Tibsovo (ivosidenib) vs Onureg (azacitidine)

Tibsovo (ivosidenib) is specifically approved for the treatment of adults with acute myeloid leukemia (AML) that exhibits a particular genetic mutation called IDH1, as detected by an FDA-approved test, and is used when the disease is relapsed or refractory. On the other hand, Onureg (azacitidine) is an oral form of azacitidine approved for the continued treatment of patients with AML who are in the first remission after chemotherapy and who are not able to complete intensive curative therapy. The choice between Tibsovo and Onureg would depend on the individual's specific genetic mutation, disease stage, overall health, and treatment goals, and should be made in consultation with a healthcare professional who specializes in oncology.

Difference between Tibsovo and Onureg

Metric	Tibsovo (ivosidenib)	Onureg (azacitidine)
Generic name	Ivosidenib	Azacitidine
Indications	Acute myeloid leukemia (AML) with a specific genetic mutation (IDH1)	Newly diagnosed acute myeloid leukemia (AML) who are in remission but unable to undergo intensive chemotherapy
Mechanism of action	Inhibits mutant isocitrate dehydrogenase 1 (IDH1) enzyme	Hypomethylating agent that incorporates into RNA and DNA
Brand names	Tibsovo	Onureg
Administrative route	Oral	Oral
Side effects	Fatigue, joint pain, diarrhea, dyspnea, edema, nausea, fever, etc.	Nausea, vomiting, constipation, diarrhea, neutropenia, thrombocytopenia, etc.
Contraindications	Hypersensitivity to ivosidenib or any of its components	Hypersensitivity to azacitidine or mannitol
Drug class	Enzyme inhibitor	Antimetabolite, Hypomethylating agent
Manufacturer	Agios Pharmaceuticals, Inc.	Bristol Myers Squibb

Efficacy

Tibsovo (Ivosidenib) Efficacy in Leukemia

Tibsovo, known generically as 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 in the treatment of AML was demonstrated in a clinical trial that included patients with relapsed or refractory AML with an IDH1 mutation. The trial showed that Tibsovo induced a complete remission (CR) or complete remission with partial hematologic recovery (CRh) in a significant portion of patients. The median duration of CR plus CRh was observed to be substantial, indicating that Tibsovo can lead to durable remissions in this patient population.

Furthermore, a subset of patients treated with Tibsovo was able to proceed to stem cell transplantation, which is often considered a potential curative treatment for AML. This suggests that Tibsovo can be an effective bridge to transplant for some patients. The response rates and duration of response highlight Tibsovo's role in the management of AML with IDH1 mutations, particularly for those who have limited treatment options due to the relapsed or refractory nature of their disease.

Onureg (Azacitidine) Efficacy in Leukemia

Onureg, or azacitidine, is an oral hypomethylating agent approved by the FDA for the continued treatment of adult patients with AML who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy. The efficacy of Onureg was established in a phase III clinical trial, which demonstrated that maintenance therapy with Onureg significantly improved overall survival compared to placebo in patients with AML in remission.

The trial showed that patients receiving Onureg had a median overall survival that was markedly longer than those who received a placebo. Additionally, Onureg was associated with a delay in relapse, which is a critical aspect of AML management post-remission. These results indicate that Onureg can be an important component of AML treatment, specifically in the maintenance setting, to prolong survival and maintain quality of life for patients who are in remission but are not candidates for intensive post-remission therapies.

Regulatory Agency Approvals

Tibsovo

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

Onureg

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

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