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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR IDELALISIB


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All Clinical Trials for Idelalisib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00836914 ↗ Study to Investigate Effects of CAL-101 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber Completed Gilead Sciences Phase 1 2009-02-01 The purpose of this study is to determine the safety and effect of CAL-101 in subjects with allergic rhinitis.
NCT01088048 ↗ Study to Investigate Idelalisib in Combination With Chemotherapeutic Agents, Immunomodulatory Agents and Anti-CD20 Monoclonal Antibody (mAb) in Participants With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma, Mantle Cell Lymphoma or Completed Gilead Sciences Phase 1 2010-03-25 The primary objective of the study is to evaluate the safety of idelalisib in combination with an anti-CD20 monoclonal antibody (mAb), a chemotherapeutic agent, a mammalian target of rapamycin (mTOR) inhibitor, a protease inhibitor, an antiangiogenic agent, and/or an immunomodulatory agent in participants with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL).
NCT01090414 ↗ An Extension Study for Subjects Who Are Deriving Benefit With Idelalisib (GS-1101; CAL-101) Following Completion of a Prior Idelalisib Study Terminated Gilead Sciences Phase 1/Phase 2 2010-03-22 This is a long-term safety extension study of idelalisib (GS-1101; CAL-101) in patients with hematologic malignancies who complete other idelalisib studies. It provides the opportunity for patients to continue treatment as long as the patient is deriving clinical benefit. Patients will be followed according to the standard of care as appropriate for their type of cancer. The dose of idelalisib will generally be the same as the dose that was administered at the end of the prior study, but may be titrated up to improve clinical response or down for toxicity. Patients will be withdrawn from the study if they develop progressive disease, unacceptable toxicity related to idelalisib, or if they no longer derive clinical benefit in the opinion of the investigator.
NCT01203930 ↗ A Study of Idelalisib and Rituximab in Elderly Patients With Untreated CLL or SLL Terminated Gilead Sciences Phase 2 2010-10-01 This study is to evaluate the safety and clinical activity of idelalisib alone and in combination with rituximab in patients with CLL or SLL. This Phase 2 study will be the first time that idelalisib is administered to previously untreated patients with hematologic malignancies. Idelalisib has demonstrated clinical activity as a single agent in relapsed or refractory CLL and SLL with acceptable toxicity, which supports its evaluation in previously untreated patients. The study population is limited to patients over 65 years of age because younger patients are generally appropriate for standard immunochemotherapy regimens that are highly active. Since the mechanism of action of idelalisib is distinct from rituximab, it is hypothesized that the combination will be more active than either agent alone. This study will establish initial safety and clinical activity of idelalisib in combination with rituximab in patients with CLL or SLL. Cohort 2 of this study will establish safety and clinical activity of idelalisib alone in subjects with untreated CLL or SLL.
NCT01282424 ↗ Efficacy and Safety Study of Idelalisib in Participants With Indolent B-Cell Non-Hodgkin Lymphomas Completed Gilead Sciences Phase 2 2011-03-18 The primary objective will be to assess the overall response rate and to evaluate the efficacy and safety of idelalisib (IDELA; GS-1101) in participants with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg taken twice per day. Treatment with idelalisib can continue in compliant participants as long as the study is still ongoing and the participants appear to be benefiting from treatment with acceptable safety.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Idelalisib

Condition Name

Condition Name for Idelalisib
Intervention Trials
Chronic Lymphocytic Leukemia 20
Small Lymphocytic Lymphoma 10
Follicular Lymphoma 9
Marginal Zone Lymphoma 4
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Condition MeSH

Condition MeSH for Idelalisib
Intervention Trials
Leukemia, Lymphocytic, Chronic, B-Cell 34
Leukemia, Lymphoid 33
Leukemia 30
Lymphoma 29
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Clinical Trial Locations for Idelalisib

Trials by Country

Trials by Country for Idelalisib
Location Trials
United States 351
France 40
Australia 40
United Kingdom 32
Canada 29
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Trials by US State

Trials by US State for Idelalisib
Location Trials
New York 27
California 26
Texas 21
Washington 19
Florida 17
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Clinical Trial Progress for Idelalisib

Clinical Trial Phase

Clinical Trial Phase for Idelalisib
Clinical Trial Phase Trials
Phase 4 1
Phase 3 11
Phase 2 25
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Clinical Trial Status

Clinical Trial Status for Idelalisib
Clinical Trial Phase Trials
Terminated 21
Completed 15
Active, not recruiting 14
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Clinical Trial Sponsors for Idelalisib

Sponsor Name

Sponsor Name for Idelalisib
Sponsor Trials
Gilead Sciences 39
National Cancer Institute (NCI) 7
OHSU Knight Cancer Institute 3
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Sponsor Type

Sponsor Type for Idelalisib
Sponsor Trials
Industry 55
Other 36
NIH 7
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Idelalisib: A Comprehensive Review of Clinical Trials, Market Analysis, and Projections

Introduction

Idelalisib, marketed as Zydelig, is a phosphatidylinositol 3-kinase (PI3K) delta inhibitor that was initially approved by the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of relapsed follicular lymphoma (FL) and small lymphocytic lymphoma (SLL). Here, we delve into the clinical trials history, market analysis, and the eventual withdrawal of idelalisib from certain indications.

Clinical Trials History

Pre-Marketing Trials

Idelalisib underwent extensive clinical trials before its accelerated approval. A key Phase 2 study, which led to its approval, showed an overall response rate of 54% in patients with FL and 58% in patients with SLL[3].

Post-Marketing Trials and Safety Concerns

Following its approval, idelalisib was subject to post-marketing registry trials to confirm its efficacy and safety. However, these trials were terminated in 2016 due to serious adverse effects, including increased risks of serious adverse events (SAEs), fatal adverse events (FAEs), and all-cause mortality. The cumulative relative risk for SAEs was 1.86, for FAEs was 3.30, and for death was 1.35 by the initial post-marketing period[1][4].

Failure to Complete Mandatory Follow-Up Trials

Despite the FDA's requirement for follow-up trials to confirm the drug's efficacy and safety, Gilead failed to complete these studies. The evolving treatment landscape for FL and SLL, with other effective treatments like Imbruvica (ibrutinib), made patient enrollment challenging[2].

Market Analysis

Sales and Revenue

During its market authorization from 2014 to 2022, idelalisib generated significant revenue for Gilead, with cumulative sales of $842 million. However, annual sales declined steadily from $168 million in 2016 to $62 million in 2021[1][4].

Market Impact and Competition

The lymphoproliferative disorder treatment market, which includes treatments for conditions like FL and SLL, is projected to grow significantly. By 2037, this market is expected to reach $13.22 billion, with immunomodulatory agents, such as idelalisib, playing a crucial role. However, the withdrawal of idelalisib from certain indications has impacted its market share, especially with the presence of other effective treatments[5].

Regulatory and Safety Issues

Accelerated Approval Pathway

Idelalisib's approval through the FDA's accelerated approval pathway highlighted the need for closer scrutiny of drugs approved under this program. The pathway allows for earlier approval of drugs that address unmet medical needs, but it requires subsequent confirmation of efficacy and safety through post-marketing trials[2].

Voluntary Withdrawal

In 2022, Gilead voluntarily withdrew idelalisib from the market for the indications of FL and SLL due to the failure to complete the required follow-up trials and the evident safety risks. The drug remains available for chronic lymphocytic leukemia (CLL) in the U.S. and for CLL, SLL, and FL in several other countries[2].

Mechanism of Action and Clinical Development

Mechanism of Action

Idelalisib works by inhibiting the PI3K delta protein, which is crucial for the activation, proliferation, and survival of B lymphocytes. This mechanism is particularly effective in treating B-cell leukemias and lymphomas[3].

Clinical Development Program

Gilead's clinical development program for idelalisib included multiple Phase 3 studies evaluating the drug in combination with other approved therapies for CLL and indolent non-Hodgkin's lymphoma (iNHL). However, several of these trials were terminated or failed to enroll sufficient patients[3][4].

Market Projections and Future Outlook

Lymphoproliferative Disorder Treatment Market

The global lymphoproliferative disorder treatment market is expected to grow at a CAGR of 6.7% from 2025 to 2037, driven by increasing awareness and the development of novel therapeutics. While idelalisib's withdrawal from certain indications affects its market share, other immunomodulatory agents are expected to dominate the market[5].

Regional Market Trends

North America is anticipated to hold the largest revenue share of the lymphoproliferative disorder treatment market, followed by Europe and the Asia Pacific region. The growth in these regions is attributed to the increasing incidence of lymphoproliferative disorders and advancements in research and development[5].

Key Takeaways

  • Clinical Trials: Idelalisib's post-marketing trials were terminated due to serious adverse effects, and mandatory follow-up trials were not completed.
  • Market Analysis: Despite significant initial revenue, idelalisib's sales declined due to safety concerns and competition from other treatments.
  • Regulatory Issues: The drug's withdrawal highlights the need for stricter oversight of the FDA's accelerated approval pathway.
  • Mechanism of Action: Idelalisib inhibits PI3K delta, a critical protein in B-cell malignancies.
  • Market Projections: The lymphoproliferative disorder treatment market is expected to grow, but idelalisib's market share is impacted by its withdrawal.

FAQs

What is idelalisib, and how does it work?

Idelalisib is a PI3K delta inhibitor that works by blocking the phosphatidylinositol 3-kinase delta protein, which is crucial for the activation, proliferation, and survival of B lymphocytes.

Why was idelalisib withdrawn from the market for certain indications?

Idelalisib was withdrawn due to the failure to complete mandatory follow-up clinical trials to confirm its efficacy and safety, along with reported serious adverse effects.

What are the current market trends in lymphoproliferative disorder treatments?

The market is expected to grow at a CAGR of 6.7% from 2025 to 2037, driven by increasing awareness and the development of novel therapeutics, with immunomodulatory agents dominating the market.

How does idelalisib compare to other treatments like Imbruvica?

Idelalisib faced competition from other effective treatments like Imbruvica (ibrutinib), which has full FDA approval and is widely used for treating SLL, CLL, and other cancers.

What is the future outlook for Gilead Sciences in the cancer therapy market?

Gilead is actively pursuing other cancer therapies, having acquired companies like Kite Pharma and Immunomedics, and is developing new treatments such as Trodelvy (sacituzumab govitecan-hziy).

Sources

  1. Clinical Trials Portfolio and Regulatory History of Idelalisib ... - PubMed
  2. Gilead Withdraws Cancer Drug Amidst Uncompleted Follow-Up Trials - BioSpace
  3. Gilead Announces Interim Phase 2 Data for Idelalisib Showing ... - Gilead
  4. Clinical Trials Portfolio and Regulatory History of Idelalisib in ... - JAMA Internal Medicine
  5. Lymphoproliferative Disorder Treatment Market Outlook 2025-2037 - Research Nester

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