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ASH 2021 | CITADEL-204: parsaclisib in R/R MZL

Tycel Phillips, MD, University of Michigan, Ann Arbor, MI, shares results of the primary analysis of the cohort of Bruton’s tyrosine kinase (BTK) inhibitor-naive patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) treated with parsaclisib in the Phase II CITADEL-204 study (NCT03144674). In total, 100 patients were enrolled and allocated to receive parsaclisib 20 mg once daily for eight weeks, followed by either 20 mg once weekly or 2.5 mg once daily. The study demonstrated a rapid and durable response to parsaclisib in multiple subtypes of MZL. Additionally, the PI3Kδ inhibitor was generally well tolerated with a manageable safety profile. Overall, these results suggest that parsaclisib may be a potential treatment for R/R MZL, where few agents are approved. This interview took place at the 63rd ASH Annual Meeting and Exposition congress in Atlanta, GA.

Transcript (edited for clarity)

CITADEL-204 was a Phase II study evaluating the PI3 kinase δ inhibitor parsaclisib in patients with relapsed/refractory marginal zone lymphoma. The study was originally designed to evaluate two cohorts, BTK inhibitor-experienced and the BTK inhibitor-naive patients with marginal zone lymphoma. Due to enrollment feasibility issues, we did close the BTK inhibitor-experienced cohort and focused on those who were BTK inhibitor-naive...

CITADEL-204 was a Phase II study evaluating the PI3 kinase δ inhibitor parsaclisib in patients with relapsed/refractory marginal zone lymphoma. The study was originally designed to evaluate two cohorts, BTK inhibitor-experienced and the BTK inhibitor-naive patients with marginal zone lymphoma. Due to enrollment feasibility issues, we did close the BTK inhibitor-experienced cohort and focused on those who were BTK inhibitor-naive. In total, we enrolled 100 patients. They were started with parsaclisib, 20 milligrams once daily. Then patients were then allocated one-to-one into a 2.5 milligrams daily dosing or 20 milligrams once-weekly dosing. The vast majority, 72 of the 100, were eventually treated at the 2.5 milligrams once-daily dosing for maintenance and that was the dose put forth to move forward in Phase 2 dosing.

From this study, what we demonstrated is that parsaclisib was effective in multiple different subtypes of marginal zone lymphoma: nodal, splenic marginal zone lymphoma, and extranodal. We didn’t notice any specific efficacy differences between the three different arms. Toxicity, which has been a concern obviously with PI3 kinase δ inhibitors, and that’s part of the reason why we explored the maintenance dosing. We did see continued reports of diarrhea, colitis, and infection. But compared to what we see with daily dosing, frequencies are much reduced with the use of the maintenance dosing.

Moving forward, obviously, with marginal zone lymphoma, there are a few approved agents: BTK inhibitors, R². But parsaclisib does fit in quite appropriately with the available PI3 kinase δ inhibitors that are currently available. That gives another oral option for these patients pending further maturation of the data and how the company puts forth the medication.

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