You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR ICLUSIG


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Iclusig

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00660920 ↗ Safety Study of AP24534 to Treat Chronic Myelogenous Leukemia (CML) and Other Hematological Malignancies Completed Ariad Pharmaceuticals Phase 1 2008-06-01 The purpose of this study is to determine the maximum tolerated dose or a recommended dose of oral AP24534 in a defined schedule in patients with refractory or advanced chronic myelogenous leukemia and other refractory hematologic malignancies.
NCT01207440 ↗ Ponatinib for Chronic Myeloid Leukemia (CML) Evaluation and Ph+ Acute Lymphoblastic Leukemia (ALL) Completed Ariad Pharmaceuticals Phase 2 2010-09-30 The purpose of this study is to determine the efficacy of ponatinib in patients with chronic myeloid leukemia (CML) in chronic phase (CP), accelerated phase (AP) or blast phase (BP) or with philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) who either are resistant or intolerant to either dasatinib or nilotinib, or have the (T)hreonine-315-(I)soleucine (T315I) mutation.
NCT01424982 ↗ Combination Chemotherapy and Ponatinib Hydrochloride in Treating Patients With Acute Lymphoblastic Leukemia Recruiting Ariad Pharmaceuticals Phase 2 2011-10-05 This phase II trial studies the side effects and how well combination chemotherapy and ponatinib hydrochloride work in treating patients with acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone, 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. Ponatinib hydrochloride may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy and ponatinib hydrochloride may be an effective treatment for acute lymphoblastic leukemia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Iclusig

Condition Name

Condition Name for Iclusig
Intervention Trials
Acute Lymphoblastic Leukemia 6
Refractory Acute Lymphoblastic Leukemia 4
Philadelphia Chromosome Positive 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Iclusig
Intervention Trials
Leukemia 19
Leukemia, Myeloid 16
Leukemia, Myelogenous, Chronic, BCR-ABL Positive 12
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Iclusig

Trials by Country

Trials by Country for Iclusig
Location Trials
United States 95
France 19
China 18
Poland 12
Japan 12
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Iclusig
Location Trials
Texas 12
Oregon 8
Maryland 5
Michigan 5
California 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Iclusig

Clinical Trial Phase

Clinical Trial Phase for Iclusig
Clinical Trial Phase Trials
Phase 3 3
Phase 2 18
Phase 1/Phase 2 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Iclusig
Clinical Trial Phase Trials
Recruiting 12
Completed 6
Active, not recruiting 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Iclusig

Sponsor Name

Sponsor Name for Iclusig
Sponsor Trials
Ariad Pharmaceuticals 11
National Cancer Institute (NCI) 7
M.D. Anderson Cancer Center 6
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Iclusig
Sponsor Trials
Industry 19
Other 19
NIH 7
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

ICLUSIG (Ponatinib): Clinical Trials Update, Market Analysis, and Projections

Introduction to ICLUSIG

ICLUSIG, also known as ponatinib, is a third-generation tyrosine kinase inhibitor (TKI) developed to treat certain types of blood cancers, including chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Here, we will delve into the recent clinical trials, market analysis, and projections for this significant cancer treatment.

Clinical Trials Update

PACE Trial

The pivotal Phase 2 PACE trial is one of the longest and largest studies evaluating ICLUSIG in patients with CML, particularly those who have failed or are intolerant to prior TKI therapies. The final five-year results, published in the journal Blood, demonstrated that ICLUSIG provided lasting clinically meaningful responses, even with dose reductions, in heavily pre-treated chronic-phase CML patients. This trial supported the FDA Accelerated Approval Program and highlighted ICLUSIG's efficacy in patients with the T315I mutation, for whom no other TKI is indicated[1].

OPTIC Trial

The OPTIC trial is an ongoing randomized, dose-ranging trial designed to optimize the treatment regimen for ICLUSIG in patients with resistant chronic-phase CML. The trial evaluates three starting doses of ICLUSIG (45 mg, 30 mg, and 15 mg) and demonstrates that the optimal benefit-risk profile is achieved with a starting dose of 45 mg, followed by a reduction to 15 mg upon achieving a BCR-ABL1IS level of ≤1%. The results show a clinically manageable safety and arterial occlusive event (AOE) profile, with 73% of patients maintaining their response at a median follow-up of 32 months[3].

PhALLCON Trial

The Phase 3 PhALLCON trial compared ICLUSIG plus reduced-intensity chemotherapy against imatinib plus reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL. The trial met its primary endpoint, showing that ICLUSIG achieved higher rates of minimal residual disease (MRD)-negative complete remission compared to imatinib. This study reinforces ICLUSIG's potential to become the standard of care in Ph+ ALL, given its superior efficacy and manageable safety profile[4][5].

Market Analysis

Current Market Status

The global ICLUSIG market is analyzed based on various factors, including market size, revenue, volume share, and competitive landscape. The market report for 2024 provides historical data from 2019 to 2023 and forecasts from 2025 to 2031. Key factors affecting the market include the efficacy and safety profile of ICLUSIG, particularly its ability to treat patients with resistant mutations like T315I[2].

Segment Analysis

The market is segmented by type, with the 45 mg and 15 mg doses being significant. The 45 mg dose has a significant impact due to its use as a starting dose, followed by reduction to 15 mg upon achieving the desired response. This dosing regimen is supported by the OPTIC trial results, which show optimal benefit-risk with this approach[3].

Regional Analysis

The global ICLUSIG market is expected to be dominated by regions with high prevalence rates of CML and Ph+ ALL, as well as regions with advanced healthcare systems that can adopt and integrate new treatments effectively.

Competitive Analysis

ICLUSIG competes in the TKI market, which includes first-generation TKIs like imatinib (Gleevec) and other third-generation TKIs. However, ICLUSIG's unique ability to target all known BCR-ABL1 mutations, including the T315I mutation, positions it as a valuable option for patients who have failed or are intolerant to prior therapies[4].

Market Projections

Growth Rate and CAGR

The CML market, which includes ICLUSIG, is expected to grow at a significant CAGR during the forecast period from 2025 to 2031. This growth is driven by the increasing prevalence of CML, the efficacy of ICLUSIG in treating resistant cases, and the expanding label indications, including Ph+ ALL[2].

Regional Dominance

North America and Europe are expected to dominate the global ICLUSIG market due to their advanced healthcare systems, high adoption rates of new treatments, and significant patient populations.

Customization and Additional Data

Market reports can be customized to provide detailed data at the global, regional, and country levels, as well as company-specific data. This customization helps in making informed decisions and strategizing market entry or expansion[2].

Safety and Efficacy Profile

Clinical Benefits

ICLUSIG has demonstrated lasting clinically meaningful responses in patients with CML and Ph+ ALL. The drug's ability to inhibit all known BCR-ABL1 mutations makes it a crucial treatment option for patients who have failed other TKIs[1][4].

Safety Profile

While ICLUSIG is associated with arterial occlusive events (AOEs), the OPTIC trial data suggest that these events are manageable with a response-based dosing regimen. The trial showed that 10% of patients experienced an AOE of any grade, with 5% experiencing Grade 3 or higher[3].

Expert Insights

"The PACE trial is among the longest and largest studies of patients with CP-CML who have received two or three prior TKIs, and the findings provide treating physicians with important updated information about the clinical benefits and safety profile of ICLUSIG." - Jorge Eduardo Cortes, M.D., Deputy Chair and Professor of Medicine, Department of Leukemia, MD Anderson Cancer Center[1].

"The publication of these data is an important milestone for the ICLUSIG clinical program as it shows that ICLUSIG continues to be an effective treatment option for appropriate patients whose prior TKIs have failed, including patients with the T315I mutation." - Frank Neumann, M.D., Ph.D., Senior Medical Director, Global Clinical Lead, ICLUSIG, Takeda[1].

Key Takeaways

  • Clinical Efficacy: ICLUSIG has shown significant efficacy in treating CML and Ph+ ALL, particularly in patients with resistant mutations.
  • Dosing Regimen: The OPTIC trial supports a starting dose of 45 mg, followed by reduction to 15 mg upon achieving ≤1% BCR-ABL1IS.
  • Market Growth: The global ICLUSIG market is projected to grow significantly from 2025 to 2031, driven by its unique efficacy profile and expanding label indications.
  • Safety Profile: While associated with AOEs, ICLUSIG's safety profile is manageable with the right dosing regimen.
  • Competitive Advantage: ICLUSIG's ability to target all known BCR-ABL1 mutations positions it as a valuable treatment option in the TKI market.

FAQs

Q: What is ICLUSIG used for?

ICLUSIG (ponatinib) is used to treat certain types of blood cancers, including chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), especially in patients who have failed or are intolerant to prior tyrosine kinase inhibitor (TKI) therapies.

Q: What are the key findings of the PACE trial?

The PACE trial demonstrated that ICLUSIG provides lasting clinically meaningful responses in heavily pre-treated CML patients, including those with the T315I mutation, and supports its use as an effective treatment option for these patients.

Q: What is the optimal dosing regimen for ICLUSIG according to the OPTIC trial?

The OPTIC trial suggests that the optimal benefit-risk profile for ICLUSIG is achieved with a starting dose of 45 mg, followed by a reduction to 15 mg upon achieving ≤1% BCR-ABL1IS.

Q: How does ICLUSIG compare to other TKIs in treating Ph+ ALL?

ICLUSIG has shown superior efficacy compared to imatinib in the PhALLCON trial, achieving higher rates of minimal residual disease (MRD)-negative complete remission and positioning it as a potential standard of care in Ph+ ALL.

Q: What are the potential side effects of ICLUSIG?

ICLUSIG is associated with arterial occlusive events (AOEs), but the OPTIC trial data indicate that these events are manageable with the right dosing regimen.

Sources

  1. Takeda Announces Publication of Final Data from ICLUSIG® (ponatinib) Pivotal Phase 2 PACE Trial in Blood. Takeda Oncology.
  2. Iclusig Market Report 2024 (Global Edition). Cognitive Market Research.
  3. Takeda to Present Positive Primary Analysis from Phase 2 OPTIC Trial of ICLUSIG (ponatinib). Takeda Oncology.
  4. Phase 3 Trial of ICLUSIG® (ponatinib) Met Primary Endpoint in Ph+ ALL. Takeda.
  5. Takeda's Iclusig tops Novartis' Gleevec decisively in Ph+ALL. FiercePharma.

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.