Beware the Octo-trial
Immunotherapy has played an integral role in oncology research for more than a century, but in the last few years we’ve seen extraordinary discoveries that are transforming the way we think about cancer treatment. New advances in immunotherapies including cancer vaccines, CAR T-Cell Therapies, PD-1/PD-L1 inhibitors, and other therapies and diagnostics are transforming the standard of care and significantly improving survival rates for these patients.
This transformation is exciting for industry, but it is adding a lot of complexity to the drug development process that sponsors, CROs and investigative sites need to address. Delivering targeted immunotherapies to market requires more sophisticated site selection, and monitoring and oversight processes particularly in early phase trials in which changing standards of care and multiple arms can easily overwhelm site staff adding time, cost and risk to the trial process.
But it doesn’t have to be overwhelming. When sponsors and CROs address the following five challenges they can mitigate many of the risks that come with these trials and increase the ease with which they bring these treatments to market.
Challenge #1: The rapidly changing standard of care
Immuno-oncology research is a constantly changing science, and every new discovery has the potential to impact related ongoing trials. For example, FDA’s approval of nivolumab and pembrolizumab, which are both PD-1 inhibitors, changed the standard of care for non-small cell lung cancer (NSCLC). If a sponsor was running a third-line study after those drugs were approved, the trial might suddenly become difficult to recruit.
To increase site’s adaptability, studies should be designed for flexibility to better enable changes midstream. This includes having pre-defined processes in place to quickly amend protocols, communicate changes to site teams, and reallocate human and capital resources as necessary. It also requires a robust education program for site monitors and investigators to keep them fully up to date on changing safety signals, including evolving toxicity management guidelines, and the importance of tracking immuno-related events as evidence of progression.