Efficacy

Efficacy of Inqovi for Leukemia

Inqovi (decitabine and cedazuridine) is a combination of two chemotherapeutic agents used in the treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British (FAB) subtypes: refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia (CMML), as well as intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System (IPSS) groups. MDS can be a precursor to the development of acute myeloid leukemia (AML). The efficacy of Inqovi is demonstrated by the rate of complete remission (CR) and the duration of CR, as well as hematologic improvement and transfusion independence in clinical trials.

Clinical studies have shown that Inqovi, when administered orally, has comparable efficacy to intravenous decitabine. The combination of decitabine with cedazuridine allows for an increased oral bioavailability of decitabine, ensuring that more of the drug is available for therapeutic action. This combination has provided a convenient oral option for patients who otherwise would require intravenous administration of decitabine alone.

Efficacy of Onureg for Leukemia

Onureg (azacitidine) is a nucleoside metabolic inhibitor indicated for the continued treatment of adult patients with acute myeloid leukemia (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 is primarily measured by the overall survival (OS) of patients and the relapse-free survival (RFS) as compared to placebo.

The approval of Onureg is supported by a randomized, double-blind, placebo-controlled trial that demonstrated a significant improvement in overall survival for patients taking Onureg compared to those who received a placebo. This trial included patients with AML in remission who were not candidates for hematopoietic stem cell transplantation (HSCT) at the time of study entry. The use of Onureg as maintenance therapy in this patient population has provided a meaningful extension of survival, which is a significant advancement in the management of AML.