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Last Updated: January 20, 2025

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CLINICAL TRIALS PROFILE FOR INQOVI


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All Clinical Trials for Inqovi

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT04655755 ↗ Venetoclax in Combination With ASTX727 for the Treatment of Treatment-Naive High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia Recruiting Astex Pharmaceuticals, Inc. Phase 1/Phase 2 2021-01-19 This phase I/II trial studies the side effects and best dose of venetoclax in combination with cedazuridine and decitabine (ASTX727) in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia who have not received prior treatment (treatment-naive). Chemotherapy drugs, such as venetoclax, cedazuridine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
NCT04655755 ↗ Venetoclax in Combination With ASTX727 for the Treatment of Treatment-Naive High-Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia Recruiting Genentech, Inc. Phase 1/Phase 2 2021-01-19 This phase I/II trial studies the side effects and best dose of venetoclax in combination with cedazuridine and decitabine (ASTX727) in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia who have not received prior treatment (treatment-naive). Chemotherapy drugs, such as venetoclax, cedazuridine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
NCT04340843 ↗ Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma Recruiting National Cancer Institute (NCI) Phase 2 2020-07-06 This phase II trial studies the effect of belinostat and SGI-110 (guadecitabine) or ASTX727 in treating patients with conventional chondrosarcoma that cannot be removed by surgery (unresectable) and has spread to other places in the body (metastatic). Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as guadecitabine and ASTX727, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving belinostat in combination with guadecitabine or ASTX727 may lower the chance of unresectable and metastatic chondrosarcoma growing or spreading.
NCT04093570 ↗ An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose) Enrolling by invitation Astex Pharmaceuticals, Inc. Phase 2 2019-09-30 Extension study for subjects who participated in a previous Astex-sponsored clinical study of ASTX727 (including, but not limited to ASTX727-01, ASTX727-02, ASTX727-04).
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for Inqovi

Condition Name

115550-10123456789101112Acute Myeloid LeukemiaRecurrent Acute Myeloid LeukemiaChronic Myelomonocytic LeukemiaRefractory Acute Myeloid Leukemia[disabled in preview]
Condition Name for Inqovi
Intervention Trials
Acute Myeloid Leukemia 11
Recurrent Acute Myeloid Leukemia 5
Chronic Myelomonocytic Leukemia 5
Refractory Acute Myeloid Leukemia 5
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Condition MeSH

161212900246810121416LeukemiaLeukemia, MyeloidLeukemia, Myeloid, AcutePreleukemia[disabled in preview]
Condition MeSH for Inqovi
Intervention Trials
Leukemia 16
Leukemia, Myeloid 12
Leukemia, Myeloid, Acute 12
Preleukemia 9
[disabled in preview] 0
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Clinical Trial Locations for Inqovi

Trials by Country

+
Trials by Country for Inqovi
Location Trials
United States 51
Australia 1
Canada 1
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Trials by US State

+
Trials by US State for Inqovi
Location Trials
Texas 12
New York 5
California 4
Maryland 3
Illinois 3
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Clinical Trial Progress for Inqovi

Clinical Trial Phase

36.0%28.0%36.0%00123456789Phase 2Phase 1/Phase 2Phase 1[disabled in preview]
Clinical Trial Phase for Inqovi
Clinical Trial Phase Trials
Phase 2 9
Phase 1/Phase 2 7
Phase 1 9
[disabled in preview] 0
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Clinical Trial Status

44.0%44.0%8.0%00123456789101112RecruitingNot yet recruitingSuspended[disabled in preview]
Clinical Trial Status for Inqovi
Clinical Trial Phase Trials
Recruiting 11
Not yet recruiting 11
Suspended 2
[disabled in preview] 1
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Clinical Trial Sponsors for Inqovi

Sponsor Name

trials01234567891011National Cancer Institute (NCI)M.D. Anderson Cancer CenterAstex Pharmaceuticals, Inc.[disabled in preview]
Sponsor Name for Inqovi
Sponsor Trials
National Cancer Institute (NCI) 10
M.D. Anderson Cancer Center 9
Astex Pharmaceuticals, Inc. 6
[disabled in preview] 2
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Sponsor Type

50.0%25.0%25.0%0-20246810121416182022OtherNIHIndustry[disabled in preview]
Sponsor Type for Inqovi
Sponsor Trials
Other 20
NIH 10
Industry 10
[disabled in preview] 0
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Clinical Trials, Market Analysis, and Projections for Inqovi

Introduction to Inqovi

Inqovi, a fixed-dose combination of decitabine and cedazuridine, is a groundbreaking oral therapy approved by the FDA for the treatment of adults with intermediate- or high-risk myelodysplastic syndromes (MDS), including those with chronic myelomonocytic leukemia (CMML)[1][3][4].

Clinical Trials Overview

The FDA approval of Inqovi was based on data from two key clinical trials:

Phase II and Phase III Trials

  • The Phase II trial (ASTX727-01-B) and the Phase III trial (ASTX727-02) were open-label, randomized, 2-cycle, 2-sequence crossover studies. These trials compared the efficacy and safety of oral Inqovi with intravenous decitabine in patients with MDS or CMML.
  • Patients were randomized to receive either Inqovi in cycle 1 followed by intravenous decitabine in cycle 2, or the reverse sequence. From cycle 3 onwards, all patients received Inqovi until disease progression, death, or unacceptable toxicity[3][4].

Key Findings

  • The primary endpoint was the 5-day cumulative decitabine exposure, which showed that Inqovi achieved exposures equivalent to those of intravenous decitabine. The ratio of the geometric mean of the 5-day total decitabine AUC (area under the plasma concentration versus time curve) between Inqovi and intravenous decitabine was 99% (90% CI: 93%, 106%)[3].
  • Secondary endpoints included overall response rate, duration of response, and transfusion independence. In the Phase III study, 21% of patients achieved a complete response, with a median duration of complete response of 7.5 months. Approximately 53% of patients who were dependent on red blood cell and/or platelet transfusions at baseline became independent of these transfusions during any 56-day post-baseline period[3][4].

Safety Profile

The safety profile of Inqovi was evaluated based on pooled data from 208 patients across both trials.

Common Adverse Reactions

  • The most common adverse reactions (≥20%) included fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia, and increased transaminase levels[1][3].

Serious Adverse Reactions

  • Serious adverse reactions (>5%) included febrile neutropenia (30%), pneumonia (14%), and sepsis (13%). Adverse events leading to death included sepsis, septic shock, pneumonia, respiratory failure, cerebral hemorrhage, and sudden death[1].

Market Analysis

Current Market Size

  • As of 2022, the global myelodysplastic syndrome drug market was valued at approximately USD 2.39 billion[2].

Growth Projections

  • The market is expected to grow at a CAGR of 9.5% between 2023 and 2032, reaching a projected value of USD 5.79 billion by 2032[2].

Market Segments

  • The market is segmented by type (hypomethylating agents, immunomodulatory drugs, and anti-anemics), route of administration (oral and parenteral), and end-users (hospitals, clinics, and other end-users). Inqovi, being an orally administered hypomethylating agent, fits into a significant and growing segment of this market[2].

Impact of Inqovi on the Market

Unique Selling Point

  • Inqovi is the first and only orally administered hypomethylating agent approved for the treatment of MDS and CMML, offering a significant advantage over traditional intravenous therapies by reducing the need for frequent hospital visits[1][3].

Patient Benefits

  • The oral formulation of Inqovi enhances patient compliance and quality of life by allowing treatment to be administered at home. This is particularly beneficial during the COVID-19 pandemic, as it reduces the risk of exposure to healthcare facilities[1].

Market Expansion

  • The approval and adoption of Inqovi are expected to drive growth in the MDS drug market. Its unique oral administration and equivalent efficacy to intravenous decitabine make it an attractive option for both patients and healthcare providers[2].

Expert Insights and Statistics

FDA Perspective

  • "The FDA remains committed to providing additional treatments to patients during the coronavirus pandemic. In this case, the FDA is making available an oral outpatient treatment option that can reduce the need for frequent visits to health care facilities," said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence[1].

Clinical Trial Statistics

  • In the Phase III study, 21% of patients achieved a complete response, and approximately 50% of patients who were previously dependent on transfusions no longer required them during an 8-week period[1][3].

Key Takeaways

  • Clinical Trials: Inqovi's approval was based on Phase II and Phase III trials showing equivalent efficacy and safety compared to intravenous decitabine.
  • Safety Profile: Common adverse reactions include fatigue, constipation, and hemorrhage, with serious adverse reactions such as febrile neutropenia and pneumonia.
  • Market Analysis: The global MDS drug market is projected to grow significantly, with Inqovi playing a crucial role due to its oral administration and patient benefits.
  • Impact: Inqovi enhances patient compliance and quality of life, and its approval is expected to drive market growth.

FAQs

What is Inqovi used for?

Inqovi is used to treat adults with myelodysplastic syndromes (MDS), including those with chronic myelomonocytic leukemia (CMML)[1][3][4].

What are the benefits of Inqovi?

Inqovi offers the benefit of oral administration, reducing the need for frequent hospital visits. It also achieves equivalent efficacy to intravenous decitabine and helps patients become independent of transfusions[1][3].

What were the key findings of the clinical trials for Inqovi?

The clinical trials showed that Inqovi achieved exposures equivalent to intravenous decitabine, with 21% of patients achieving a complete response and approximately 53% of transfusion-dependent patients becoming transfusion-independent[3][4].

What is the projected market size for MDS drugs by 2032?

The global MDS drug market is expected to reach USD 5.79 billion by 2032, growing at a CAGR of 9.5% from 2023 to 2032[2].

What are the common adverse reactions associated with Inqovi?

Common adverse reactions include fatigue, constipation, hemorrhage, myalgia, and others, with serious adverse reactions such as febrile neutropenia, pneumonia, and sepsis[1][3].

Sources

  1. FDA Approves Inqovi, a New Oral Combination Therapy, for Patients ... - Oncology Practice Management.
  2. Myelodysplastic Syndrome Drug Market Size | CAGR of 9.5% - Market.us.
  3. Summary Basis of Decision for Inqovi - Health Canada.
  4. Drug Trials Snapshots: INQOVI - FDA - FDA.gov.

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