Advances in immunotherapy have dramatically changed the landscape for cancer researchers. With significant improvements in overall survival and recurrent free survival in some of the deadliest cancers, lives have been extended by years for some patients while other patients have not experienced benefit from immunotherapy treatment. For some cancer indications, such as non-small cell lung cancer, the FDA approved companion diagnostic test for PD-L1 by immunohistochemistry has predictive value on patient response. However, the test is not a perfect indicator of response as some PD-L1 negative patients will respond to therapy and, conversely, some PD-L1 positive patients will not. At the same time, the number of clinical trials examining immunotherapy and combination therapies with immunotherapy as a backbone has exceeded 1000 in 2017. The possibility of combination therapy brings many questions to light for the researcher and ultimately the physician on which therapy to choose, for how long, in what order and what potential combination. With these questions, comes the increasing need for predictive tests that can lead the physician to the right therapy at the right time.Read More
In recent years there have been several potentially life-saving medications approved for cancer treatment, including targeted molecular entities and biologics such as Opdivo (nivolumab) and Keytruda (pembrolizumab). Oncology drugs remain a pharmaceutical priority and investments into cancer account for 30% of all pre-clinical and phase 1 clinical development expenditures. There is an impressive list of close to 800 drugs and vaccines currently in the industry-wide development pipeline, many with promising results in early-stage clinical trials. However by historical measures only 10% or fewer of these drugs will ever make it through FDA approval and become part of routine patient care.Read More
Late phase failure is a huge challenge for pharmaceutical companies running clinical trials. In fact, only 65% of phase III trials successfully lead to new drugs being approved (1). The primary reason behind this high failure rate is efficacy, with more than 60% of those phase III failures caused by poor response rates in large patient groups (2).
To address these low efficacy rates, more pharmaceutical companies have begun focusing their resources on solutions which ensure more confident go/no-go decision making. They recognize that the ability to select the right drug candidates for phase III trials and develop companion diagnostics for better patient stratification are the only way to gain this confidence and ultimately increase the efficacy of their drugs during clinical trials.Read More