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merck & co. inc. (MRK) Key Developments

Merck & Co. Inc. Announces C-EDGE Pivotal Phase 3 Clinical Trial Update

Merck & Co. Inc. announced the first presentations of data from the company’s ongoing C-EDGE pivotal Phase 3 clinical trial program evaluating the investigational once-daily tablet grazoprevir/elbasvir (100mg/50mg) in patients with or without cirrhosis who are infected with chronic hepatitis C virus genotypes 1, 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% (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% (98/104) and 92% (97/105), respectively, and those treated for 16 weeks achieved SVR12 rates of 97% (103/106) and 92% (97/105), respectively. C-EDGE TN is a randomized, blinded, placebo-controlled trial evaluating the efficacy and safety of grazoprevir/elbasvir in treatment-naïve patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 who received therapy for 12 weeks. Patients were randomized to an immediate treatment group that received grazoprevir/elbasvir for 12 weeks or to a deferred treatment group that received placebo for 12 weeks, were followed for an additional four weeks, and then received open label grazoprevir/elbasvir for the next 12 weeks. The primary efficacy analysis included those patients who received immediate treatment with grazoprevir/elbasvir or placebo. Of the 316 patients who received immediate treatment with grazoprevir/elbasvir, 50% were infected with GT1a, 42% with GT1b, 6% with GT4 and 3% with GT6. Overall, 22% of patients had liver cirrhosis. In this study, virologic failure occurred in 13 patients (4%) in the immediate treatment group, including one virologic breakthrough and 12 virologic relapses. Serious adverse events occurred in 3% and 3% patients in the immediate treatment and corresponding placebo arms, respectively; none were considered drug-related. The most common adverse events reported (greater than 5% incidence) in the immediate treatment and corresponding placebo groups, were headache (17%, 18%), fatigue (16%, 17%), nausea (9%, 8%) and arthralgia (6%, 6%), respectively. C-EDGE CO-INFXN is an open label, single-arm study evaluating the efficacy and safety of grazoprevir/elbasvir in treatment-naïve patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 and HIV who received therapy for 12 weeks. Of the 218 patients enrolled in the trial, 66% were infected with HCV GT1a, 21% with GT1b or other GT1, 13% with GT4, and 1% with GT6. Overall, 16% of patients had liver cirrhosis. In this study, virologic failure occurred in seven patients (3%), including six virologic relapses and one reinfection. There were no reported drug-related serious adverse events. The most common (greater than 5% incidence) adverse events reported were fatigue (13%), headache (12%) and nausea (9%). C-EDGE TE is a randomized study evaluating the efficacy and safety of once-daily grazoprevir/elbasvir with or without twice-daily RBV in treatment-experienced (prior null response, partial response or relapse with peg-interferon/RBV) patients with or without cirrhosis infected with chronic HCV GT1, 4 or 6 who received therapy for 12 weeks or 16 weeks. 12 week arms: Of the 209 patients randomized to the 12 week arms, 105 patients received grazoprevir/elbasvir only and 104 patients received grazoprevir/elbasvir plus RBV. Patients in the grazoprevir/elbasvir only arm comprised 58% GT1a, 33% GT1b or other GT1 and 9% GT4. Overall, 35% had liver cirrhosis. Among the 104 patients receiving grazoprevir/elbasvir plus RBV, 58% were infected with chronic HCV GT1a, 28% GT1b or other GT1, and 14% GT4. Overall, 34% had liver cirrhosis. In the grazoprevir/elbasvir only and grazoprevir/elbasvir plus RBV arms, six patients in each arm (6%) were reported to have virologic relapse. No patients were reported to have virologic breakthrough or rebound. Serious adverse events were reported in four patients in the grazoprevir/elbasvir only arm (4%) and three patients in the grazoprevir/elbasvir plus RBV arm (3%). The most common (greater than 10% incidence) adverse events reported in the grazoprevir/elbasvir and grazoprevir/elbasvir plus RBV arms, respectively, were fatigue (19%, 27%), headache (21%, 20%) and nausea (9%, 14%). 16 week arms: Of the 211 patients enrolled in the 16 week arms, 105 patients received grazoprevir/elbasvir only and 106 patients received grazoprevir/elbasvir plus RBV. In the grazoprevir/elbasvir only arm, 46% were infected with chronic HCV GT1a, 46% with GT1b or other GT1, 5% with GT4 and 4% with GT6. Overall, 36% of patients had liver cirrhosis. Among those in the grazoprevir/elbasvir plus RBV arm, 55% were infected with chronic HCV GT1a, 36% with GT1b or other GT1, 8% with GT4, and 2% with GT6. Overall, 35% had liver cirrhosis. Among the patients receiving grazoprevir/elbasvir only, three patients (3%) were reported to have virologic breakthrough or rebound and four patients (4%) were reported to have virologic relapse. No virologic failures occurred in patients receiving grazoprevir/elbasvir plus RBV. Serious adverse events were reported in three patients in the grazoprevir/elbasvir only arm (3%) and four patients in the grazoprevir/elbasvir plus RBV arm (4%). The most common (greater than 10% incidence) adverse events reported in the grazoprevir/elbasvir and grazoprevir/elbasvir plus RBV arms, respectively, were fatigue (16%, 30%), headache (19%, 19%) and nausea (4%,17%).

TetraLogic Pharmaceuticals Corporation and Merck to Collaborate on the Evaluation of Birinapant in Combination with KEYTRUDA(R) (Pembrolizumab) in Solid Tumors

TetraLogic Pharmaceuticals Corporation and Merck announced that they have entered into an oncology clinical study collaboration. The companies will collaborate on a Phase 1 study to evaluate the safety and efficacy of birinapant, TetraLogic's SMAC-mimetic, in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with relapsed or refractory solid tumors. The study is expected to begin in late 2015. KEYTRUDA and birinapant target different elements of cancer's block against the immune system. TetraLogic's birinapant (TL32711) is a potent, bivalent SMAC-mimetic that binds with differential affinity to multiple members of the IAP family in order to re-establish the immune system's ability to kill abnormal cells via an extracellular TNF signal. Merck's KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2. The proposed collaboration is based on preclinical data that suggest SMAC-mimetics have the potential to enhance existing immuno-oncology agents, such as KEYTRUDA. Under the terms of the agreement, TetraLogic and Merck, through subsidiaries, will collaborate on an initial Phase 1 dose-escalation study of birinapant in combination with KEYTRUDA in patients with relapsed or refractory solid tumors. TetraLogic will sponsor and fund the study and Merck will provide KEYTRUDA. The companies have formed a Joint Development Committee to collaboratively oversee the conduct of the study. Results from the study will be used to determine the path for further clinical development of the combination.

Merck & Co Reports Positive Results for PD-1 Inhibitor Keytruda and Files for Expanded Approval for NSCLC Treatment

Merck & Co has announced that it has filed for expanded regulatory approval of programmed cell death protein 1 (PD-1) inhibitor Keytruda (pembrolizumab) with the US FDA for the treatment of advanced non-small-cell lung cancer (NSCLC) in patients whose disease has progressed on or after platinum-containing chemotherapy, as well as an FDA-approved therapy for epidermal growth factor receptor (EGFR) or ALK genomic tumour aberrations, if applicable. The regulatory filing is based on data from KEYNOTE-001 in patients with greater than or equal to 50% tumour expression of programmed death-ligand 1 (PD-L1) protein. A companion diagnostic test, PD-L1 IHC 22C3 PharmDx, used for detection of PD-L1 expression has also been submitted for approval by Dako North America (subsidiary of Agilent Technologies, US) under a premarket approval application. Meanwhile, Merck has presented new positive results from several studies investigating the safety and efficacy of Keytruda across various indications, including metastatic melanoma, NSCLC, and mesothelioma at the annual meeting of the American Association for Cancer Research in Pennsylvania, US, on 19 April. KEYNOTE-001 in NSCLC: Merck has reported positive new data analysis from an ongoing multi-centre, single-arm, open-label Phase Ib trial (KEYNOTE-001) investigating Keytruda in previously treated patients with advanced NSCLC, who have not had previous treatment with a PD-1 inhibitor. Treatment with Keytruda results in an overall response rate (ORR) of 45.4% in patients with greater than or equal to 50% tumour expression of PD-L1 (n=73), meanwhile the ORR dropped to 16.5% in patients demonstrating 1-49% expression of PD-L1 (n=103), and 10.7% in patients with less than 1% expression (n=28). The overall patient population realised an ORR of 19.4% (n=495). With regards to progression-free survival (PFS) the PD-L1 sub-group with greater or equal to 50% PD-L1 expression demonstrated 6.3 months median PFS (mPFS; n=119), rising to 12.5 months in treatment-naïve patients (n=62). Patients with 1-49% expression demonstrated mPFS of 3.3 months (n=161), and those with less than 1% mPFS of 2.3 months (n=76). Median overall survival (OS) has not yet matured for the high-expression sub-group, but it was 8.8 months for the other PD-L1 sub-groups below 50% expression. Median duration of response was comparable across the different sub-groups - 12.4 months for the high expression (50%), 10.3 months for 1-49% expression, and not reached for less than 1%.

TetraLogic and Merck to Collaborate on the Evaluation of Birinapant in Combination with KEYTRUDA(R) (pembrolizumab) in Solid Tumors

TetraLogic Pharmaceuticals Corporation and Merck announced that they have entered into an oncology clinical study collaboration. The companies will collaborate on a Phase 1 study to evaluate the safety and efficacy of birinapant, TetraLogic's SMAC-mimetic, in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with relapsed or refractory solid tumors. The study is expected to begin in late 2015. KEYTRUDA and birinapant target different elements of cancer's block against the immune system. TetraLogic's birinapant (TL32711) is a potent, bivalent SMAC-mimetic that binds with differential affinity to multiple members of the IAP family in order to re-establish the immune system's ability to kill abnormal cells via an extracellular TNF signal. Merck's KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2. The proposed collaboration is based on preclinical data that suggest SMAC-mimetics have the potential to enhance existing immuno-oncology agents, such as KEYTRUDA. Under the terms of the agreement, TetraLogic and Merck, through subsidiaries, will collaborate on an initial Phase 1 dose-escalation study of birinapant in combination with KEYTRUDA in patients with relapsed or refractory solid tumors. TetraLogic will sponsor and fund the study and Merck will provide KEYTRUDA. The companies have formed a Joint Development Committee to collaboratively oversee the conduct of the study. Results from the study will be used to determine the path for further clinical development of the combination.

Merck Announces Investigational Anti PD 1 Therapy, in Patients with Advanced Pleural Mesothelioma Presented at AACR Annual Meeting

Merck announced the first presentation of data investigating the use of pembrolizumab, the company's investigational anti-PD-1 therapy, in 25 patients with advanced pleural mesothelioma, a difficult-to-treat cancer of the lining of the lungs, abdomen and other organs. The early findings presented showed an overall response rate (confirmed and unconfirmed) of 28% with pembrolizumab in patients with tumours that expressed PD-L1. Additionally, 48% of patients had stable disease, resulting in a disease control rate of 76%. These data, from KEYNOTE-028, will be presented at the American Association for Cancer Research (AACR) Annual Meeting by Dr. Evan Alley, Abramson Cancer Center, University of Pennsylvania, and were part of the AACR official press program (abstract #CT103). This is the first data to be presented from KEYNOTE-028, Merck's innovative basket trial designed to evaluate the efficacy and safety of pembrolizumab in patients with 20 difficult-to-treat cancers. At the time of the analysis, 40% of patients (n=10/25) remained on treatment. Adverse events in the study were consistent with previously reported safety data for pembrolizumab. The most common treatment-related adverse events (occurring in greater than 20% of patients) were fatigue (24%) and nausea (24%). Two Grade 3 treatment-related adverse events occurred: ALT increased (n=1) and thrombocytopenia (n=1). Some patients experienced adverse events of special interest, including rash (n=4), ALT/AST increased (n=1), hypersensitivity (n=1) and iridocyclitis (n=1); two required a dose interruption (one because of ALT/AST increased, one because of iridocyclitis). No patients discontinued as a result of treatment-related adverse events, and there were no treatment-related deaths.

 

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