Mon, Apr. 27, 5:40 PM
Mon, Apr. 27, 5:30 PM
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Mon, Apr. 27, 4:34 PM
Mon, Apr. 27, 3:30 PM
- Two Phase 3 clinical trials evaluating Tetraphase Pharmaceuticals' (TTPH -5.1%) lead product candidate, eravacycline, show positive results for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
- The first study, IGNITE-1, compared eravacycline to Merck's (MRK -1.1%) Invanz (ertapenem) for the treatment of cIAI. It achieved the primary endpoint of statistical non-inferiority (no worse than) of clinical response at the test-of-cure (TOC) visit. In the microbiological intent-to-treat (micro-ITT) population (n=446) 86.8% of patients receiving eravacycline achieved a clinical cure compared to 87.6% of patients receiving ertapenem (FDA criteria). In the clinically evaluable population (n=477) 92.9% of patients receiving eravacycline achieved a clinical cure versus 94.5% of patients receiving ertapenem (EMA criteria). These results were first reported in December.
- In the lead-in portion of the second study, IGNITE-2, both IV-to-oral dosing regimens of eravacycline (1.5 mg/kg followed by 200 mg or 250 mg) compared favorably with levofloxacin, a broad spectrum antibiotic, for the treatment of cUTI. The primary endpoint, per the FDA's criteria, was the responder rate (defined as both clinical cure and successful microbiological outcome) in the micro-ITT population. The responder rates for 200 mg (n=24), 250 mg (n=28) and levofloxacin (n=23) were 75.0%, 64.3% and 56.4%, respectively. In the microbiologically evaluable population, the primary endpoint was the microbiological response per the EMA's criteria. The respective responses for levofloxacin isolates (n=24) were: 83.3%, 72.7% and 42.9%. Based on these data, the 200 mg dose will be used for the pivotal portion of the Phase 3 that is currently underway.
- The company expects to submit its regulatory applications by the end of the year.
- The data were presented at this week's 25th European Congress of Clinical Microbiology and Infectious Diseases in Copenhagen, Denmark.
- Previously: Tetraphase antibiotic non-inferior to ertapenem in Phase 3 study (Dec. 17, 2014)
Sat, Apr. 25, 7:05 PM
- Merck (NYSE:MRK) announces the presentation of results from two Phase 2 studies of its investigational HCV combination therapy, grazoprevir/elbasvir (G/E).
- The first trial, C-SALVAGE, assessed 12 weeks of G/E therapy plus ribavirin (RBV) in HCV-1 patients who previously failed treatment with peginterferon and RBV combined with a direct-acting antiviral (DAA) (boceprevir, simeprevir or telaprevir). 34 patients (43%) of the 79 who received at least one dose of G/E were cirrhotic. The overall cure rate (sustained virologic response 12 weeks after treatment or SVR12) was 96% (n=76/79). The cure rate in patients with compensated cirrhosis was 94% (n=32/34). Three patients relapsed after the completion of therapy. All three had resistance-associated variants at baseline.
- The second trial, C-SWIFT, was a proof-of-concept study assessing G/E + Gilead's (NASDAQ:GILD) Sovaldi (sofosbuvir) over shorter treatment durations in treatment-naive HCV-1 and HCV-3 patients with or without cirrhosis. The cure rates (SVR12) were: HCV-1 non-cirrhotic/4 weeks: 33% (n=10/30); HCV-1 non-cirrhotic/6 weeks: 87% (n=26/30); HCV-1 cirrhotic/6 weeks: 80% (n=16/20); HCV-1 cirrhotic/8 weeks: 94% (n=17/18); HCV-3 non-cirrhotic/8 weeks: 93% (n=14/15); HCV-3 cirrhotic/8 weeks: 100% (n=14/14); HCV-3 cirrhotic/12 weeks: 91% (n=10/11).
- The data were presented at the 50th Annual Congress of the European Association for the Study of the Liver in Vienna, Austria.
Sat, Apr. 25, 5:48 PM
- Preliminary data from a Phase 3 study, RUBY-1, evaluating AbbVie's (NYSE:ABBV) Viekirax (ombitasvir/paritaprevir/ritonavir) + Exviera (dasabuvir), with or without ribavirin, for 12 or 24 weeks in treatment-naive, non-cirrhotic HCV-1 patients with severe renal impairment (stage 4 or 5), including those on hemodialysis, showed a 100% SVR4 rate (n=10/10) (sustained virologic response four weeks after treatment). Enrollment is 20 patients, but only half had reached week 4 post treatment at the data cutoff.
- The primary endpoint of the trial is the percentage of patients achieving SVR12. Cohort 1 consists of 20 patients without cirrhosis while cohort 2 has 20 patients with or without compensated cirrhosis.
- The data were presented at the 50th Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria.
- Related tickers: (NASDAQ:ENTA) (NASDAQ:GILD) (NYSE:MRK) (NYSE:BMY)
Fri, Apr. 24, 9:05 AM
- At the Liver Meeting in Europe, Merck (NYSE:MRK) presented data from its ongoing C-EDGE pivotal Phase 3 study evaluating its HCV combination of grazoprevir/elbasvir (100mg/50mg) in patients with genotypes 1, 4 or 6.
- Overall, treatment-naive patients treated with the combo for 12 weeks without ribavirin (RBV) showed a cure rate (sustained virologic response 12 weeks after therapy or SVR12) of 95% (n=299/316). Treatment-naive patients co-infected with HIV treated for 12 weeks, without RBV, also showed a cure rate of 95% (n=207/218).
- Treatment-experienced HCV patients treated with the combo, with and without RBV showed cure rates of 94% (n=98/104) and 92% (n=97/105), respectively. Treatment-experienced HCV patients treated for 16 weeks, with and without RBV, showed cure rates of 97% (n=103/106) and 92% (n=07/105), respectively.
- Cure rates in cirrhotic patients ranged from 89 - 100%; non-cirrhotic: 93 - 97%; genotype 1a: 90 - 95%; genotype 1b or other g-1: 96 - 100%; genotype 4: 60 - 100% and genotype 6: 75 - 100%.
- The results were presented at the 50th Annual Congress of the European Association for the Study of the Liver in Vienna, Austria.
- Related tickers: (NASDAQ:GILD) (NYSE:ABBV) (NYSE:JNJ) (NYSE:BMY)
Thu, Apr. 23, 11:55 AM
- An interim analysis of a Phase 2/3 trial, C-SURFER, evaluating Merck's (MRK -0.1%) investigational once-daily regimen of grazoprevir and elbasvir in patients with advanced kidney disease infected with the HCV-1 virus showed a 99% (n=115/116) cure rate (SVR12) after 12 weeks of treatment.
- The data will be presented at this week's 50th Annual Congress of the European Association for the Study of the Liver in Vienna, Austria.
- Grazoprevir is an NS3/4A protease inhibitor and elbasvir is an NS5A complex inhibitor. Several weeks ago, the FDA designated the combo a Breakthrough Therapy for the treatment of HCV-1 in patients with end-stage renal disease on hemodialysis and patients with chronic HCV-4 infection.
- Breakthrough Therapy status provides for more intensive FDA guidance on development, the involvement of more senior managers and a rolling review of the New Drug Application (NDA).
- Previously: Merck HCV combo med tagged a Breakthrough Therapy for HCV-4 and HCV-1 dialysis patients (April 8)
- Related tickers: (GILD +0.4%)(ABBV -1.6%)
Wed, Apr. 22, 8:50 AM| Wed, Apr. 22, 8:50 AM | 14 Comments
Mon, Apr. 20, 12:04 PM
- Merck (MRK +1.9%) submits its supplemental New Drug Application (sNDA) to the FDA seeking approval for the use of Keytruda (pembrolizumab) for the treatment of advanced non-small cell lung cancer whose disease has progressed on or after platinum-based chemo and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present. The submission was based on data from the KEYNOTE-001 study.
- Keytruda is currently cleared for the treatment of melanoma.
Mon, Apr. 20, 9:00 AM
- Merck (NYSE:MRK) and TetraLogic Pharmaceuticals (NASDAQ:TLOG) will collaborate on a Phase 1 study to evaluate the former's Keytruda (pembrolizumab) with the latter's birinapant in patients with relapsed or refractory solid tumors. The trial is expected to commence later this year.
- Keytruda and birinapant target different elements of cancer cells' block of the immune system. Birinapant is a bivalent SMAC-mimetic (Second Mitochondrial Activator of Caspases) that binds to members of the IAP (Inhibitor of Apoptosis Proteins) family that re-establishes the immune system's ability to kill abnormal cells via the TNF (Tumor Necrosis Factor) pathway. Keytruda blocks the interaction between PD-1 (programmed death receptor-1) and its ligands, PD-L1 and PD-L2. Preclinical studies suggest that SMAC-mimetics may enhance the action of immuno-oncology agents like Keytruda.
- Under the terms of the agreement, the companies will collaborate on a Phase 1 dose-escalation study. TetraLogic will sponsor and fund the study and Merck will provide Keytruda. Future development will depend on the results from the study.
Mon, Apr. 20, 8:10 AM
- At the American Association for Cancer Research Annual Meeting in Philadelphia, Merck (NYSE:MRK) presented data from three studies of its PD-1 inhibitor Keytruda (pembrolizumab).
- Early findings from the KEYNOTE-028 study in patients with advanced pleural mesothelioma show an overall response rate of 28% in patients with tumors that expressed PD-L1. The disease control rate was 76% (includes the 48% of patients with stable disease). These were the first data presented from the company's basket trial that is evaluating Keytruda in patients with 20 difficult-to-treat cancers.
- The Phase 3 KEYNOTE-006 study comparing Keytruda to Bristol-Myers Squibb's (NYSE:BMY) Yervoy (ipilimumab) in patients with unresectable advanced melanoma was stopped early after the data showed that Keytruda was statistically superior to ipilimumab in progression-free survival, overall survival and overall response rate. Merck plans to submit a supplemental Biologics License Application (sBLA) to the FDA for the first line line treatment of advanced melanoma by mid-year.
- Data from the Phase 1b KEYNOTE-001 study in patients with naive and previously treated advanced non-small cell lung cancer showed an overall response rate (ORR) of 45.4% in patients with at least 50% of tumor cells positive for PD-L1 expression (n=73), an ORR of 16.5% in patients with 1 - 49% of PD-L1-expressing tumor cells and an ORR of 10.7% in patients with <1% of PD-L1-expressing tumor cells. The company submitted an sBLA in December for this indication, tagged a Breakthrough Therapy by the FDA.
Tue, Apr. 14, 2:05 PM
- The Phase 3 segment of a Phase 2/3 trial, called STRIVE, evaluating the Ebola vaccine candidate, rVSV-ZEBOV-GP, has been initiated in Sierra Leone. The study will involve 6,000 health and front-line workers in several West African countries in the Basse Guinee region, which dealt with the most Ebola infections. The study in Guinea commenced a couple of weeks ago.
- rVSV-ZEBOV-GP was originally developed by the Public Health Agency of Canada. It licensed it to NewLink Genetics (NLNK) who, in turn, licensed it to Merck (MRK +2%).
- Previously: Phase 3 trials for Merck-NewLink Ebola vaccine start this week in Guinea (March 5)
Wed, Apr. 8, 9:56 AM
- Patient enrollment has begun in a Phase 1/2 study, called KEYNOTE-046, evaluating the combination of Advaxis' (ADXS +0.2%) Lm-LLO immunotherapy, ADXS-PSA, and Merck's (MRK +0.8%) PD-1 inhibitor Keytruda (pembrolizumab) for previously treated metastatic castration-resistant prostate cancer.
- The companies initiated the trial after preclinical studies of the combination showed a synergistic anti-tumor response.
- KEYNOTE-046 will enroll ~51 patients and will assess the safety and efficacy of ADXS-PSA as monotherapy and in combination with Keytruda. Part A of the trial is a dose escalating study to establish the maximum tolerated dose of ADXS-PSA alone. Part B will be a dose escalating study of the combination, followed by an expansion cohort phase. The primary endpoint is safety and tolerability. Secondary endpoints are anti-tumor activity and progression-free survival (PFS).
- ADXS-PSA is an immunotherapy that targets prostate-specific antigen (PSA). It secretes PSA fused to the immunostimulant tLLO to drive a cellular immune response to PSA. Keytruda is a humanized monoclonal antibody that binds to the PD-1 receptor on the surface of cancer cells, blocking the actions of PD-L1 and PD-L2, which then enables the immune system to attack and kill the cancer cells.
Wed, Apr. 8, 8:23 AM
- AbbVie (NYSE:ABBV) announces that 29 abstracts from its HCV programs have been accepted for presentation at the International Liver Congress in Vienna, Austria April 22 - 26.
- Data to be presented include sub-analyses from VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) plus EXVIERA (dasabuvir tablets), Phase 3b studies, including a direct comparison of the company's three direct-acting antiviral treatment with telaprevir-based therapy, Phase 2/3 studies assessing AbbVie's combination treatment in HCV-1 and HCV-4 and Phase 1s of ABT-493 and ABT-530.
- Preliminary results from a Phase 2b trial (n=79) evaluating ABT-493 and ABT-530 in non-cirrhotic HCV-1 patients show a sustained virologic response at four weeks post treatment (SVR4) of 99% (n=78/79). The results include GT1a and GT1b, treatment-naive and pegylated-interferon and RBV prior null responders. Data from this study will not be presented at ILC but will be released at future medical meetings.
- Related tickers: (NYSE:MRK) (NASDAQ:GILD)
Wed, Apr. 8, 7:58 AM
- The FDA designates Merck's (NYSE:MRK) investigational single tablet HCV regimen, grazoprevir/elbasvir, a Breakthrough Therapy (BTD) for the treatment of patients with chronic HCV genotype 4 infection and for the treatment chronic HCV genotype 1 infection in patients with end stage renal disease on hemodialysis.
- In October 2013, the FDA granted BTD status for grazoprevir/elbasvir for the treatment of chronic HCV-1 but rescinded it in January 2015. BTD status provides for more intensive guidance from the FDA, the involvement of more senior managers and a rolling review of the New Drug Application (NDA).
- Separately, Merck will be presenting 14 abstracts from studies evaluating grazoprevir/elbasvir at the upcoming International Liver Congress in Vienna, Austria April 22 - 28.
- Related tickers: (NASDAQ:GILD) (NYSE:ABBV)
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