Evaluating Pembrolizumab
WHITEHOUSE STATION, N.J. Sept. 2, 2014 --(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from ongoing clinical trials evaluating the anti-tumor activity of pembrolizumab, the company’s investigational anti-PD-1 antibody, at the European Society of Medical Oncology (ESMO) 2014 in Madrid, Spain, September 26 – 30. Data on pembrolizumab are planned to be presented in five advanced solid tumor types, including the first presentation of data evaluating pembrolizumab for the treatment of gastric and bladder (urothelial tract) cancers. Three late-breaking abstracts have been accepted for oral presentation.
“We are pleased to present the first data for our investigational anti-PD-1 antibody pembrolizumab in gastric and bladder cancers at ESMO 2014,” said Dr. Roy Baynes, senior vice president, Global Clinical Development, Merck Research Laboratories. “The presentation of data for five advanced tumor types underscores the breadth of Merck’s immuno-oncology development program evaluating pembrolizumab in diverse tumor types, different stages of disease and multiple lines of therapy.”
Abstracts involving Merck Oncology-sponsored studies at ESMO 2014 include:
Bladder and Gastric Cancers
- (Abstract #LBA23) Late-Breaker (Oral presentation): A Phase 1b Study of Pembrolizumab (Pembro; MK-3475) in Patients (Pts) With Advanced Urothelial Tract Cancer. E. Plimack. Monday, September 29, 11:00 AM-11:15 AM CEST. Location: Sevilla.
- (Abstract #LBA15) Late-Breaker (Oral presentation): A Phase 1b Study of Pembrolizumab (Pembro; MK-3475) in Patients (Pts) With Advanced Gastric Cancer. K. Muro. Sunday, September 28. 09:15 AM-09:30 AM CEST. Location: Madrid.
Advanced Melanoma
- (Abstract #LBA34) Late-Breaker (Poster discussion): Pembrolizumab (Pembro; MK-3475) for Advanced Melanoma (MEL): Randomized Comparison of Two Dosing Schedules. C. Robert, Monday, September 29. 1:00 PM-2:00 PM CEST. Location: Valencia.
- (Abstract #1075TiP) Poster: KEYNOTE-029: Phase 1/2 Study of MK-3475 in Combination With Pegylated Interferon Alfa-2b (PEG-IFN) or Ipilimumab (IPI) in Patients (Pts) With Advanced Melanoma (MEL) or Renal Cell Carcinoma (RCC). T.K. Choueiri. Monday, September 29; 12:45 PM-1:45 PM CEST. Location: Poster Area.
- (Abstract #1097P) Poster: PD-L1 Expression and Overall Survival Among Patients With Melanoma. T. Steiniche. Sunday, September 28; 12:45 PM-1:45 PM CEST. Location: Poster Area.
NSCLC
- (Abstract #LBA43) Late-Breaker (Oral presentation): Antitumor Activity of Pembrolizumab (Pembro; MK-3475) and Correlation With Programmed Death Ligand 1 (PD-L1) Expression in a Pooled Analysis of Patients (pts) With Advanced Non–Small Cell Lung Carcinoma (NSCLC). E. Garon. Sunday, September 28; 09:15 AM-10:30 AM CEST. Location: Barcelona.
- (Abstract #1328P) Poster: PD-L1 Expression and Survival Among Advanced Non–Small Cell Lung Cancer (NSCLC) Patients Treated With Chemotherapy. S. Sorensen. Saturday, September 27; 12:45 PM-1:45 PM CEST. Location: Poster Area.
Head and Neck Cancer
- (Abstract #LBA31) Late-Breaker (Poster discussion): A Phase Ib Study of Pembrolizumab (Pembro; MK-3475) in Patients (Pts) With Human Papillomavirus Virus (HPV)-Positive and Negative Head and Neck Cancer (HNC). L. Chow. Sunday, September 28; 1:00 PM-2:00 PM CEST. Location: Poster Area.
For more information about the ESMO Congress and for a complete list of abstract titles, please refer to www.esmo.org/Conferences/ESMO-2014-Congress.
About Pembrolizumab
Pembrolizumab (MK-3475) 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.
Pembrolizumab is currently being evaluated across more than 30 types of cancers, as monotherapy and in combination. It is anticipated that by the end of 2014, the pembrolizumab development program will grow to more than 24 clinical trials, enrolling an estimated 6,000 patients at nearly 300 clinical trial sites worldwide. For information about Merck’s oncology clinical trials, please visit http://www.merck.com/clinical-trials/index.html.
Our Focus on Cancer
Our goal is to translate breakthrough science into biomedical innovations to help people with cancer worldwide. For Merck 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 information about Merck’s commitment to Oncology visit the Oncology Information Center at http://www.mercknewsroom.com/oncology-infocenter.
About Merck
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 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. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
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 Merck’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; Merck’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 Merck’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Merck 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).
Source: Merck Sharp & Dohme Corp.
Posted: September 2014
Related articles
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Pemetrexed and Platinum Chemotherapy as First-Line Treatment for Adult Patients With Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma (MPM) - September 18, 2024
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Carboplatin and Paclitaxel as Treatment for Adult Patients With Primary Advanced or Recurrent Endometrial Carcinoma - June 17, 2024
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer - January 12, 2024
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Chemotherapy as First-Line Treatment for Locally Advanced Unresectable or Metastatic HER2-Negative Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma - November 16, 2023
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Gemcitabine and Cisplatin as Treatment for Patients With Locally Advanced Unresectable or Metastatic Biliary Tract Cancer - November 1, 2023
- FDA Approves Keytruda (pembrolizumab) for Treatment of Patients With Resectable NSCLC in Combination With Chemotherapy as Neoadjuvant Treatment, Then Single Agent as Adjuvant Treatment After Surgery - October 16, 2023
- FDA Approves Merck’s Keytruda (pembrolizumab) in Combination With Padcev (enfortumab vedotin-ejfv) for First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer - April 3, 2023
- FDA Converts to Full Approval Indication for Keytruda (pembrolizumab) for Certain Adult and Pediatric Patients With Advanced Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors - March 29, 2023
- FDA Approves Keytruda (pembrolizumab) as Adjuvant Treatment Following Surgical Resection and Platinum-Based Chemotherapy for Patients With Stage IB (T2a ≥4 Centimeters), II, or IIIA Non-Small Cell Lung Cancer (NSCLC) - January 27, 2023
- FDA Approves Merck’s Keytruda (pembrolizumab) for Patients With MSI‑H/dMMR Advanced Endometrial Carcinoma, Who Have Disease Progression Following Prior Systemic Therapy in Any Setting and Are Not Candidates for Curative Surgery or Radiation - March 21, 2022
- FDA Approves Merck’s Keytruda (pembrolizumab) as Adjuvant Therapy for Certain Patients With Renal Cell Carcinoma (RCC) Following Surgery - November 18, 2021
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Chemotherapy, With or Without Bevacizumab, as Treatment for Patients With Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 (CPS ≥1) - October 13, 2021
- FDA Approves Keytruda (pembrolizumab) Plus Lenvima (lenvatinib) Combination for First-Line Treatment of Adult Patients With Advanced Renal Cell Carcinoma (RCC) - August 11, 2021
- FDA Approves Keytruda (pembrolizumab) for Treatment of Patients With High-Risk Early-Stage Triple-Negative Breast Cancer in Combination With Chemotherapy as Neoadjuvant Treatment, Then Continued as Single Agent as Adjuvant Treatment After Surgery - July 27, 2021
- FDA Approves Keytruda (pembrolizumab) Plus Lenvima (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma - July 22, 2021
- FDA Approves Expanded Indication for Merck’s Keytruda (pembrolizumab) in Locally Advanced Cutaneous Squamous Cell Carcinoma (cSCC) - July 6, 2021
- FDA Approves Merck’s Keytruda (pembrolizumab) Combined With Trastuzumab and Chemotherapy as First-line Treatment in Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma - May 5, 2021
- FDA Approves Merck’s Keytruda (pembrolizumab) Plus Platinum- and Fluoropyrimidine-Based Chemotherapy for Treatment of Certain Patients With Locally Advanced or Metastatic Esophageal or Gastroesophageal Junction (GEJ) Carcinoma - March 23, 2021
- FDA Approves Merck’s Keytruda (pembrolizumab) in Combination With Chemotherapy for Patients With Locally Recurrent Unresectable or Metastatic Triple‑Negative Breast Cancer Whose Tumors Express PD-L1 (CPS ≥10) - November 13, 2020
- FDA Approves Expanded Indication for Merck’s Keytruda (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL) - October 15, 2020
- FDA Approves Merck’s Keytruda (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer - June 29, 2020
- FDA Approves Merck’s Keytruda (pembrolizumab) for the Treatment of Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma (cSCC) that is Not Curable by Surgery or Radiation - June 24, 2020
- FDA Approves Second Biomarker-Based Indication for Merck’s Keytruda (pembrolizumab), Regardless of Tumor Type - June 17, 2020
- FDA Approves Merck’s Keytruda (pembrolizumab) for Use at an Additional Recommended Dose of 400 mg Every Six Weeks for All Approved Adult Indications - April 28, 2020
- FDA Approves Keytruda (pembrolizumab) for Patients With BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer - January 8, 2020
- FDA Approves Keytruda (pembrolizumab) plus Lenvima (lenvatinib) Combination Treatment for Patients with Certain Types of Endometrial Carcinoma - September 17, 2019
- FDA Approves Keytruda (pembrolizumab) for Recurrent Locally Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus - July 31, 2019
- FDA Approves Keytruda (pembrolizumab) for the Treatment of Metastatic Small Cell Lung Cancer (SCLC) - June 18, 2019
- FDA Approves Keytruda (pembrolizumab) for First-Line Treatment of Head and Neck Squamous Cell Carcinoma - June 11, 2019
- FDA Approves Keytruda (pembrolizumab) in Combination With Inlyta (axitinib) as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma (RCC) - April 22, 2019
- FDA Approves Expanded Monotherapy Label for Merck’s Keytruda (pembrolizumab) for First-Line Treatment of NSCLC - April 11, 2019
- FDA Approves Keytruda (pembrolizumab) for the Adjuvant Treatment of Patients with Melanoma with Involvement of Lymph Node(s) Following Complete Resection - February 19, 2019
- FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma - December 19, 2018
- FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Hepatocellular Carcinoma (HCC) Who Have Been Previously Treated with Sorafenib - November 9, 2018
- FDA Approves Keytruda (pembrolizumab) in Combination with Carboplatin and Either Paclitaxel or Nab-Paclitaxel for the First-Line Treatment of Patients with Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) - October 30, 2018
- FDA Approves Expanded Label for Merck’s Keytruda (pembrolizumab) in Patients with Metastatic Nonsquamous NSCLC with No EGFR or ALK Genomic Tumor Aberrations - August 21, 2018
- FDA Approves Keytruda (pembrolizumab) for Treatment of Refractory or Relapsed Primary Mediastinal Large B-Cell Lymphoma (PMBCL) - June 13, 2018
- FDA Approves Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 - June 12, 2018
- FDA Approves Merck’s Keytruda (pembrolizumab) for Previously Treated Patients with Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Whose Tumors Express PD-L1 - September 22, 2017
- FDA Approves Keytruda (pembrolizumab) as First Cancer Treatment for any Solid Tumor with a Specific Genetic Feature - May 23, 2017
- FDA Approves Merck’s Keytruda (pembrolizumab) for Certain Patients with Locally Advanced or Metastatic Urothelial Carcinoma - May 18, 2017
- FDA Approves Merck’s Keytruda (pembrolizumab) as First-Line Combination Therapy for Patients with Metastatic Nonsquamous Non-Small Cell Lung Cancer (NSCLC), Irrespective of PD-L1 Expression - May 10, 2017
- FDA Approves Merck’s Keytruda (pembrolizumab) for Classical Hodgkin Lymphoma (cHL) - March 15, 2017
- FDA Approves Merck’s Keytruda (pembrolizumab) for First-Line Treatment of Certain Patients with Metastatic Non-Small Cell Lung Cancer - October 24, 2016
- FDA Approves Merck’s Keytruda (pembrolizumab) for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma - August 5, 2016
- FDA Approves Expanded Indication for Keytruda (pembrolizumab) for the Treatment of Patients with Advanced Melanoma - December 18, 2015
- FDA Approves Keytruda (pembrolizumab) for Advanced Non-Small Cell Lung Cancer - October 2, 2015
- FDA Approves Keytruda (pembrolizumab) for Advanced Melanoma - September 4, 2014
- Merck’s Investigational Anti-PD-1 Antibody, Pembrolizumab, Under Regulatory Review in Europe for Advanced Melanoma - June 30, 2014
Keytruda (pembrolizumab) FDA Approval History
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.