The AGILE study: Safety profile of TIBSOVO® + azacitidine
TIBSOVO® + azacitidine had a well characterized safety profile
Adverse reactions in ≥5% newly diagnosed AML patients treated with TIBSOVO® in combination with azacitidine in AGILE (N=72)1,2
System Organ Class Preferred Term | TIBSOVO® + azacitidine (N=72) | |
|---|---|---|
Gastrointestinal disorders | ||
Vomiting | 16 (22) | |
Blood and lymphatic system disorders | ||
Neutropenia | 14 (19) | |
Thrombocytopenia | 10 (14) | |
Differentiation syndrome | 10 (14) | |
Leukocytosis | 7 (10) | |
Leukopenia | 4 (6) | |
Investigations | ||
Electrocardiogram QT prolonged | 14 (19) | |
Nervous system disorders | ||
Headache | 4 (6) | |
Psychiatric Disorder | ||
Insomnia | 4 (6) | |
1Data cut-off date 30 Jun 2022
2Adverse drug reactions related to TIBSOVO®/placebo are included, regardless of relatedness with azacitidine. Relatedness was assessed by investigators.
Adapted from the TIBSOVO® Product Monograph.
Select hematological laboratory abnormalities1,2 (≥10%) that worsened from baseline in patients with AML who received TIBSOVO® + azacitidine in AGILE
Parameter | TIBSOVO® + azacitidine
|
|---|---|
Leukocytes decreased | 46 (64) |
Platelets decreased | 43 (60) |
Hemoglobin decreased | 41 (57) |
Neutrophils decreased | 19 (26) |
Lymphocytes increased | 18 (25) |
Lymphocytes decreased | 41 (57) |
1 Laboratory abnormality is defined as new or worsened by at least one grade from baseline, or if baseline is unknown.
2 The denominator used to calculate percentages is the number of treated subjects who can be evaluated for CTCAE criteria for each parameter in each arm.
Adapted from the TIBSOVO® Product Monograph.
Consult the TIBSOVO® Product Monograph
2-HG: 2-hydroxyglutarate; α-KG: alpha-ketoglutarate; AML: acute myeloid leukemia; AZA: azacitidine; PBO: placebo; CCA: cholangiocarcinoma; CI: confidence interval; CR: complete response; CRh: complete response with partial hematologic recovery; CTCAE: Common Terminology Criteria for Adverse Events; DLCO: diffusing capacity for carbon monoxide; ECG: electrocardiogram; ECOG PS: Eastern Cooperative Oncology Group Performance Status; EFS: event-free survival; eGFR: estimated glomerular filtration rate; FEV1: forced expiratory volume in 1 second; HR: hazard ratio; IDH1: isocitrate dehydrogenase-1; IRC: Independent Radiology Centre; IV: intravenous; mIDH1: mutated isocitrate dehydrogenase-1; MOA: mechanism of action; NCCN: National Comprehensive Cancer Network; OR: odds ratio; OS: overall survival; PBO: placebo; PCR: polymerase chain reaction; PD: pharmacodynamics; PK: pharmacokinetics; QD: daily; RECIST: Response Evaluation Criteria In Solid Tumors; SC: subcutaneous.
References:
- TIBSOVO® Product Monograph. Servier Canada. July 19, 2024.
- Montesinos P, et al. N Engl J Med. 2022 Apr 21;386(16):1519–1531.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Acute Myeloid Leukemia Version 2.2025 — January 27, 2025.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Biliary Duct Cancers Version 6.2024 — January 10, 2025.
- Abou-Alfa GK, et al. Lancet Oncol. 2020 Jun;21(6):796-807.
- Zhu AX, et al. JAMA Oncol. 2021 Nov 1;7(11):1669-1677.
- Dammacco F, Silvestris F, eds. Oncogenomics: From Basic Research to Precision Medicine. Academic Press; 2019.
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