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Parsaclisib in Japanese patients with relapsed or refractory B-cell lymphoma (CITADEL-111): A phase Ib study.
Fukuhara, Noriko; Suehiro, Youko; Kato, Harumi; Kusumoto, Shigeru; Coronado, Cinthya; Rappold, Erica; Zhao, Wanying; Li, Jia; Gilmartin, Aidan; Izutsu, Koji.
Afiliação
  • Fukuhara N; Department of Hematology, Tohoku University Hospital, Sendai, Japan.
  • Suehiro Y; Department of Hematology, National Hospital Organization, Kyushu Cancer Center, Fukuoka, Japan.
  • Kato H; Department of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan.
  • Kusumoto S; Department of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
  • Coronado C; Incyte Corporation, Wilmington, Delaware, USA.
  • Rappold E; Incyte Corporation, Wilmington, Delaware, USA.
  • Zhao W; Incyte Corporation, Wilmington, Delaware, USA.
  • Li J; Incyte Corporation, Wilmington, Delaware, USA.
  • Gilmartin A; Incyte Corporation, Wilmington, Delaware, USA.
  • Izutsu K; Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.
Cancer Sci ; 113(5): 1702-1711, 2022 May.
Article em En | MEDLINE | ID: mdl-35201656
ABSTRACT
Parsaclisib, a potent, selective, next-generation PI3Kδ inhibitor, has shown clinical benefit in patients with relapsed or refractory B-cell lymphoma. We undertook a phase Ib study (CITADEL-111) evaluating safety, pharmacokinetics, and efficacy of parsaclisib in Japanese patients with relapsed or refractory B-cell malignancies. Patients received oral parsaclisib daily for 8 weeks then once weekly (10-mg dose, n = 3; 20-mg dose, n = 14). Pharmacokinetic samples were collected on days 1, 8, and 15, and efficacy was monitored according to Lugano criteria. At data cut-off (August 14, 2020), 6 patients (35.3%) remained on study treatment and 11 (64.7%) discontinued due to progressive disease (9 [52.9%]) or adverse events (2 [11.8%]). Median duration of treatment was 8.3 (range, 0.3-24.4) months. The most commonly reported nonhematologic adverse events were constipation (6 [35.3%]), nausea, and pyrexia (each 4 [23.5%]). Five patients (29.4%) experienced treatment-emergent new or worsening decreased neutrophils to grade 3 or 4. No treatment-emergent worsening in aminotransferase elevations to grade 3 or 4 were observed. Ten patients (58.8%) required dose interruption and 5 (29.4%) dose reduction. Body weight-normalized parsaclisib exposure was comparable between Japanese and Western patients. Objective response rate was 100% in follicular lymphoma (9 of 9 patients, including complete response in 2 patients [22.2%]) and marginal zone lymphoma (2 of 2 patients), and 16.7% in diffuse large B-cell lymphoma (1 of 6 patients). Results observed in Japanese patients with relapsed or refractory follicular or marginal zone lymphoma support further clinical development of parsaclisib in these patient populations.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Linfoma Folicular / Linfoma Difuso de Grandes Células B Limite: Humans País como assunto: Asia Idioma: En Ano de publicação: 2022 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Linfoma Folicular / Linfoma Difuso de Grandes Células B Limite: Humans País como assunto: Asia Idioma: En Ano de publicação: 2022 Tipo de documento: Article