Phase 1b study to investigate the safety and tolerability of idelalisib in Japanese patients with relapsed/refractory follicular lymphoma and chronic lymphocytic leukemia

Noriko Fukuhara, Tomohiro Kinoshita, Kazuhito Yamamoto, Hirokazu Nagai, Koji Izutsu, Go Yamamoto, Pankaj Bhargava, Nishan Rajakumaraswamy, Rita Humeniuk, Anita Mathias, Guan Xing, Masato Fukui, Kensei Tobinai

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

Objective: Idelalisib is an orally administered, highly selective inhibitor of phosphatidylinositol 3-kinase-δ. In this phase 1b study, the safety, tolerability and pharmacokinetics of idelalisib, an oral inhibitor of phosphatidylinositol 3-kinase-δ, were evaluated in Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma. Methods: In total, six patients (follicular lymphoma: n = 3, chronic lymphocytic leukemia: n = 3) were enrolled to receive idelalisib 150 mg twice daily. Results: No dose-limiting toxicities were reported. The most common adverse events were diarrhea (n = 5), gastritis (n = 3), insomnia (n = 3) and pyrexia (n = 3). The most common ≥grade 3 adverse events were diarrhea (n = 2), increased transaminase levels (n = 2) and decreased appetite (n = 2). The maximum idelalisib plasma concentrations (Cmax) were achieved at 2.50 h (range: 1.50-4.00 h). The mean idelalisib plasma concentrations decreased over time but remained detectable in most patients at 12 h. All enrolled patients underwent efficacy evaluation by investigators, and five patients (follicular lymphoma: n = 2, chronic lymphocytic leukemia: n = 3) achieved partial response. The median duration of partial response was 14.5 months (range: 3.7-31.3 months). Conclusion: Idelalisib 150 mg twice daily was considered tolerable in Japanese patients with follicular lymphoma or chronic lymphocytic leukemia. (Clinical trial registration: NCT02242045)

Original languageEnglish
Pages (from-to)1395-1402
Number of pages8
JournalJapanese journal of clinical oncology
Volume50
Issue number12
DOIs
Publication statusPublished - 2020 Dec 1

Keywords

  • chronic lymphocytic leukemia
  • follicular lymphoma
  • idelalisib
  • phase 1 study
  • safety

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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