The CLARIDHY study: Safety profile of TIBSOVO®
TIBSOVO® had a well characterized safety profile
Adverse reactions in ≥5% of patients with locally advanced or metastatic CCA treated with TIBSOVO® in the CLARIDHY trial (N=123)1
System Organ Class Preferred Term | TIBSOVO® (N=123) | |
|---|---|---|
Blood and lymphatic system disorders | ||
Anemia | 6 (5) | |
Gastrointestinal disorders | ||
Nausea | 28 (23) | |
Diarrhea | 28 (23) | |
Abdominal pain* | 12 (10) | |
Vomiting† | 12 (10) | |
General disorders and administration site conditions | ||
Fatigue‡ | 24 (20) | |
Metabolism and nutrition disorders | ||
Decreased appetite | 11 (9) | |
Investigations | ||
Aspartate aminotransferase increased | 6 (5) | |
Electrocardiogram QT prolonged | 8 (7) | |
Nervous system disorders | ||
Headache | 10 (8) | |
Skin and subcutaneous tissue disorders | ||
Rash§ | 7 (6) | |
Final database lock date June 21, 2021. Adverse drug reactions related to TIBSOVO®/placebo are included. Relatedness was assessed by investigators.
* Grouped term includes abdominal pain, abdominal pain upper, abdominal discomfort, abdominal pain
lower, epigastric discomfort and abdominal tenderness (and gastrointestinal pain in the placebo group
only).
† Grouped term includes vomiting and retching.
‡ Grouped term includes asthenia and fatigue.
§ Grouped term includes rash, rash maculo-papular, erythema, rash macular, dermatitis exfoliative
generalized, drug eruption, and drug hypersensitivity.
Adapted from the TIBSOVO® Product Monograph.
Selected laboratory abnormalities occurring in ≥10% of patients receiving TIBSOVO® for hematology or chemistry parameters in the CLARIDHY trial
TIBSOVO®
| ||||
|---|---|---|---|---|
Hematology parameters | ||||
Hemoglobin decreased | 48 (40) | |||
Chemistry parameters | ||||
AST increased | 41 (34) | |||
Bilirubin increased | 36 (30) | |||
Laboratory abnormality is defined as new or worsened by at least one grade from baseline, or baseline is unknown.
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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