Emerging Trends in Immuno-Oncology Trial Design

Recent approvals of multiple immune checkpoint inhibitors, which help the body target and combat cancer cells, has both changed the standard of care in different cancers and brought cancer research to a critical juncture. “When you want to design a clinical trial and observe benefit for a new drug, you have to take into account all the other treatments given as standard of care for that type of cancer. Overall, we are working in more specific subgroups of the disease, which means automatically smaller cohorts, and the challenge is to monitor not only the treatment you add but all the other treatments given as well,” explains Charlotte Moser, Vice President, Clinical Development, Galera Therapeutics, Inc. “The longer timeline makes clinical trial design in immunotherapy especially difficult, and we still have a lot of work to do in terms of predicting response and how to best use biomarkers,” says Kinisha Gala, Project Owner of Oncology, LARVOL.

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