Venetoclax in combination with azacitidine in Japanese patients with acute myeloid leukaemia: phase 1 trial findings

Shuichi Taniguchi, Takahiro Yamauchi, Ilseung Choi, Noriko Fukuhara, Jalaja Potluri, Ahmed Hamed Salem, Wan Jen Hong, Hideyuki Honda, Yasuko Nishimura, Sumiko Okubo, Kensuke Usuki

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND: Venetoclax plus azacitidine is indicated in the USA for the treatment of newly diagnosed acute myeloid leukaemia in older patients (≥75 years) or those ineligible for induction chemotherapy due to co-morbidities. METHODS: In this phase 1/2 study (NCT02265731), Japanese patients (≥60 years) with untreated (ineligible for induction chemotherapy) or relapsed/refractory acute myeloid leukaemia received oral venetoclax 400 mg/day (3-day ramp up in cycle 1) plus subcutaneous or intravenous azacitidine 75 mg/m2 on days 1-7 per 28-day cycle until disease progression or unacceptable toxicity. RESULTS: As of 10 December 2019, six patients were enrolled (median age: 75 years; untreated: n = 5; relapsed/refractory: n = 1); median treatment duration: 10.3 months (range, 0.7-29.4). Most common grade ≥ 3 adverse events were lymphopaenia and febrile neutropaenia (n = 4 each). Four patients reported serious adverse events; only an event of grade 3 fungal pneumonia was considered possibly related to both study drugs, requiring dose interruption of venetoclax and delay of azacitidine. Five (83%) patients had responses (complete remission: n = 3). Median time to first response of complete remission/complete remission with incomplete count recovery was 1.0 month (range, 0.8-5.5); median overall survival: 15.7 months (95% confidence interval: 6.2, not reached). CONCLUSIONS: Venetoclax plus azacitidine was well tolerated and showed high response rates in Japanese patients with acute myeloid leukaemia.

Original languageEnglish
Pages (from-to)857-864
Number of pages8
JournalJapanese journal of clinical oncology
Volume51
Issue number6
DOIs
Publication statusPublished - 2021 May 28

Keywords

  • AML
  • BCL-2
  • Japan
  • anti-neoplastic agents
  • apoptosis

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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