Developing Immuno-Oncology Treatments: Challenges in Clinical Trial Design

Both the sheer number of new treatments and the rapidly changing landscape in immuno-oncology create challenges for pharmaceutical and biotech developers during clinical trials. I recently examined a few of these key issues in a PharmaVOICE article looking at next-generation immuno-oncology treatments.

The promise of checkpoint inhibitors

Checkpoint inhibitors, a class of immuno-oncology drugs that ‘removes the brakes’ and reengages a patient’s own T-cells to recognize and wipe out cancer cells, hold a great deal of promise for the future of immuno-oncology. Their success to date has caused “a 25-fold increase” in the pipeline from 2010 to 2015, according to the PharmaVOICE article. As more developers jump into this space, the standard of care is evolving – and quickly, even within the time period of a clinical trial. The constantly shifting landscape can make designing a protocol for a specific indication increasingly complex. Further, checkpoint inhibitors have broad potential, and they can in theory be used to augment almost any kind of therapy, thereby introducing more complexity as to best determine how they should be tested and used.

Flexibility is the key

There has been an explosion in the number of possible clinical trial designs for checkpoint inhibitors, and they are increasingly being conducted with multiple arms. Basket and mono/combo designs are especially becoming more common for their ability to test multiple indications and combinations in a single trial.

To best navigate this complex environment, I suggest that biopharma companies should remain flexible by creating open-ended options in their protocols and allow for protocol amendments. The CEO of Argo Therapeutics also points out in the article that sponsors need to take a rational approach to protocol design, one that thoughtfully considers the mechanism of action of different checkpoints, and then must perform the necessary preclinical work to test their theories.

To learn more about best practices in designing clinical trials for immuno-oncology treatments, read our white paper “Mastering Oncology Immunotherapy Clinical Trials.”

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