The microbiome is the population of microscopic organisms that live in the digestive tracts of animals, including humans. Recent studies have identified new gut microbiome interventions to promote human health and combat disease. This article gives a brief history of microbiome research and outlines four main areas of ongoing research. (Medical x Press)
The FDA defines gene therapy as a medical technique that works to modify a person’s genes to treat or cure disease. Gene therapy represents a paradigm shift in the U.S. healthcare from chronic, often lifelong treatments to the potential for cure. There are currently 3 FDA-approved gene therapy products on the market, and nearly 2,600 gene therapy clinical trials are in progress or have been completed. (Pharmacy Times)
The inaugural Festival of Biologics USA is landing in San Diego on March 4th -5th 2019 (pre-conference day on March 3rd), and we want to make sure you know everything there is to know about this brand-new event.
The Festival of Biologics USA will be combining three high-level commercial events: The Americas Antibody Congress, The Word Immunotherapy Congress, and Clinical Trials USA, under one roof, with 200+ speakers, 600+ attendees and 60+ sponsors and exhibitors.
On April 20th, 2018, Tanya Verstak interviewed Guy Iannuzzi regarding his company Mentus and the development of biotechnology in San Diego as well as Biocom. About the interviee: Guy and Mentus market entrepreneurial and technology based companies and products. Their success is enabled by creative solutions driven by customer-centric strategic Read more
Iranian hackers with connections to the hacking organization the Mabna Institute stole research data that cost billions of dollars to acquire from hundreds of universities, academic journals, and private companies over the past four years. The cyberattack hit 144 U.S. universities and at least 36 private companies including one biotech.
San Diego Clinical Research Network (SDCRN) is organizing a program on “Top 10 life science trends to watch in 2018” for the first week in March, and we are looking for a venue and a sponsor for this program. Would you like to host this program at your workplace? Contact email@example.com for more information.
Relatively little is known about the different types of cells in the brain and what they do, much less about how they change in illness. The National Institutes of Health has launched the $250 million Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative Cell Census Network (BICCN) to discover and catalog the brain’s “parts list.” The BICCN aims to provide researchers with a comprehensive reference of the diverse cell types in human, monkey, and mouse brain, which is prerequisite to solving the mysteries of brain disorders such as schizophrenia, Alzheimer’s disease, and autism spectrum disorder. (National Institutes of Health)
According to a new report by Ahmed Enany, CEO of SoCalBio, the 20% cuts in NIH budget proposed by the Trump administration may put health research and jobs at risk. In 2016, NIH allocated most of its funds to extramural research grants — $24.83 billion out of a $32 billion total budget. Of all states, California got the most, with $3.7 billion or 15% of NIH extramural grants. Most of this goes towards basic and applied research at non-profit educational institutions and research hospitals, with the top-receiving CA organizations being UCSF, Stanford University, UCSD, UCLA, and Scripps. San Diego organizations winning the largest NIH grants were UCSD, Scripps, and Sanford Burnham Institute. The top winning investigators were Eric Topol, Dennis Burton, and Howard Feldman, and the top funding foci were digital health and translational science, Aids, and Alzheimers. (slideshare.net, Ahmed Enany)
Pediatric study requirements are included in the Pediatric Research Equity Act (PREA), which requires biopharma companies to study their products in children under certain circumstances, and the Best Pharmaceuticals for Children Act (BPCA). The new Research to Accelerate Cures and Equity (RACE) for Children Act will expand FDA’s authority to require companies to undertake pediatric study plans pursuant to PREA. (Regulatory Affairs Professionals Society)
Pembrolizumab increases the overall survival rate and reduces adverse events in patients with urothelial carcinoma
By Awais Zia
Urothelial carcinoma is a cancer of transitional epithelium that occurs in the urinary system including the renal pelvis, bladder, ureter, and/or urethra. Patients with urothelial carcinoma usually present with blood in the urine and frequency or urgency to urinate. Current management of metastatic urothelial carcinoma consists of first-line platinum-based chemotherapy, especially cisplatin. Cisplatin provides a median overall survival of 12 to 15 months. (Continue reading here.)
After cisplatin, second-line standard therapy consists of several drugs, and each have varied effects. These drugs include paclitaxel, docetaxel, and vinflunine. The median overall survival provided by second-line therapy is only about 6 to 7 months. This has led to investigations for a second-line therapy that is more effective than current regimens.1
In recent years, monoclonal antibodies have shown promise in combating cancer. New antibodies have been designed to prevent cancer cells from blocking the immune system, in turn allowing the immune cells to target cancer cells. An example of monoclonal antibodies that work as antitumor agents are PD-1inhibitors. Pembrolizumab is a humanized monoclonal IgG4K isotype antibody against PD-1 that binds to PD-1 receptor and prevents inhibitory signals in T cells, consequently allowing T cells to attack cancer cells. In phase 1 and phase 2 trials, pembrolizumab has shown antitumor activity in patients with advanced urothelial carcinoma. A phase 3 trial was conducted whose results were recently published in The New England Journal of Medicine. Pembrolizumab has shown to significantly increase the overall survival of patients with urothelial carcinoma as well as decrease the rate of treatment-related adverse events compared to other second-line therapy agents.1
KEYNOTE-045 was a randomized, open-label, international phase 3 trial. Patients 18 years or older with confirmed urothelial carcinoma that had progressed after platinum-based chemotherapy were eligible. A total of 542 patients were randomly assigned in a 1:1 ratio to receive either pembrolizumab or a choice of standard second-line chemotherapy (paclitaxel, docetaxel, or vinflunine). The primary endpoints were overall survival and progression-free survival. The secondary endpoints were the objective response rate, duration of confirmed response, and safety. Patients who took pembrolizumab showed a longer overall survival than patients who took standard chemotherapy (10.3 months vs. 7.4 months; hazard ratio for death, 0.73; P=0.002).
There was no significant difference in the duration of progression-free survival between the pembrolizumab group and the standard chemotherapy group. The objective response rate was significantly higher in the pembrolizumab group than the chemotherapy group (21.1% vs. 11.4%, P=0.001). The percentage of patients with a duration of response of at least 12 months was 68% in the pembrolizumab group and 35% in the standard chemotherapy group. There was a lower rate of treatment-related adverse events in the pembrolizumab group than the standard chemotherapy group (60.9% vs. 90.2%). The most common treatment-related adverse events were pruritis (19.5% of patients), fatigue (13.9%), and nausea (10.9%). Four deaths occurred in the pembrolizumab group that were attributed to treatment.1
These results suggest that pembrolizumab is an effective second-line agent that can be used to treat patients with advanced urothelial carcinoma previously treated with platin-based therapy. Pembrolizumab increased the overall survival by approximately 3 months and was less toxic than standard second-line chemotherapy. Although increased survival by 3 months may not appear high, it is still a meaningful increase for patients. Many patients with cancer get diagnosed suddenly, which comes as a shock in their lives. The period between treatment and potential recovery or death can be a painful and difficult period for many patients. Lengthening the overall survival time by even a few months can be comforting for patients as well as their families who may have to go through as much pain as patients themselves.1
The use of pembrolizumab in the clinic compared with standard second-line therapy should proceed with caution. Although pembrolizumab was less toxic than standard therapy, its use was associated with several adverse events including pruritis, fatigue, and nausea in certain patients. Moreover, four deaths were attributed to pembrolizumab use. Proper dosage and constant monitoring of patients may be necessary when administering pembrolizumab in the clinic. A patient’s past medical history and current problems should also be considered.1
- Bellmunt, J, de Wit R, Vaughn, DJ, et al. “Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma.” N Engl J Med. DOI: 10.1056/NEJMoa1613683.
Awais is a freelance medical writer and contributor to Clinical Research Currents, living in Rockville, MD. firstname.lastname@example.org
Citation: Zia, Awais. Pembrolizumab increases the overall survival rate and reduces adverse events in patients with urothelial carcinoma. Clinical Research Currents March 1, 2017. http://www.clinicalresearchcurrents.com/