Inqovi (decitabine and cedazuridine) vs Elzonris (tagraxofusp-erzs)

Inqovi (decitabine and cedazuridine) is an oral hypomethylating agent approved for the treatment of adults with myelodysplastic syndromes (MDS), including certain types of chronic myelomonocytic leukemia (CMML). Elzonris (tagraxofusp-erzs) is a targeted therapy known as a CD123-directed cytotoxin indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients aged 2 years and older. When deciding between these medications, it is crucial to consider the specific type of blood or bone marrow condition being treated, as Inqovi is tailored for MDS and CMML, while Elzonris is specifically for BPDCN, and the choice must be based on the diagnosis, overall health, and treatment goals discussed with a healthcare provider.

Difference between Inqovi and Elzonris

Metric	Inqovi (decitabine and cedazuridine)	Elzonris (tagraxofusp-erzs)
Generic name	Decitabine and cedazuridine	Tagraxofusp-erzs
Indications	Myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.	Treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients aged 2 years and older.
Mechanism of action	Decitabine is a nucleoside metabolic inhibitor that inhibits DNA methyltransferase, leading to hypomethylation of DNA and cellular differentiation or apoptosis. Cedazuridine is a cytidine deaminase inhibitor that increases the exposure of decitabine.	Tagraxofusp-erzs is a CD123-directed cytotoxin and is the first targeted therapy to inhibit CD123, a cell surface receptor expressed on a range of malignancies, including BPDCN cells.
Brand names	Inqovi	Elzonris
Administrative route	Oral	Intravenous
Side effects	Fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia, and transaminase increased.	Capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, weight increase, chills, and tachycardia.
Contraindications	Hypersensitivity to decitabine, cedazuridine or any component of the formulation.	Hypersensitivity to tagraxofusp-erzs or any component of the formulation; concurrent use of systemic corticosteroids at doses greater than physiologic dosing.
Drug class	Hypomethylating agent, DNA methyltransferase inhibitor	CD123-directed cytotoxin
Manufacturer	Astellas Pharma US, Inc.	Stemline Therapeutics, Inc.

Efficacy

Inqovi (decitabine and cedazuridine) Efficacy in Leukemia

Inqovi, a combination of decitabine and cedazuridine, is an oral hypomethylating agent approved for the treatment of adults with myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML). MDS is considered a type of cancer that can progress to acute myeloid leukemia (AML). Clinical trials have demonstrated the efficacy of Inqovi in treating these conditions. In a pivotal study, Inqovi showed a complete response (CR) rate in line with that of intravenous decitabine, offering an effective oral alternative for patients who may not tolerate or prefer not to have intravenous treatment.

The efficacy of Inqovi for patients with MDS and CMML was evaluated in two open-label, randomized, crossover trials, where patients received either Inqovi or intravenous decitabine. The results indicated that Inqovi was effective in achieving a CR and had a similar safety profile to intravenous decitabine. This oral formulation allows for the convenience of at-home administration, potentially improving the quality of life for patients who require ongoing treatment for their leukemia-related conditions.

Elzonris (tagraxofusp-erzs) Efficacy in Leukemia

Elzonris (tagraxofusp-erzs) is a targeted therapy approved for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare form of leukemia. The efficacy of Elzonris was established in a multicenter, single-arm clinical trial that included patients with untreated and relapsed or refractory BPDCN. The trial demonstrated a significant response rate in patients, with a majority achieving a clinical response, which included complete responses and clinical complete responses with minimal residual disease.

For patients with BPDCN, Elzonris has shown a promising efficacy profile, with the trial results indicating that a considerable number of patients achieved either a complete response or a clinical complete response. The treatment has been a significant advancement in the management of BPDCN, as it is the first therapy specifically indicated for this type of leukemia. The availability of Elzonris provides a much-needed treatment option for patients with BPDCN, who previously had limited targeted therapies available.

Regulatory Agency Approvals

Inqovi

Food and Drug Administration (FDA), USA
Health Canada

Elzonris

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

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