Foundations laid by important cancer biology and immunology research throughout the last decades have led to game-changing clinical breakthroughs in the field of immuno-oncology. However, a deep understanding of the intricate workings of the anti-tumor immune response is required to fully harness and apply the power of immuno-oncology, and this is still a work-in-progress. With mechanisms still partially veiled and hypotheses emerging from all angles, one thing is clear – immuno-oncology is complex and this has brought new challenges to all corners of drug development, including clinical biomarker testing. This white paper highlights some of the challenges associated with the diverse clinical biomarker requirements of immuno-oncology clinical trials. The paper also describes how Q2 Solutions’ laboratories have worked with biopharma sponsors to bring key research tools – including anatomic pathology, flow cytometry and genomics – into immuno-oncology clinical trials. Finally, the paper examines the potential for the development of companion diagnostics.
Linda Robbie, Ph.D., Senior Director, Biomarkers and Global Translational Science Laboratory, Q2 Solutions
Radha Krishnan, MD, Chief Pathologist and Senior Medical Director, Q2 Solutions
Patrick Hurban, Ph.D., Senior Director and Global Head, Translational Genomics, Q2 Solutions
Alistair J. Watt, Ph.D., Director, Translational Science Laboratory, Europe, Q2 Solutions