We continue to track the immuno-oncology (I/O) space closely and have recently made some updates to our prior analysis (here: http://bit.ly/2bcv1f5) of cancer immunotherapy biomarkers in clinical trials, adding >65 trials and hundreds of biomarkers. As a reminder, this clinical trial analysis focuses on I/O-related clinical trials that have listed “laboratory biomarker analysis” as one of the interventions or which mention the use of some kind of analytical technology (e.g., IHC, sequencing, ELISA) for the purpose of biomarker analysis in the trial description. See the interactive Tableau dashboard below to browse and filter the results (click on the buttons at the top, the biomarker circles, or the trial information in the table at the bottom to filter the data as desired; use Crtl + Click to make multiple selections):

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While, due to the nature of information provided in clinicaltrials.gov, the search results do not cover the entire universe of I/O biomarkers (e.g., many of Merck’s KEYNOTE and BMS’ CheckMate trials do not provide biomarker information in the trial description) this analysis still yields some interesting insights into I/O biomarker trends. Here are some of the insights we have gleaned from the analysis to-date:

• Over half of all trials assessed to date include some kind of analysis for the purpose of monitoring a patient’s immune response or response to therapy. These trials employ a variety of different technologies, including flow cytometry, ELISA, and ELISPOT/Interferon-Gamma Release Assays (IGRAs). We believe that immune monitoring represents an attractive market opportunity as these assays are more likely to be conducted multiple times over the course of a patient’s treatment.
• IHC and flow cytometry, combined, comprise the vast majority of technology share in trials that specify a particular technology, accounting for ~50% and ~25% of biomarker mentions, respectively. Sequencing, however, has experienced the highest growth in the last 2 years, with the cumulative number of I/O biomarkers being explored utilizing sequencing growing by >250% annually over the past two years. This growth number is likely an underestimate, as a large portion of trials looking at nucleic acid biomarkers do not specify a technology and could also be utilizing sequencing-based techniques.
• Tumor tissue is the most common and fastest growing sample type for I/O biomarker analysis. However, peripheral blood cells and soluble peripheral blood markers, combined, represent an almost equal number of biomarker mentions as tumor tissue through 2016 (220 vs. 259), suggesting a potentially substantial opportunity for liquid biopsy-based assays. Interestingly, the majority of the soluble blood biomarkers are proteins, rather than genetic markers, which typically receive more attention in the context of liquid biopsies.
• While PD-L1 remains the most popular biomarker (it is being explored as a biomarker in 63 out of the 164 trials analyzed), genomic mutation profiling is being explored in the largest volume of patients in advanced (phase 2/3 and phase 3) clinical trials, including ~2,700 patients across 4 phase III trials.

In 2016 we learned how important biomarkers can be in driving the I/O market landscape, so we’ll be keeping a close eye on biomarker and Dx developments in 2017. Check back in periodically for more updates and analysis.Note: In addition to the dashboard embedded here, we have also developed other dashboards for biomarker distribution by enrollment volume, biomarker, technology, and sample-type trends, the trial sponsor landscape, and a breakdown of trials and biomarkers by cancer indication. See the sample images below:

If you are interested in accessing the complete analytical tool with all dashboards, please fill out the form below and we will follow up with you via email:DeciBio will be at JPM 2017! We would be happy to meet and chat about immuno-oncology, diagnostics, or any other topic in the life science industry. Shoot me an email if you would be interested in setting up a time to meet: aijian@decibio.com.

Author:Andrew Aijian, Project Leader at DeciBio Consulting, LLC,Connect with Andrew on LinkedIn:https://www.linkedin.com/in/andrew-aijianDisclaimer: Some of the companies listed above may be DeciBio Consulting clients or customers.About DeciBio ConsultingDeciBio Consulting is a market research and strategy consulting firm focused on the global research tools, clinical diagnostics, and medical device industries. Our mission is to provide the market intelligence and strategic insights that drive disruption and innovation in the research tools, clinical diagnostics, and medical device markets. We work with clients ranging from start-ups to Fortune 500 companies, conducting custom market research and strategy assessment across all areas of the life sciences markets. Click here for more information about our consulting services.