Inqovi: An All-oral Therapy Being Studied for AML Patients

Can an all-oral therapy help treat seniors with acute myeloid leukemia (AML)?

This June of 2025 started with the American Society of Clinical Oncology conference, where specialists presented the latest results from groundbreaking studies. 

In this article, you’ll learn the findings of a study testing an all-oral treatment for people with newly diagnosed AML who were unable to receive intensive chemotherapy.

A more convenient option for AML patients who can’t tolerate intensive therapy

Many people diagnosed with AML are over 75 or have other health conditions that make them unable to undergo intensive chemotherapy. A common treatment in this group has been azacitidine (Vidaza, BMS) combined with venetoclax (Venclexta, AbbVie), which was shown to be effective in the VIALE-A study. However, azacitidine requires patients to go to the clinic for injections over seven days every month, which can represent extra costs and decrease the quality of life for some individuals.

At ASCO, Dr. Amer Zedan presented a study that explored whether an all-oral treatment: decitabine-cedazuridine (Inqovi, Taiho Oncology) combined with venetoclax could provide similar benefits with greater convenience.

The study included 101 adults with newly diagnosed AML who were either age 75 or older or had other medical conditions that made them ineligible for standard induction chemotherapy. Patients took oral decitabine-cedazuridine for five days and venetoclax daily in 28-day treatment cycles.

Receiving oral therapies can reduce the treatment burden, especially for senior adults or those with mobility challenges. Understanding effectiveness in this population is important for informed treatment decisions.

Response rates showed encouraging effectiveness

• Complete remission (CR) rate was 46.5%, with a median time to reach it of 2.4 months. 
• Durability: 80% of patients who responded stayed in remission for at least 6 months, and after 1 year, 75.3% remained in complete remission.

These results are in line with the azacitidine-venetoclax combination, showing that an all-oral approach can be comparably effective in helping patients achieve and maintain remission.

Survival and safety outcomes

• Median overall survival (OS) was 15.5 months
• Side effects were present in 98% of patients; the most common were: fever with low white blood cell counts (49.5%), anemia (38.6%), and neutropenia (35.6%)

Median survival was similar to previous regimens used in this patient group. Although nearly all patients experienced side effects, they were expected and manageable.

The study also showed no interactions between decitabine-cedazuridine and venetoclax, meaning they can be taken together without reducing each other’s effectiveness. Ensuring compatibility between medications is important, especially in combination treatments where timing and drug levels can impact safety and outcomes.

Growing options for people with AML

In the future, the combination of decitabine-cedazuridine and venetoclax may offer a new oral-only treatment for AML patients who cannot receive intensive therapy. It has similar remission and survival outcomes as treatments requiring clinic visits for injections. For many, avoiding monthly injections could improve quality of life and reduce logistical challenges. 

Because the trial is still active but no longer enrolling new participants, talk with your healthcare team about available treatment options. These may include therapies that are approved by the FDA or newer treatments being studied in clinical trials. You can also continue exploring AML clinical trials and create an account to tailor your search based on your personal health profile and preferences by clicking the buttons below.

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Source: 

• An all-oral regimen of decitabine-cedazuridine (DEC-C) plus venetoclax (VEN) in patients (pts) with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive induction chemotherapy: Results from a phase 2 cohort of 101 pts.