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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR PIRTOBRUTINIB


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All Clinical Trials for Pirtobrutinib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04662255 ↗ Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) Recruiting Loxo Oncology, Inc. Phase 3 2021-03-05 This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare LOXO-305 to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.
NCT04666038 ↗ Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With CLL or SLL Recruiting Loxo Oncology, Inc. Phase 3 2021-03-09 This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.
NCT04849416 ↗ A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia) Recruiting Eli Lilly and Company Phase 2 2021-05-14 A study of the safety, side effects, and effectiveness of LOXO-305 in Chinese adults with lymphoma or chronic leukemia who have already had standard of care treatment. Participation could last up to four years.
NCT04965493 ↗ A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Recruiting Loxo Oncology, Inc. Phase 3 2021-09-20 The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.
NCT05023980 ↗ A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Recruiting Loxo Oncology, Inc. Phase 3 2021-09-23 The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.
NCT05024045 ↗ Study of Oral LOXO-338 in Patients With Advanced Blood Cancers Recruiting Loxo Oncology, Inc. Phase 1 2021-09-30 The purpose of this study is to find out whether the study drug, LOXO-338, is safe and effective in patients with advanced blood cancer. Patients must have already received standard therapy. The study may last up to approximately 3 years.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Pirtobrutinib

Condition Name

Condition Name for Pirtobrutinib
Intervention Trials
Healthy 9
Chronic Lymphocytic Leukemia 6
Small Lymphocytic Lymphoma 6
Lymphoma, Mantle-Cell 3
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Condition MeSH

Condition MeSH for Pirtobrutinib
Intervention Trials
Lymphoma 11
Leukemia, Lymphocytic, Chronic, B-Cell 9
Leukemia, Lymphoid 9
Leukemia 8
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Clinical Trial Locations for Pirtobrutinib

Trials by Country

Trials by Country for Pirtobrutinib
Location Trials
United States 64
Japan 18
China 18
United Kingdom 8
France 7
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Trials by US State

Trials by US State for Pirtobrutinib
Location Trials
Florida 11
Texas 8
California 4
Minnesota 3
Missouri 3
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Clinical Trial Progress for Pirtobrutinib

Clinical Trial Phase

Clinical Trial Phase for Pirtobrutinib
Clinical Trial Phase Trials
Phase 3 5
Phase 2 8
Phase 1 11
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Clinical Trial Status

Clinical Trial Status for Pirtobrutinib
Clinical Trial Phase Trials
Not yet recruiting 9
Completed 8
Recruiting 6
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Clinical Trial Sponsors for Pirtobrutinib

Sponsor Name

Sponsor Name for Pirtobrutinib
Sponsor Trials
Loxo Oncology, Inc. 17
Eli Lilly and Company 13
M.D. Anderson Cancer Center 3
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Sponsor Type

Sponsor Type for Pirtobrutinib
Sponsor Trials
Industry 30
Other 9
NIH 1
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Pirtobrutinib: A Comprehensive Update on Clinical Trials, Market Analysis, and Projections

Introduction to Pirtobrutinib

Pirtobrutinib, marketed as Jaypirca®, is a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor developed by Eli Lilly and Company. It has been gaining significant attention for its potential in treating various B-cell malignancies, particularly chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL).

Clinical Trials Update

BRUIN CLL-321 Phase 3 Trial

The BRUIN CLL-321 trial is a landmark study that has provided substantial evidence of pirtobrutinib's efficacy. This Phase 3 trial, presented at the 66th American Society of Hematology (ASH) Annual Meeting, focused on adult patients with CLL or SLL who had previously been treated with a covalent BTK inhibitor. Key findings include:

  • Progression-Free Survival (PFS): Pirtobrutinib reduced the risk of disease progression or death by 46% compared to idelalisib plus rituximab or bendamustine plus rituximab[1][4].
  • Time to Next Treatment or Death: Pirtobrutinib prolonged this period by a median of 23.9 months, significantly longer than the 10.9 months observed in the control arm[1][4].
  • Safety Profile: The treatment was associated with fewer grade 3 or higher treatment-emergent adverse events (TEAEs) and fewer treatment discontinuations due to adverse events compared to the control arm[1][4].

BRUIN Phase 1/2 Study

The BRUIN Phase 1/2 clinical trial evaluated pirtobrutinib in patients with CLL/SLL and MCL who had received multiple prior lines of therapy. The study highlighted:

  • Overall Response Rate (ORR): An ORR of 49.3% was observed in patients with CLL/SLL, indicating promising efficacy[3].
  • Tolerability and Efficacy: Longer follow-up data continued to support the tolerability and efficacy of pirtobrutinib, especially in the post-covalent BTK inhibitor setting[3].

Market Analysis

Market Size and Growth

The global pirtobrutinib market is projected to grow at a significant compound annual growth rate (CAGR) from 2024 to 2034. This growth is driven by several factors:

  • Increasing Incidence of Blood Malignancies: The rising incidence of CLL, SLL, and MCL, along with other hematologic malignancies, is a key driver[2].
  • Advances in Cancer Research: Novel medicines and targeted therapies are being developed, enhancing treatment options for these diseases[2].
  • Regulatory Approvals and Market Launch: The FDA's accelerated approval of pirtobrutinib has boosted its market presence[2].

Market Segmentation

The pirtobrutinib market is segmented by application, with CLL/SLL accounting for the largest share, approximately 45% in 2024. Other segments include MCL and other hematologic malignancies[2].

Regional Market Forecast

  • North America: This region dominates the market, driven by high prevalence rates of hematologic cancers, advanced healthcare infrastructure, and substantial investment in research and development[2].
  • Europe: Market growth in Europe is fueled by increasing adoption of targeted therapies and a rising incidence of CLL. Regulatory advancements and improved treatment options further drive demand[2].
  • Asia Pacific: Rapid growth is observed due to rising cancer rates and improving healthcare infrastructure. Increasing awareness of targeted therapies and investments in healthcare development drive demand in this region[2].

Market Projections

Future Outlook

The pirtobrutinib market is expected to expand significantly over the next decade, driven by several key factors:

  • Aging Population: The increasing susceptibility of the aging population to blood malignancies will drive the need for medications like pirtobrutinib[2].
  • Healthcare Spending and Infrastructure: Rising healthcare spending and improvements in healthcare infrastructure, especially in emerging nations, will support market growth[2].
  • Regulatory Environment: Strong pharmaceutical presence and favorable regulatory environments in regions like North America and Europe will enhance the adoption of pirtobrutinib[2].

Key Market Players

Eli Lilly and Company is the primary player in the pirtobrutinib market, with ongoing investigations and multiple clinical trials evaluating the drug's potential in various B-cell malignancies[1][3][4].

Safety and Efficacy

Adverse Events

Pirtobrutinib's safety profile has been consistent across studies, with fewer grade 3 or higher TEAEs and fewer treatment discontinuations due to adverse events compared to other treatments. However, the labeling includes warnings for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, and embryo-fetal toxicity[1][3].

Clinical Meaningful Outcomes

Pirtobrutinib has demonstrated clinically meaningful improvements in several secondary endpoints, including investigator-assessed PFS, event-free survival (EFS), and time to next treatment or death. These outcomes are particularly significant in the post-covalent BTK inhibitor setting, where treatment options are limited[1][4].

Key Takeaways

  • Efficacy in CLL/SLL: Pirtobrutinib has shown significant efficacy in reducing the risk of disease progression or death in patients with CLL/SLL previously treated with a covalent BTK inhibitor.
  • Market Growth: The global pirtobrutinib market is projected to grow substantially, driven by increasing incidence of blood malignancies and advances in cancer research.
  • Safety Profile: Pirtobrutinib has a favorable safety profile with fewer severe adverse events compared to other treatments.
  • Regulatory Approvals: FDA accelerated approvals have facilitated the market launch and acceptance of pirtobrutinib.

FAQs

What is pirtobrutinib, and how does it work?

Pirtobrutinib is a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor used to treat B-cell malignancies such as CLL, SLL, and MCL. It works by inhibiting the BTK enzyme, which is crucial for the survival and proliferation of B cells.

What are the key findings from the BRUIN CLL-321 trial?

The BRUIN CLL-321 trial showed that pirtobrutinib reduced the risk of disease progression or death by 46% and prolonged the time to next treatment or death by a median of 23.9 months compared to the control arm.

What is the market size and growth projection for pirtobrutinib?

The global pirtobrutinib market is projected to grow at a significant CAGR from 2024 to 2034, driven by increasing incidence of blood malignancies and advances in cancer research.

Which regions dominate the pirtobrutinib market?

North America dominates the market, followed by Europe and the Asia Pacific region, due to factors such as high prevalence rates, advanced healthcare infrastructure, and increasing awareness of targeted therapies.

What are the common adverse events associated with pirtobrutinib?

Common adverse events include infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, and embryo-fetal toxicity, although pirtobrutinib has a generally favorable safety profile compared to other treatments.

Sources

  1. PR Newswire: Phase 3 results for Lilly's Jaypirca® (pirtobrutinib) in covalent BTK inhibitor pre-treated chronic lymphocytic leukemia or small lymphocytic lymphoma to be presented at the 2024 ASH Annual Meeting[1].
  2. We Market Research: Pirtobrutinib Market Size, Share, Global Trends & Statistics[2].
  3. PR Newswire: Updated Data from the BRUIN Phase 1/2 Study of Pirtobrutinib in Chronic Lymphocytic Leukemia and Mantle Cell Lymphoma Presented at the 2023 ASH Annual Meeting[3].
  4. Eli Lilly and Company: Phase 3 results for Lilly's Jaypirca® (pirtobrutinib) in covalent BTK inhibitor pre-treated chronic lymphocytic leukemia or small lymphocytic lymphoma to be presented at the 2024 ASH Annual Meeting[4].

More… ↓

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