AML-119 The Impact of Post-Remission Granulocyte Colony-Stimulating Factor (G-CSF) Use (G-CSFu) in the Phase 3 Studies of Venetoclax (Ven) Combination Treatments in Patients (Pts) With Newly Diagnosed Acute Myeloid Leukemia (AML)

Courtney DiNardo, Keith Pratz, Panayiotis Panayiotidis, Xudong Wei, Vladimir Vorobyev, Àrpád Illés, Inho Kim, Vladimir Ivanov, Grace Ku, Catherine Miller, Meng Zhang, Fernando Tatsch, Jalaja Potluri, Xenia Schmidt, Christian Recher

Research output: Contribution to journalArticlepeer-review

Abstract

Context: In VIALE-A (NCT02993523) and VIALE-C (NCT03069352), Ven+azacitidine (Aza) and low-dose cytarabine (LDAC), respectively, improved outcomes in pts with intensive chemotherapy (IC)-ineligble newly diagnosed AML. Objective: To explore outcomes in pts with G-CSFu. Design: VIALE-A/C, dosing and treatment schedule were previously described. G-CSFu was given per institutional practice. Pts who achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) were analyzed by G-CSFu. Results: In VIALE-A/C, baseline demographics were similar in Ven-treated pts regardless of G-CSFu. In VIALE-A, 190/286 pts (66%) treated with Ven+Aza and 41/145(28%) pts treated with placebo (PBO)+Aza achieved CR/CRi; 93(49%) and 10(24%) pts with CR/CRi received G-CSF (median time to first G-CSFu[range], 36d[2–483] and 35d[4–127]), respectively. Median duration of response (mDOR) for CR/CRi (95% CI) was not reached (NR; 17.5–NR) and 12.9mo(7.9–17.3) in the Ven+Aza+G-CSF and Ven+Aza+non-G-CSF groups, respectively; DOR at 12mo was 67% and 53%. Among 164 evaluable pts, measurable residual disease response (MRD<10–3) was achieved by 67, of whom 38(57%) had G-CSFu. Median overall survival (mOS[95% CI) was NR(NR–NR) with Ven+Aza+G-CSF and was 21.1mo(15.2–NR) with Ven+Aza+non-G-CSF; 12-mo OS rates were 83% and 71%. Post-remission Gr ≥3 neutropenia and febrile neutropenia (FN) rates were 33%(n=31) and 39%(n=36) with Ven+Aza+G-CSF, and 29%(n=28) and 20%(n=19) with Ven+Aza+non-G-CSF, respectively. Median durations of post-remission Gr ≥3 neutropenia and FN were 12.5d and 8d (Ven+Aza+G-CSF), and 16d and 10.5d (Ven+Aza+non-G-CSF). In VIALE-C, 69/143 pts (48%) treated with Ven+LDAC and 9/68(13%) pts treated with PBO+LDAC achieved CR/CRi; 30(43%) and 2(22%) received G-CSF (median time to first G-CSFu[range], 30d[2–459] and 229d[169–289]), respectively. mDOR was 10.8(4.9–17.8) and 11.8mo(5.9–NR) in the Ven+LDAC+G-CSF and Ven+LDAC+non-G-CSF groups, respectively; DOR at 12mo was 45% and 49%. mOS was 20.8mo(11.9–NR) with Ven+LDAC+G-CSF and 13.7mo(10.8–NR) with Ven+LDAC+non-G-CSF; 12-mo OS were ~68% and ~57%; 9/64 evaluable pts achieved MRD<10–3, of whom 6(67%) had G-CSFu. Post-remission Gr ≥3 neutropenia and FN rates were 53%(n=16) and 23%(n=7) with Ven+LDAC+G-CSF, and 51%(n=20) and 8%(n=3) with Ven+LDAC+non-G-CSF, respectively. Median durations of post-remission Gr≥3 neutropenia and FN were 15d and 6d(Ven+LDAC+G-CSF), and 12.5d and 29d(Ven+LDAC+non-G-CSF). Conclusions: Gr ≥3 neutropenia and FN with G-CSFu trended towards shorter duration, without negative impact on DOR or OS.

Original languageEnglish
Pages (from-to)S214
JournalClinical Lymphoma, Myeloma and Leukemia
Volume22
DOIs
StatePublished - Oct 2022
Externally publishedYes

Keywords

  • AML
  • BCL2
  • G-CSF
  • Phase III
  • acute myeloid leukemia
  • neutropenia

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