Less than 1% of the U.S. population uses cannabis for medical purposes on a regular basis. A key obstacle to mainstream acceptance of cannabis as medical treatment is the lack of clinical trials that demonstrate safety and efficacy of treatment outcomes. The FDA will not allow medical or health claims on cannabis products that have not been proven in clinical trials, which currently cannot be conducted on cannabis as it is considered a dangerous Schedule 1 substance. (The Jerusalem Post)
Report by Ahmed Enany from SoCal Bio outlines impact of NIH cuts on CA
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)
Allergan signs deal with Editas for their gene-editing-based eye treatments
Under a new research and development deal between Allergan and Editas Medicine, Inc., Allergan will get exclusive access and the option to license up to five of Editas’ experimental gene-editing-based eye treatments. Editas’ gene-editing technology is CRISPR, which is expected to revolutionize the treatment of genetic diseases. CRISPR “works as a type of molecular scissors that can trim away unwanted pieces of genetic material, and replace them with new ones.” (Reuters)
UCSD researchers 3D bioprint functioning blood vessels
Researchers from the University of California, San Diego, led by Professor Shaochen Chen, successfully 3D printed a framework of functional blood vessels, using a 3D bioprinting process. Almost all tissues and organs need blood vessels to survive. This is a big bottleneck in making organ transplants, which are in high demand but in short supply, and 3D bioprinting blood vessels can help bridge this gap. (3D Printing Industry)
San Diego’s Tocagen plans IPO to finance trials of gene therapy in brain cancer
Gene therapy developer Tocagen, a San Diego-based biotech, is preparing an initial public stock offering to finance clinical trials of its experimental treatment for high-grade glioma brain cancer. Tocagen filed the paperwork last week for an IPO that could raise up to $86 million. No gene therapies have yet been approved in the U.S. (Xconomy)
The present and future of genetic counseling: an interview with Emily Quinn, a certified genetic counselor. Part 1
Interview conducted by and article written by Tatsiana Verstak* Part 1: An overview of genetic counseling at St. Jude Children’s Research Hospital Genetic counselors are professionals who have specialized education in medical genetics and counseling to interpret genetic test results. They ultimately guide and support patients in making decisions regarding Read more
The present and future of genetic counseling: an interview with Emily Quinn, a certified genetic counselor. Part 2
Interview and article by Tatsiana “Tanya” Verstak* Part 2: The path to genetic counseling Tanya Verstak You mentioned you went to undergrad at UC Santa Cruz and you went to grad school in New York, what got you interested in becoming a genetic counselor? Emily Quinn I was very fortunate Read more
Clinical trial reform is urgently needed in oncology
We have tremendous opportunity to improve cancer treatment outcomes, based on advances in our understanding of malignant disease and the mechanisms of drug resistance. However, the current status of clinical cancer research falls short of what we need to improve the lives of people with cancer. (OncLive)
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
Reference:
- 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. azia@umail.iu.edu
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/
Adverse Events are underreported in targeted therapy trials
In a recent study, many trials leading to the approval of a targeted therapy were not fully transparent about the risk for adverse events (AEs), and most were deficient in reporting recurrent and late toxicities. Underreporting of AEs might be more frequent with targeted treatments than conventional chemotherapies. AEs associated with targeted agents persist longer may not be not fully captured by physicians. (Clinical Oncology)
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