Amitkumar Mehta, MD, discusses the toxicity profile of parsaclisib in the phase 2 CITADEL-205 clinical trial of relapsed/refractory mantle cell lymphoma.
Amitkumar Mehta, MD, an associate professor at the University of Alabama at Birmingham Comprehensive Cancer Center, discusses the toxicity profile of the first-in-class PI3Kδ inhibitor parsaclisib, according to findings from this agent in the phase 2 CITADEL-205 clinical trial (NCT03235544) of relapsed/refractory mantle cell lymphoma (MCL).
Parsaclisib is a highly specific PI3Kδ inhibitor compared with the other PI3Kδ inhibitors, and it was designed to reduce transaminitis as a side effect, says Mehta. This study aimed to explore the efficacy and safety of this therapy.
Overall, the occurrence of transaminitis was very low, especially in terms of grade 3/4 toxicity, which occurred in about 3% to 4%. Diarrhea was observed, which is a known class side effect, according to Mehta. Grade 3 or higher diarrhea occurred in about 13% of patients in the study, and for about half of the patients, this was reason for discontinuation.
Mehta says physicians have learned to be proactive about this side effect. If a patient has diarrhea, physicians should act quickly to manage it.