New Data from KEYNOTE-028, MSD’s Trial Evaluating KEYTRUDA® (pembrolizumab) Across a Range of Cancer Types, Presented at 2015 European Cancer Congress

MSD, known as Merck (NYSE:MRK) in the United States and Canada, today announced new findings from the KEYNOTE-028 Phase 1b study, the clinical trial investigating the use of the company’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in multiple, difficult-to-treat cancers. Data from this trial, to be presented at the European Cancer Congress (ECC) in Vienna, Austria, Sept. 25-29, include the first-time findings for KEYTRUDA in two gastrointestinal cancers, advanced anal cancer and advanced biliary tract cancer, and add to MSD’s growing body of clinical data for KEYTRUDA.

New Findings Show Anti-Tumor Activity of KEYTRUDA® (pembrolizumab) in Patients with Advanced Nasopharyngeal Carcinoma

MSD, known as Merck (NYSE:MRK) in the United States and Canada, today announced the first-time presentation of findings investigating the use of KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, as a monotherapy in patients with advanced unresectable nasopharyngeal carcinoma (NPC) – a type of head and neck cancer – whose tumors express PD-L1 (≥1% of cells in tumor nests or PD-L1+ bands in stroma). Data were from a Phase 1b study (KEYNOTE-028) and showed an overall response rate (ORR) (confirmed and unconfirmed) of 22.2 percent (95% CI, 8.6-42.3) in evaluable patients (n=27) who were treated with KEYTRUDA. Results were presented in an oral session by Dr. Chiun Hsu, National Taiwan University Hospital, at the European Cancer Congress (ECC) in Vienna (Abstract #2801).

MSDs Pivotal Phase 3 C-EDGE Programme Evaluating Grazoprevir/Elbasvir Shows High Sustained Virologic Responses Across Broad Range of Patients with Chronic Hepatitis C Virus Infection

MSD, known as Merck (NYSE:MRK) in the United States and Canada, announced today the first presentations of data from the companys ongoing C-EDGE pivotal Phase 3 clinical trial programme evaluating the investigational once-daily tablet grazoprevir/elbasvir (100mg/50mg) in patients with or without cirrhosis who are infected with chronic hepatitis C virus (HCV) genotypes 1, 4 or 6 (GT1, 4 or 6).1 Patients in both the HCV infected, treatment-naïve (C-EDGE TN), and HIV/HCV co-infected, treatment-naïve (C-EDGE CO-INFXN) trials treated for 12 weeks achieved rates of sustained virologic response 12 weeks after the completion of treatment (SVR12) of 95 percent (299/316 and 207/218, respectively). In addition, HCV infected, treatment-experienced patients (C-EDGE TE) treated with or without ribavirin (RBV) for 12 weeks achieved SVR12 rates of 94 percent (98/104) and 92 percent (97/105), respectively, and those treated for 16 weeks achieved SVR12 rates of 97 percent (103/106) and 92 percent (97/105), respectively. These data were presented at The International Liver CongressTM 2015 the 50th annual congress of the European Association for the Study of the Liver (Abstract #G07, E-Poster P0886 and E-Poster P0887). A paper detailing the findings of C-EDGE TN was published online in the Annals of Internal Medicine today.

MSD Announces Results from Phase 2/3 Study of Investigational Chronic Hepatitis C Therapy Grazoprevir/Elbasvir in Patients with Advanced Chronic Kidney Disease

MSD, known as Merck (NYSE:MRK) in the United States and Canada, today announced the first presentation of data from C-SURFER, the companys Phase 2/3 clinical trial evaluating the investigational once-daily treatment regimen of grazoprevir (100mg) and elbasvir (50mg) in patients with advanced chronic kidney disease (CKD) infected with chronic hepatitis C virus (HCV) genotype 1 (GT1).1 Treatment-naïve patients and patients who failed prior pegylated interferon HCV therapy, with or without cirrhosis, all of whom had CKD stages 4 or 5, were enrolled.2 Following 12 weeks of treatment with grazoprevir and elbasvir, 99 percent (115/116) of patients in the pre-specified primary population for analysis of efficacy data achieved a sustained virologic response 12 weeks after the completion of treatment (SVR12).3 These data will be presented today at The International Liver CongressTM 2015 the 50th annual congress of the European Association for the Study of the Liver (late breaking E-Poster #LP02).