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CLINICAL TRIALS PROFILE FOR ZYDELIG

All Clinical Trials for Zydelig

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01620216 ↗	Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia	Terminated	National Cancer Institute (NCI)	Phase 2	2012-05-11	This phase II trial studies how well targeted therapy works in treating patients with acute lymphoblastic leukemia or acute myelogenous leukemia that has come back after a period of improvement or does not respond to treatment. Testing patients' blood or bone marrow to find out if their type of cancer may be sensitive to a specific drug may help doctors choose more effective treatments. Dasatinib, sunitinib malate, sorafenib tosylate, ponatinib hydrochloride, pacritinib, ruxolitinib, and idelalisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving targeted therapy based on cancer type may be an effective treatment for acute lymphoblastic leukemia or acute myelogenous leukemia.
NCT01620216 ↗	Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia	Terminated	Oregon Health and Science University	Phase 2	2012-05-11	This phase II trial studies how well targeted therapy works in treating patients with acute lymphoblastic leukemia or acute myelogenous leukemia that has come back after a period of improvement or does not respond to treatment. Testing patients' blood or bone marrow to find out if their type of cancer may be sensitive to a specific drug may help doctors choose more effective treatments. Dasatinib, sunitinib malate, sorafenib tosylate, ponatinib hydrochloride, pacritinib, ruxolitinib, and idelalisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving targeted therapy based on cancer type may be an effective treatment for acute lymphoblastic leukemia or acute myelogenous leukemia.
NCT01620216 ↗	Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia	Terminated	OHSU Knight Cancer Institute	Phase 2	2012-05-11	This phase II trial studies how well targeted therapy works in treating patients with acute lymphoblastic leukemia or acute myelogenous leukemia that has come back after a period of improvement or does not respond to treatment. Testing patients' blood or bone marrow to find out if their type of cancer may be sensitive to a specific drug may help doctors choose more effective treatments. Dasatinib, sunitinib malate, sorafenib tosylate, ponatinib hydrochloride, pacritinib, ruxolitinib, and idelalisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving targeted therapy based on cancer type may be an effective treatment for acute lymphoblastic leukemia or acute myelogenous leukemia.
NCT02332980 ↗	Pembrolizumab Alone or With Idelalisib or Ibrutinib in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Other Low-Grade B-Cell Non-Hodgkin Lymphomas	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2015-02-19	This phase II trial studies how well pembrolizumab alone or with idelalisib or ibrutinib works in treating patients with chronic lymphocytic leukemia or other low-grade B-cell non-Hodgkin lymphomas that have returned after a period of improvement (relapsed) or have not responded to treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Idelalisib and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab alone or with idelalisib or ibrutinib may be an effective treatment in patients with chronic lymphocytic leukemia or other low-grade B-cell non-Hodgkin lymphomas.

Clinical Trial Conditions for Zydelig

Condition Name

Condition Name for Zydelig
Intervention	Trials
Recurrent Small Lymphocytic Lymphoma	4
Recurrent Chronic Lymphocytic Leukemia	4
Waldenstrom Macroglobulinemia	3
Recurrent Acute Myeloid Leukemia	2

Condition MeSH

Condition MeSH for Zydelig
Intervention	Trials
Leukemia, Lymphoid	9
Leukemia, Lymphocytic, Chronic, B-Cell	8
Leukemia	8
Lymphoma	7

Clinical Trial Locations for Zydelig

Trials by Country

Trials by Country for Zydelig
Location	Trials
United States	39
Japan	10
France	6
United Kingdom	5
Korea, Republic of	3

Trials by US State

Trials by US State for Zydelig
Location	Trials
Oregon	4
Maryland	3
Georgia	2
Virginia	2
Florida	2

Clinical Trial Progress for Zydelig

Clinical Trial Phase

Clinical Trial Phase for Zydelig
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	6
Phase 1/Phase 2	1

Clinical Trial Status

Clinical Trial Status for Zydelig
Clinical Trial Phase	Trials
Active, not recruiting	5
Terminated	3
Recruiting	2

Clinical Trial Sponsors for Zydelig

Sponsor Name

Sponsor Name for Zydelig
Sponsor	Trials
Gilead Sciences	5
National Cancer Institute (NCI)	5
OHSU Knight Cancer Institute	3

Sponsor Type

Sponsor Type for Zydelig
Sponsor	Trials
Other	20
Industry	8
NIH	5

Zydelig (Idelalisib): A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction

Zydelig, also known as idelalisib, is a first-in-class PI3K inhibitor developed by Gilead Sciences for the treatment of certain B-cell blood cancers. Since its approval in 2014, the drug has faced significant challenges, including safety concerns, changing market dynamics, and regulatory actions. Here is a detailed update on the clinical trials, market analysis, and projections for Zydelig.

FDA Approval and Initial Indications

Zydelig was initially approved by the FDA in July 2014 for the treatment of relapsed chronic lymphocytic leukemia (CLL), relapsed follicular B-cell non-Hodgkin lymphoma, and relapsed small lymphocytic lymphoma (SLL), all in patients who had received at least two prior systemic therapies[2][3].

Clinical Trials and Safety Concerns

In 2016, Gilead Sciences halted six clinical trials involving Zydelig due to reports of serious adverse events, including multiple deaths, among participants. These trials were testing Zydelig in combination with other therapies in newly diagnosed leukemia and lymphoma patients. The FDA and European regulators began reviewing the findings, leading to a significant setback for the drug's expansion into frontline treatments[1][3].

Impact on Clinical Trials

The halted trials were part of Gilead's efforts to expand Zydelig's use into first-line therapies. However, the serious side effects observed led to the cessation of these studies. The FDA emphasized that Zydelig is not approved for previously untreated CLL and that healthcare professionals should be cautious when prescribing the drug in combination with other therapies[1][3].

Market Analysis and Changing Landscape

The market for B-cell blood cancers has evolved significantly since Zydelig's approval. Other treatments, such as Imbruvica (ibrutinib) from Johnson & Johnson and AbbVie, have gained prominence and expanded their indications to include newly diagnosed patients. This competition has significantly impacted Zydelig's market position.

Withdrawal of Accelerated Approvals

In 2022, Gilead withdrew two indications for Zydelig that were granted under the accelerated approval pathway. The indications for relapsed follicular lymphoma (FL) and relapsed small lymphocytic lymphoma (SLL) were pulled due to the failure to complete an FDA-mandated confirmatory trial. This decision was influenced by the changing treatment landscape and the availability of more effective treatments[2].

Competitive Landscape

Imbruvica, a BTK inhibitor, has become a dominant player in the treatment of CLL and SLL, including newly diagnosed patients. Other treatments have also emerged, making the market more competitive. For instance, AbbVie's ABT-199 (venetoclax) has been used in combination with Rituxan and Imbruvica, further challenging Zydelig's position[2][3].

Efficacy and Benefits

Despite the challenges, Zydelig has shown significant efficacy in certain settings. For example, in a Phase 3 study, Zydelig in combination with bendamustine and rituximab demonstrated a statistically significant benefit in progression-free survival (PFS) for patients with relapsed CLL. The study found a 67% reduction in the risk of disease progression or death compared to bendamustine and rituximab alone[4].

Financial Performance and Projections

Gilead Sciences' financial reports indicate that while Zydelig has not met initial blockbuster sales estimates, it still contributes to the company's oncology portfolio. However, the drug's sales have been overshadowed by other successful oncology products like Yescarta and Trodelvy. The company's overall oncology sales have seen growth, but Zydelig's specific performance has been muted due to the competitive landscape and regulatory issues[5].

Key Takeaways

• Clinical Trials: Zydelig's expansion into frontline treatments was halted due to serious adverse events.
• Market Analysis: The drug faces significant competition from other treatments like Imbruvica and venetoclax.
• Efficacy: Zydelig remains effective in certain settings, such as relapsed CLL when combined with other therapies.
• Regulatory Actions: Two accelerated approvals for FL and SLL were withdrawn due to the failure to complete confirmatory trials.
• Financial Performance: While contributing to Gilead's oncology portfolio, Zydelig's sales have not met initial expectations.

FAQs

What is Zydelig used for?

Zydelig is approved for the treatment of relapsed chronic lymphocytic leukemia (CLL) in combination with rituximab, and for relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma in patients who have received at least two prior systemic therapies[1][2].

Why were clinical trials for Zydelig halted?

Clinical trials for Zydelig were halted due to reports of serious adverse events, including multiple deaths, among participants when the drug was used in combination with other therapies in newly diagnosed patients[1][3].

What is the current market position of Zydelig?

Zydelig faces significant competition from other treatments like Imbruvica and venetoclax, which have expanded their indications to include newly diagnosed patients. This competition has impacted Zydelig's market position and sales[2][3].

What were the results of the Phase 3 study for Zydelig in relapsed CLL?

The Phase 3 study showed a statistically significant benefit in progression-free survival (PFS) for patients with relapsed CLL when Zydelig was used in combination with bendamustine and rituximab. There was a 67% reduction in the risk of disease progression or death compared to bendamustine and rituximab alone[4].

Why were the accelerated approvals for Zydelig withdrawn?

The accelerated approvals for relapsed follicular lymphoma and relapsed small lymphocytic lymphoma were withdrawn due to the failure to complete an FDA-mandated confirmatory trial, coupled with the changing treatment landscape and availability of more effective treatments[2].

Sources

1. FDA Alerts Healthcare Professionals About Clinical Trials with Zydelig (Idelalisib) in Combination with Other Cancer Medicines. FDA, 14 Mar. 2016.
2. Gilead pulls 2 cancer accelerated approvals as changing lymphoma landscape disrupts. FiercePharma, 24 Jan. 2022.
3. Zydelig 'dead in the water' after trial deaths force Gilead to stop frontline studies. FiercePharma, 15 Mar. 2016.
4. Phase 3 Results for Zydelig With Bendamustine and Rituximab for Relapsed Chronic Lymphocytic Leukemia (CLL) Presented at American Society of Hematology Annual Meeting. Gilead Sciences, 2015.
5. Gilead Sciences Announces Second Quarter 2024 Financial Results. Gilead Sciences, 8 Aug. 2024.