Phase I study of duvelisib in Japanese patients with relapsed or refractory lymphoma.

Abstract

Duvelisib is a novel dual inhibitor of phosphoinositide-3-kinase (PI3K)-δ and -γ. This single-arm, multicenter phase I study investigated its safety, pharmacokinetics, and preliminary efficacy in Japanese patients with relapsed or refractory lymphoma. Duvelisib was administered orally twice daily at 25 mg in 28-day cycles. Seven patients, comprising 4 with follicular lymphoma (FL), 2 with diffuse large B-cell lymphoma, and 1 with mantle cell lymphoma (MCL) were enrolled. No dose-limiting toxicity occurred in any patient. The most commonly experienced treatment-related adverse events of any grade were neutropenia and thrombocytopenia, occurring in 3 patients each (42.9%); followed by lymphopenia, diarrhea, enterocolitis, stomatitis, hepatic function abnormal, ALT increased, and AST increased, occurring in 2 patients each (28.6%). The most common grade ≥ 3 treatment-related adverse events were neutropenia, which occurred in 3 patients (42.9%), and thrombocytopenia, lymphopenia, and hepatic function abnormal, which occurred in 2 patients each (28.6%). One patient with FL achieved a complete response; the remaining 3 with FL and the 1 with MCL achieved a partial response. The overall response rate was 71.4% (5/7 patients). Duvelisib was well tolerated in Japanese patients with relapsed or refractory lymphoma. Safety and preliminary efficacy data support further development of duvelisib in Japanese patients.

• Authors: Koji Izutsu, Koji Kato, Hitoshi Kiyoi, Go Yamamoto, Kazuyuki Shimada, Koichi Akashi
• Journal: International journal of hematology (Int J Hematol) Vol. 112 Issue 4 Pg. 504-509 (Oct 2020) ISSN: 1865-3774 [Electronic] Japan
• PMID: 32613313 (Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study)

Chemical References

• Isoquinolines
• Phosphoinositide-3 Kinase Inhibitors
• Purines
• duvelisib

Topics

• Asian People
• Drug Administration Schedule
• Female
• Humans
• Isoquinolines (administration & dosage, adverse effects)
• Lymphoma, Follicular (drug therapy)
• Lymphoma, Large B-Cell, Diffuse (drug therapy)
• Lymphoma, Mantle-Cell (drug therapy)
• Male
• Neutropenia (etiology)
• Phosphoinositide-3 Kinase Inhibitors (administration & dosage, adverse effects)
• Purines (administration & dosage, adverse effects)
• Thrombocytopenia (etiology)
• Treatment Outcome