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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR KYPROLIS


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505(b)(2) Clinical Trials for Kyprolis

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial TypeTrial IDTitleStatusSponsorPhaseStart DateSummary
New Combination NCT02188368 ↗ Pomalidomide for Lenalidomide for Relapsed or Refractory Multiple Myeloma Patients Active, not recruiting Celgene Corporation Phase 2 2014-08-01 The purpose of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of pomalidomide given as part of a combination therapy that include more than just steroids to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not respond to past treatment) multiple myeloma (MM). Pomalidomide (alone or in combination with dexamethasone) has been approved by the United States Food and Drug Administration (FDA) for the treatment of MM patients who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of their last therapy. However, the use of pomalidomide in combination with other drugs used to treat MM, such as chemotherapeutic agents and proteasome inhibitors, is currently being tested and is not approved. Pomalidomide is in the same drug class as thalidomide and lenalidomide. Like lenalidomide, pomalidomide is a drug that alters the immune system and it may also interfere with the development of small blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. The testing done with pomalidomide thus far has shown that it is well-tolerated and effective for subjects with MM both on its own and in combination with dexamethasone. Using another drug class, namely proteasome inhibitors, we have demonstrated that simply replacing a proteasome inhibitor with another in an established anti-myeloma treatment regimen can frequently overcome resistance regardless of the other agents that are part of the anti-myeloma regimen. Importantly, the toxicity profile of the new combinations closely resembled that of the proteasome inhibitor administered as a single agent. Based on this experience, we hypothesize that the replacement of lenalidomide with pomalidomide will yield similar results in a similar relapsed/refractory MM patient population.
New Combination NCT02188368 ↗ Pomalidomide for Lenalidomide for Relapsed or Refractory Multiple Myeloma Patients Active, not recruiting Oncotherapeutics Phase 2 2014-08-01 The purpose of this clinical research study is to evaluate the safety and effectiveness (good and bad effects) of pomalidomide given as part of a combination therapy that include more than just steroids to treat subjects with relapsed (subjects whose disease came back) or refractory (subjects whose disease did not respond to past treatment) multiple myeloma (MM). Pomalidomide (alone or in combination with dexamethasone) has been approved by the United States Food and Drug Administration (FDA) for the treatment of MM patients who have received at least two prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of their last therapy. However, the use of pomalidomide in combination with other drugs used to treat MM, such as chemotherapeutic agents and proteasome inhibitors, is currently being tested and is not approved. Pomalidomide is in the same drug class as thalidomide and lenalidomide. Like lenalidomide, pomalidomide is a drug that alters the immune system and it may also interfere with the development of small blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. The testing done with pomalidomide thus far has shown that it is well-tolerated and effective for subjects with MM both on its own and in combination with dexamethasone. Using another drug class, namely proteasome inhibitors, we have demonstrated that simply replacing a proteasome inhibitor with another in an established anti-myeloma treatment regimen can frequently overcome resistance regardless of the other agents that are part of the anti-myeloma regimen. Importantly, the toxicity profile of the new combinations closely resembled that of the proteasome inhibitor administered as a single agent. Based on this experience, we hypothesize that the replacement of lenalidomide with pomalidomide will yield similar results in a similar relapsed/refractory MM patient population.
>Trial Type>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 2 of 2 entries

All Clinical Trials for Kyprolis

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00461045 ↗ Phase 2 Clinical Trial of NPI-0052 in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma Completed Celgene Phase 2 2007-03-01 This is a Phase 2, open-label, multicenter study examining the safety, pharmacokinetics and pharmacodynamics, and best overall response to escalating doses of the proteasome inhibitor NPI-0052 (also known as marizomib) in patients with relapsed or relapsed/refractory multiple myeloma. NPI-0052 is a novel, second generation proteasome inhibitor that prevents the breakdown of proteins involved in signal transduction which blocks growth and survival in cancer cells. The study is a Phase 2 study and is a 2-stage efficacy design in a selected subgroup of patients (Arm C) treated with the recommended phase 2 dose of NPI-0052, as determined in a previously completed Phase 1 study. The study is to evaluate the safety and any preliminary evidence of efficacy of NPI-0052 in multiple myeloma patients who have previously received carfilzomib (PR-171, Kyprolis™) and subsequently had disease progression.
NCT00150462 ↗ Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies Completed Amgen Phase 1 2005-09-01 The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's macroglobulinemia. Carfilzomib is a proteasome inhibitor, an enzyme responsible for degrading a wide variety of cellular proteins.
NCT00150462 ↗ Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies Completed Onyx Pharmaceuticals Phase 1 2005-09-01 The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's macroglobulinemia. Carfilzomib is a proteasome inhibitor, an enzyme responsible for degrading a wide variety of cellular proteins.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for Kyprolis

Condition Name

4214130051015202530354045Multiple MyelomaRecurrent Plasma Cell MyelomaRefractory Plasma Cell Myeloma[disabled in preview]
Condition Name for Kyprolis
Intervention Trials
Multiple Myeloma 42
Recurrent Plasma Cell Myeloma 14
Refractory Plasma Cell Myeloma 13
[disabled in preview] 0
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Condition MeSH

747312001020304050607080Multiple MyelomaNeoplasms, Plasma CellLymphoma[disabled in preview]
Condition MeSH for Kyprolis
Intervention Trials
Multiple Myeloma 74
Neoplasms, Plasma Cell 73
Lymphoma 12
[disabled in preview] 0
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Clinical Trial Locations for Kyprolis

Trials by Country

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Trials by Country for Kyprolis
Location Trials
United States 340
China 29
India 16
United Kingdom 15
Spain 9
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Trials by US State

+
Trials by US State for Kyprolis
Location Trials
Illinois 22
California 21
New York 18
Texas 17
Ohio 15
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Clinical Trial Progress for Kyprolis

Clinical Trial Phase

13.7%84.3%0051015202530354045Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for Kyprolis
Clinical Trial Phase Trials
Phase 4 1
Phase 3 7
Phase 2 43
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Clinical Trial Status

43.7%35.2%21.1%0051015202530RecruitingCompletedActive, not recruiting[disabled in preview]
Clinical Trial Status for Kyprolis
Clinical Trial Phase Trials
Recruiting 31
Completed 25
Active, not recruiting 15
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Clinical Trial Sponsors for Kyprolis

Sponsor Name

trials051015202530AmgenNational Cancer Institute (NCI)Onyx Therapeutics, Inc.[disabled in preview]
Sponsor Name for Kyprolis
Sponsor Trials
Amgen 31
National Cancer Institute (NCI) 26
Onyx Therapeutics, Inc. 11
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Sponsor Type

45.7%42.6%11.7%0-100102030405060708090100110IndustryOtherNIH[disabled in preview]
Sponsor Type for Kyprolis
Sponsor Trials
Industry 102
Other 95
NIH 26
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Kyprolis (Carfilzomib): Clinical Trials, Market Analysis, and Projections

Introduction to Kyprolis

Kyprolis, or carfilzomib, is a second-generation proteasome inhibitor developed by Amgen, designed to treat multiple myeloma, a type of blood cancer that affects plasma cells. Here, we will delve into the clinical trials, market analysis, and future projections for this significant drug.

Clinical Trials and Efficacy

ASPIRE and ENDEAVOR Trials

The ASPIRE and ENDEAVOR trials are two pivotal Phase 3 studies that have significantly impacted the clinical profile of Kyprolis. The ASPIRE trial demonstrated that the combination of Kyprolis, lenalidomide, and dexamethasone (KRd) reduced the risk of death by 21% compared to lenalidomide and dexamethasone alone (Rd), extending overall survival (OS) by 7.9 months (median OS 48.3 months for KRd versus 40.4 months for Rd)[1][4].

Similarly, the ENDEAVOR trial showed that Kyprolis in combination with dexamethasone (Kd) was superior to bortezomib and dexamethasone (Vd), with patients treated with Kyprolis living 7.6 months longer than those treated with bortezomib (median OS 47.6 months for Kd versus 40.0 months for Vd)[4].

Additional Clinical Findings

Kyprolis has also been studied in various other combinations and patient populations. For instance, a recent clinical trial by the Multiple Myeloma Research Consortium found that a single dose of carfilzomib was effective in patients who had received at least two prior therapies, including bortezomib and thalidomide, without exacerbating basal neuropathy[3].

Moreover, the combination of carfilzomib with daratumumab and dexamethasone (DKd) has been approved by the U.S. FDA for treating patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy[3].

Market Analysis

Current Market Size and Growth

The global Kyprolis market was valued at a significant amount in 2020 and is projected to grow at a substantial CAGR until 2030. This growth is driven by the increasing prevalence of blood cancers, improved efficacy of carfilzomib over traditional treatments, and reduced adverse reactions compared to other proteasome inhibitors[3].

Regional Market Dynamics

North America holds the largest share of the Kyprolis market, primarily due to the high prevalence of blood and bone marrow cancers in the region. However, the Asia-Pacific region is expected to show steady growth due to rising awareness about cancer treatments, increasing disposable income, and a growing demand for advanced drugs[3].

Competitive Landscape

The proteasome inhibitors market, which includes Kyprolis, is competitive with other drugs like Velcade (bortezomib) and Ninlaro (ixazomib). Despite Velcade's dominant market share, Kyprolis is expected to register a CAGR of over 10% from 2019 to 2023 due to its superior efficacy and target affinity[5].

Market Projections

Future Growth Opportunities

The Kyprolis market is anticipated to expand significantly in the coming years. Several factors contribute to this growth:

  • Increasing Prevalence of Blood Cancers: Globally, around 720,000 people die from blood cancer every year, creating a large patient pool for Kyprolis[3].
  • Advantages Over Traditional Treatments: Carfilzomib offers improved efficacy, reduced adverse reactions, and a lower risk of heart failure and dyspnea compared to other proteasome inhibitors[3].
  • Expanding Treatment Options: Ongoing research aims to use carfilzomib in treating solid tumors, which could further boost market growth[3].

Challenges and Limitations

Despite the promising outlook, there are challenges that could restrain market growth:

  • High Administration Costs: The cost of administering Kyprolis can be prohibitive for some patients, limiting its accessibility[3].
  • Lack of Awareness: Limited awareness about advanced cancer treatments among the general public can slow market adoption[3].

Regulatory Updates and Approvals

Recent Approvals

In recent years, Kyprolis has received several regulatory approvals that have expanded its use. For example, the U.S. FDA approved the combination of Kyprolis with daratumumab and dexamethasone (DKd) for treating relapsed or refractory multiple myeloma patients who have received one to three prior lines of therapy[3].

Ongoing Regulatory Processes

Amgen is also pursuing a long-acting formulation of Kyprolis, which is under review by the FDA through the Real-Time Oncology Review pilot program. This program aims to expedite the approval process for safe and effective treatments[2].

Key Takeaways

  • Clinical Efficacy: Kyprolis has demonstrated significant improvements in overall survival in multiple Phase 3 trials, making it a preferred treatment option for relapsed or refractory multiple myeloma.
  • Market Growth: The Kyprolis market is expected to grow substantially due to the increasing prevalence of blood cancers and the drug's superior efficacy.
  • Regional Dynamics: North America currently dominates the market, but the Asia-Pacific region is expected to show significant growth.
  • Regulatory Approvals: Recent and ongoing regulatory approvals are expanding the treatment options and patient populations for Kyprolis.

FAQs

What is Kyprolis used for?

Kyprolis (carfilzomib) is used to treat patients with relapsed or refractory multiple myeloma, a type of blood cancer that affects plasma cells.

How does Kyprolis work?

Kyprolis is a second-generation proteasome inhibitor that irreversibly binds to the threonine-containing active site of the 20S proteasome, inhibiting the growth and spread of cancer cells.

What are the key clinical trials for Kyprolis?

The ASPIRE and ENDEAVOR trials are two pivotal Phase 3 studies that have demonstrated Kyprolis's efficacy in improving overall survival in patients with relapsed multiple myeloma.

What are the market projections for Kyprolis?

The Kyprolis market is projected to grow significantly until 2030, driven by the increasing prevalence of blood cancers and the drug's superior efficacy.

What are the challenges facing the Kyprolis market?

High administration costs and a lack of awareness about advanced cancer treatments are among the challenges that could restrain market growth.

Sources

  1. Amgen Receives Positive CHMP Opinion To Add Overall Survival Results From The Phase 3 ASPIRE Study To KYPROLIS (Carfilzomib) Label. Amgen.
  2. Can Amgen's new-and-improved Kyprolis kick-start myeloma sales?. FiercePharma.
  3. Kyprolis (Carfilzomib) Market Size and Share | Analysis - 2030. Next MSC.
  4. Second Phase 3 Study Shows KYPROLIS® (Carfilzomib) Regimen Significantly Improves Overall Survival In Patients With Relapsed Multiple Myeloma. Amgen.
  5. Proteasome Inhibitors Market Size Worth $1.7 Billion by 2023. BioSpace.

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