State of Immunotherapy 2014: Definiens Predicts the Top Four Trends That Will Shape the Future of Immunotherapy in Cancer Care

MUNICH, GERMANY - Jun 4, 2014 - Definiens, the global leader in Tissue Phenomics™ for discovery and diagnostics development in oncology, today released its predictions on the four trends that will shape the future of oncology immunotherapy in 2014. 

“The four trends highlighted demonstrate why this is a transformative moment in the field of cancer immunotherapy. We’re at the beginning of some incredible advancements in oncology diagnostics, prognostics and treatments. Definiens is committed to supporting these efforts through its unique Tissue Phenomics approach,” said Thomas Heydler, CEO of Definiens. “Leveraging all of the spatial and morphological tissue data to better understand the tumor microenvironment is a prerequisite to developing immunotherapy treatments that will drive personalized medicine and make a real difference in patients’ lives.”

1.Immune Status and the Immunoscore™ Emerge as Important Factors

Recent research in immunotherapy has revealed the prognostic and predictive value of a patient’s immune status. Studies in colorectal cancer led by prominent immunologist Professor Jérôme Galon indicate the significance of immune status - classified in these studies as a patient’s Immunoscore - for determining clinical outcomes and long-term treatment success. Immune status is derived from a complete analysis of the number, type and location of tumor infiltrating lymphocytes in the tumor microenvironment. Historically these aspects of the tumor microenvironment have been difficult to accurately measure, but Galon used solutions from Definiens to overcome the challenge. Research suggests that in addition to predicting the likelihood of tumor recurrence, immune status is an invaluable tool for improving patient stratification in clinical trials and identifying predictive biomarkers, both of which are critical to the development of effective immunotherapeutic treatments. With the Society for Immunotherapy of Cancer currently leading global efforts to validate the Immunoscore, this approach is poised to not only significantly transform immunotherapy research but routine clinical practice as well.

2. New Checkpoint Inhibitors Hold Promise for Long-Term Results

Following FDA approval of ipilimumab for the treatment of metastatic melanoma in 2011, checkpoint inhibitors that target CTLA-4 pathways, which induce the body’s immune system to recognize and respond to cancer without triggering an autoimmune response, have become some of the most heralded approaches to cancer immunotherapy. Excitement around these checkpoint inhibitors is due to the fact that patients who respond to treatment experience durable, long-term results. Not surprisingly, a number of clinical trials testing the effectiveness of ipilimumab for a broad range of cancer types, including lung, prostate and pancreatic cancer, are now underway. In addition to CTLA-4 inhibitors, explorations of PD-1 and PD-L1 pathways have gained significant ground as an alternative method of mitigating the ways in which cancer takes advantage of the immune system’s natural checkpoints to silence the body’s T cells. In spite of their impressive results, determining patient response remains a challenge, making the use of quantitative image analysis for the identification of relevant prognostic and predictive tissue biomarkers vital to the advancement of these types of immunotherapies. 

3. Combination Treatments to Gain Momentum

Current research indicates that immunotherapeutic treatments may be most effective when used in combination. For example, a clinical trial underway at the University of California San Francisco is examining the efficacy of administering sipileucel-T, a form of adoptive T cell therapy that received FDA approval in 2010 for the treatment of advanced stage prostate cancer, in conjunction with a CTLA-4 checkpoint inhibitor. Similarly, studies at the Dana-Farber Institute examining concurrent targeting of PD-1 and CTLA-4 inhibitors for the treatment of melanoma have demonstrated positive results in a substantial number of patients.

The deployment of different types of checkpoint inhibitors in tandem provides a glimpse of what some of the most powerful treatments may eventually look like. Moving forward, quantitative image analysis can provide a more comprehensive understanding of immune response and help identify tissue biomarkers associated with combination therapy; two of the most critical elements for the development of safe and effective immunotherapeutic treatments.

4. Prognostic and Predictive Biomarkers to Become the Gold Standard

At the clinical level, researchers continue to grapple with determining why some patients respond to specific types of immunotherapies while others do not. As a result, identifying markers that can help predict responses to treatment remains a top priority. For example, in addition to developing treatments that effectively mitigate PD-1 and PD-L1 pathways, recent research presented at the 2014 American Association for Cancer Research’s (AACR) Annual Meeting indicates the effectiveness of using PD-L1 as a predictive marker of response to the PD-1 checkpoint inhibitor MK-3475 in patients with melanoma and NSCLC. The use of PD-L1 to gauge responsiveness to treatment is indicative of a larger trend in the field to identify immune-based biomarkers that can substantially improve patient stratification, advance the overall success of clinical trials and drive the development of future treatments with the potential for widespread clinical adoption.

“The widespread adoption and long-term success of specific immunotherapies will depend upon treatment decisions that can be clinically substantiated,” said Dr. Ralf Huss, Chief Medical Officer of Definiens. “The Definiens Tissue Phenomics platform provides researchers with a big data approach to extract and analyze all relevant data from individual patient tissue samples in order to develop treatments based on the strongest possible prognostic foundations. With the tools available to identify effective tissue biomarkers, there can be little doubt that the field of immunotherapy is poised for significant growth in 2014.”

About Definiens

Definiens is the global leader in Tissue Phenomics™ for discovery and diagnostics development in oncology and provides image analysis solutions for life sciences. Definiens' technology provides detailed tissue biomarker readouts from slide images and enables the correlation of this information with other key clinical or genomic information, an approach known as Tissue Phenomics™. Definiens helps pharmaceutical and biotechnology companies, research institutions, clinical service organizations and pathologists to generate new knowledge and support better decisions in research, diagnostics and therapy.

Definiens’ vision is to open new fields of research, to contribute to development of personalized medicine, and to significantly improve the quality of patients' lives. Definiens is headquartered in Munich, Germany and has its North American headquarters in Carlsbad, CA. Further information is available at www.definiens.com.