Phase 2 Trial of Parsaclisib Shows Efficacy in Marginal Zone Lymphoma

Tycel J. Phillips, MD, assistant professor at the University of Michigan Cancer Center, discusses the design and responses at 8 weeks in a phase 2 trial of parsaclisib in patients with relapsed/refractory marginal zone lymphoma (MZL).

The CITADEL-204 trial has responses from the first 8 weeks, the AEs that occurred in result of the transition to maintenance therapy. Maintenance therapy was administered at 2.5 mg daily versus 20 mg weekly in this study. This dosing was chosen based on some of the other studies that evaluated this agent, according to Phillips. There was a difference in the maintenance dosing due to the response on the trial.

Phillips says that ultimately, the responses were great, the agent was well tolerated, and some of the information that the investigators believed was true, such as the 8-week response, came to fruition. These observations were the key takeaways from this research.

As more data are gathered, the next data that will be looked at are the mature responses, responses that are observed in different MZL subtypes, and the long-term toxicity data. Notably, the adverse events associated with PI3K inhibitors, in general, are one of the greatest roadblocks, according to Phillips. When comparing the data of parsaclisib with other approved agents in this setting, there were some similarities. Due to this, the investigators are hopeful that more agents will be approved in the future.