Immuno-Oncology Clinical Development
Moving novel therapies forward
White Paper
Nov 29, 2018
This white paper examines the discipline of immuno-oncology now and into the future – and ultimately focuses on how IQVIA is empowering the oncology community to advance the science and outcomes of cancer care through its deep bench of domain expertise, innovative solutions and application of Human Data Science.

The field of immuno-oncology is undergoing a period of intense innovation. In 2017, the FDA approved 46 novel drugs – more than double the 2016 figure. Among these were two chimeric antigen receptor (CAR)-T cell therapies, and several drugs that inhibit immune checkpoints. These represent new, powerful treatment options for cancer patients worldwide. However, this burst of innovation is resulting in an overcrowded market – especially as combination therapies increasingly become the standard of care – which complicates the landscape for sponsors of new therapies. This white paper examines the discipline of immuno-oncology now and into the future – and ultimately focuses on how IQVIA is empowering the oncology community to advance the science and outcomes of cancer care through its deep bench of domain expertise, innovative solutions and application of human data science.

Introduction: Immunooncology landscape and challenges

Cancer is a chronic immunologic disease. Tumors express tumor antigens; these are recognized by the immune system, which eliminates many early tumors. However, tumors have multiple mechanisms to evade the immune system, including expression of molecules that inhibit immune response.

Cancer has been progressively redefined over the past 20 years, with increased biomarker-based segmentation and greater complexity.Therapy options for multiple tumor types have increased, adding to treatment complexity, both in terms of diverse mechanisms of actions as well as the number of drugs for each mechanism of action (MoA) class.

The pace of development has been exceptionally fast in the last decade due to a combination of factors, including an increasing focus on targeted drug development based on biomarker segmentation and favorable regulatory policies such as the introduction of “breakthrough therapy” designations. Currently, multiple agents with similar MoA are available, presenting a complex situation for clinicians with limited clinical data directly comparing newer treatments with established ones.

 

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