The rise of immunotherapy has been meteoric — there are now well more than 1,000 immuno-oncology (IO) trials ongoing according to clinicaltrials.gov. Finding and enrolling the appropriate patients for these potentially revolutionary treatments has presented a profound challenge, one that was recently covered in the aptly titled New York Times article: A Cancer Conundrum: Too Many Drug Trials, Too Few Patients. Another piece of the puzzle is clinical trial design, which can be especially elaborate when testing combination treatments in IO. Exacerbating these issues, IO trials are an increasingly competitive race to market. There is great value assigned to reducing development times and being the first drug approved within a class or for a specific indication.
This blog article discusses the current state of immuno-oncology studies, strategies for enhancing patient recruitment, the role of companion diagnostics and solutions for dealing with the complexity of IO combination studies. Continue reading
The majority of today’s approved companion (and complementary) diagnostics (CDx) support personalized medicine efforts in oncology, a testament to researchers’ growing knowledge regarding the genetic pathways impacted in various cancers. That understanding increases our ability to convert such knowledge of biology into treatments that specifically target disease based on a tumor’s genetic makeup. This has led to significantly improved outcomes for many patients.
But can we leverage the knowledge of the biology of other disease states along with the appropriate technical progress into successful CDx expansion beyond oncology? Given that nearly 50% of all compounds in clinical development are dropped for lack of efficacy, CDx may represent a viable approach to improve this statistic and boost the efficiency of drug development efforts. Promising clinical areas where CDx may play an important role include immunology, rare and orphan diseases, and neurodegenerative diseases such as Alzheimer’s disease. Continue reading
In previous posts on this blog, our scientists have described the current state of precision medicine, particularly how it relates to companion diagnostics (CDx) and immuno-oncology. As an enterprise, we have been focused on this area of medicine essentially from the beginning, more than 20 years ago. LabCorp Diagnostics developed the clinical trials assay and served as the central lab for the testing of HER2-positive breast cancer during the development of trastuzumab. The company provided analytical testing data for the associated immunohistochemistry laboratory test resulting in the first companion diagnostic approved by the FDA. More recently, Covance was instrumental in supporting the drug development efforts for pembrolizumab, the therapy used successfully to treat former President Jimmy Carter’s melanoma, and its associated companion diagnostic. Continue reading
The NIH defines precision medicine as “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person1.” In cancer patients, we can rephrase the definition to “through detailed understanding of a cancer’s biology, providing the right drug, for the right patient, at the right time.”
In order to identify the correct drug, biomarkers are used to identify patients that can be treated with the appropriate therapy for their cancer. The FDA defines biomarkers as “a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions2.” Great strides have been made in the discovery and validation of biomarkers in drug development. Continue reading
Chinese biopharmaceuticals are expanding development beyond generics to focus on producing more personalized medicine, novel therapies, biomarkers and companion diagnostics. Steven Anderson, PhD, chief scientific officer at Covance, recently discussed his thoughts on biomarkers and precision medicine in China’s drug development and translational medicine landscape.
An emerging focus on biomarkers
“Efficacy of a drug therapy can vary widely and adverse effects can be common, but these parameters are not easily predicted,” explained Anderson. “That’s why biomarker-based, targeted treatments can guide therapy decision-making and better identify those individuals most likely to benefit.”
Drug developers are increasingly incorporating a CDx development (companion diagnostic) strategy into their programs to deliver safer, more effective and appropriate therapies to the right patients. While the end result can be significantly beneficial for patients, and development partners, the path from analytical and clinical validation to demonstrating clinical utility and obtaining regulatory approval is often challenging. It requires a comprehensive understanding of clinical trial design, regulatory submission strategies both for the therapy and the diagnostic assay, and also a line of sight for successful commercialization. Continue reading