Tibsovo (ivosidenib) vs Inqovi (decitabine and cedazuridine)

Tibsovo (ivosidenib) is specifically approved for the treatment of adults with acute myeloid leukemia (AML) that exhibits a particular genetic mutation known as IDH1, and its use is contingent upon the confirmation of this mutation by an FDA-approved test. In contrast, Inqovi (decitabine and cedazuridine) is a combination therapy used for the treatment of adults with myelodysplastic syndromes (MDS), including certain types of chronic myelomonocytic leukemia (CMML), and does not target a specific genetic mutation. When deciding between these medications, it is crucial for a patient to discuss with their healthcare provider the specific type and characteristics of their disease, including genetic mutations, to determine the most appropriate treatment option.

Difference between Tibsovo and Inqovi

Metric	Tibsovo (ivosidenib)	Inqovi (decitabine and cedazuridine)
Generic name	Ivosidenib	Decitabine and Cedazuridine
Indications	Acute myeloid leukemia (AML) with a specific genetic mutation (IDH1)	Myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with various French-American-British (FAB) classifications, and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups
Mechanism of action	Inhibits the mutant IDH1 enzyme, leading to a reduction in the oncometabolite 2-hydroxyglutarate (2-HG) levels	Decitabine: Hypomethylating agent that incorporates into DNA and inhibits DNA methyltransferase. Cedazuridine: Cytidine deaminase inhibitor that increases the bioavailability of decitabine
Brand names	Tibsovo	Inqovi
Administrative route	Oral	Oral
Side effects	Fatigue, leukocytosis, arthralgia, diarrhea, dyspnea, edema, nausea, mucositis, QT prolongation, rash, fever, cough, constipation	Thrombocytopenia, neutropenia, anemia, febrile neutropenia, fatigue, hemorrhage, myalgia, mucositis, constipation, rash, dizziness, and dyspnea
Contraindications	Hypersensitivity to ivosidenib or any of the excipients	Hypersensitivity to decitabine or cedazuridine, or any component of the formulation
Drug class	Isocitrate dehydrogenase-1 (IDH1) inhibitor	Hypomethylating agent (decitabine); Cytidine deaminase inhibitor (cedazuridine)
Manufacturer	Agios Pharmaceuticals, Inc.	Astex Pharmaceuticals, Inc.

Efficacy

Efficacy of Tibsovo (Ivosidenib) in Treating Leukemia

Tibsovo, also known as ivosidenib, is a medication specifically indicated for the treatment of acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. The efficacy of Tibsovo in treating AML was demonstrated in a clinical trial that included patients with relapsed or refractory AML with an IDH1 mutation. In this study, Tibsovo showed a significant rate of complete remission (CR) or complete remission with partial hematologic recovery (CRh), which are important clinical endpoints indicating the absence of leukemia cells in the body. The rate of CR plus CRh was observed in a notable proportion of patients, and the duration of these responses was clinically meaningful.

The trial also highlighted the median time to first response and the median duration of response for patients treated with Tibsovo. The responses were observed within a few months of treatment initiation, and many patients maintained their responses for an extended period. The data underlined the potential of Tibsovo as an effective treatment option for patients with AML that harbor the specific IDH1 mutation, offering a targeted therapeutic approach in a subset of this challenging hematologic malignancy.

Efficacy of Inqovi (Decitabine and Cedazuridine) in Treating Leukemia

Inqovi, which combines decitabine and cedazuridine, is approved for the treatment of adults with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with various French-American-British (FAB) classifications, and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups. This combination therapy is also indicated for chronic myelomonocytic leukemia (CMML). The efficacy of Inqovi was established through clinical trials that assessed its impact on hematologic parameters and the need for transfusions.

Clinical trials demonstrated that Inqovi was effective in achieving complete remission or marrow complete remission in a significant number of patients, with some patients also showing hematologic improvement. The drug combination provided the convenience of oral administration, which is an important aspect of treatment adherence and patient quality of life. The duration of these responses, as well as the reduction in transfusion dependence, was significant, indicating that Inqovi is a valuable treatment option for patients with MDS and CMML.

Regulatory Agency Approvals

Tibsovo

European Medical Agency (EMA), European Union
Food and Drug Administration (FDA), USA

Inqovi

Food and Drug Administration (FDA), USA
Health Canada

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