Ticking Boxes: Immuno-Oncology Trials Checklist

By Elizabeth Koury and Jeff Mayhew, LabConnect

This article is taken from European Pharmaceutical Contractor February 2018, pages 12-15. © Samedan Ltd

With the advent of novel immuno-therapeutic approaches to cancer, the world has entered a new stage of medicine. Rather than targeting cancer cells directly with traditional tools like chemotherapy or radiation, immunotherapy seeks ways to use the body’s own immune system to eradicate or inhibit the growth of cancers.

The field of immuno-oncology (IO) focuses on determining how to activate pre-existing immune cells to attack cancerous targets. Monoclonal antibody therapies have shown to be successful in many indications and continue to be an effective and viable approach to treating cancer.

Perhaps the most groundbreaking and rapidly expanding modality of IO is the development of the utilization of checkpoint inhibitors. Though the industry is just scratching the surface of its promise, checkpoint inhibitors have profound implications on the future of oncological therapies, revolutionizing the research industry. Checkpoint inhibitor therapies are able to span across cancer types and stages, providing hope even in the most despairing of circumstances.

Because of its promising outcomes, IO is a significant and growing segment of clinical research, but one that does not come without challenges. Aside from the R&D of these therapies, identifying the most efficacious treatment regimen for each indication poses numerous challenges. As a result, combination studies have increased dramatically, as have the volume of studies, due to the potential of efficacy of one therapy in multiple indications. Studies have become fast-paced and complex, requiring appropriate support from the beginning to the very end of all studies, as the race to the market and the race to save lives is in the balance.