Tibsovo (ivosidenib) vs Asparlas (calaspargase pegol-mknl)

Tibsovo (ivosidenib) and Asparlas (calaspargase pegol-mknl) are used to treat different types of cancer and have distinct mechanisms of action. Tibsovo is approved for the treatment of acute myeloid leukemia (AML) with a specific genetic mutation (IDH1), and it works by inhibiting the mutant IDH1 enzyme, thereby reducing the abnormal cell growth. In contrast, Asparlas is a modified enzyme used as part of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL), and it works by depleting the amino acid asparagine, which leukemia cells need to survive and proliferate. The choice between these medications would depend on the specific type of leukemia diagnosed and the presence of particular genetic mutations, as determined by a healthcare provider.

Difference between Tibsovo and Asparlas

Metric	Tibsovo (ivosidenib)	Asparlas (calaspargase pegol-mknl)
Generic name	Ivosidenib	Calaspargase pegol-mknl
Indications	Acute myeloid leukemia (AML) with a specific genetic mutation (IDH1)	Acute lymphoblastic leukemia (ALL) as part of a multi-agent chemotherapeutic regimen
Mechanism of action	Inhibits mutant IDH1 enzyme, leading to decreased production of the oncometabolite 2-hydroxyglutarate (2-HG)	Hydrolyzes L-asparagine, which deprives leukemia cells of an essential amino acid for protein synthesis and tumor growth
Brand names	Tibsovo	Asparlas
Administrative route	Oral	Intravenous
Side effects	Fatigue, leukocytosis, arthralgia, diarrhea, dyspnea, edema, nausea, mucositis, QT interval prolongation, rash, etc.	Allergic reactions, elevated liver enzymes, decreased albumin blood levels, pancreatitis, abnormal clotting, nausea, etc.
Contraindications	Hypersensitivity to ivosidenib or any of its components	Hypersensitivity to calaspargase pegol-mknl, pegaspargase, or any of its components; history of serious thrombosis with prior L-asparaginase therapy; history of serious hemorrhagic events with prior L-asparaginase therapy; severe hepatic impairment
Drug class	Isocitrate dehydrogenase-1 (IDH1) inhibitor	Modified amino acid (asparagine) specific enzyme
Manufacturer	Agios Pharmaceuticals, Inc.	Servier Pharmaceuticals LLC

Efficacy

Efficacy of Tibsovo (Ivosidenib) in Treating Leukemia

Tibsovo (ivosidenib) is an oral medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML) with a specific genetic mutation known as isocitrate dehydrogenase-1 (IDH1). The efficacy of Tibsovo was demonstrated in a clinical trial that included patients with relapsed or refractory AML with an IDH1 mutation. In this study, Tibsovo showed a complete remission (CR) rate, which means the disappearance of all signs of cancer in response to treatment, in a significant percentage of patients. Additionally, some patients achieved complete remission with partial hematologic recovery (CRh), indicating a reduction in the severity of the disease and some recovery of blood cell counts.

The duration of response to Tibsovo varied among patients, with some experiencing sustained remissions. The median duration of CR plus CRh was reported to be substantial, indicating that the drug can provide a durable response for a period of time in patients with IDH1-mutated AML. The response rates and duration of response are important indicators of the drug's efficacy in treating this specific form of leukemia.

Efficacy of Asparlas (Calaspargase Pegol-mknl) in Treating Leukemia

Asparlas (calaspargase pegol-mknl) is an asparagine-specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL). The drug is a modified form of L-asparaginase, which works by depleting the amino acid asparagine, a nutrient that leukemia cells require to survive. Asparlas has been shown to maintain asparagine depletion for a longer duration compared to native forms of L-asparaginase, which is beneficial for reducing the frequency of dosing and potentially improving patient compliance.

The efficacy of Asparlas was evaluated in clinical trials where it was used as part of a treatment regimen for patients with ALL. The trials demonstrated that Asparlas was effective in achieving and maintaining therapeutic levels of asparagine depletion. Moreover, the drug was associated with a complete remission rate in line with historical control rates for ALL when used in combination with other chemotherapeutic agents. The overall survival and disease-free survival rates observed in patients treated with Asparlas-containing regimens further support its efficacy in the treatment of ALL.

Regulatory Agency Approvals

Tibsovo

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

Asparlas

Food and Drug Administration (FDA), USA

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