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Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR KEYTRUDA


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Biosimilar Clinical Trials for KEYTRUDA

This table shows clinical trials for biosimilars. See the next table for all clinical trials
Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT06153238 ↗ A PK Study to Compare GME751 (Proposed Pembrolizumab Biosimilar) and US-licensed and EU-authorized Keytruda® in Participants With Stage II and III Melanoma Recruiting Sandoz Phase 1 2024-05-15 The purpose of this study is to investigate the pharmacokinetic (PK) similarity and efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in subjects with resected advanced melanoma requiring adjuvant treatment with pembrolizumab.
NCT06159790 ↗ A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) Recruiting Sandoz Phase 3 2024-04-29 The purpose of this study is to investigate the efficacy, safety, and immunogenicity of GME751 compared with Keytruda® (pembrolizumab) in participants with untreated metastatic non-squamous NSCLC (irrespective of PD-L1 status), without sensitizing EGFR or ALK mutations.
NCT05668650 ↗ Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC Not yet recruiting Syneos Health Phase 3 2023-03-01 This is a randomized, multicenter, multinational, double-blind, and parallel-group study to evaluate the PK, efficacy, safety and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with newly diagnosed stage IV non-squamous NSCLC. This study is planned to be conducted in approximately 48 sites in 7 countries, a total of 174 subjects will be enrolled. Eligible subjects will be randomized in a 1:1 ratio to receive MB12 or Keytruda® at a dose of 200 mg every 3 weeks. Subjects will be stratified by gender (male versus female) and ECOG status (0 versus 1) as both factors are considered to have the potential to influence PK properties of pembrolizumab to some extent. The study will consist of 2 periods defined as follows: - Main Study Period from Screening up to Cycle 6 included. - Extended Treatment Period from Cycle 7 up to Week 52 for those subjects who demonstrate clinical benefit from the treatment (complete response [CR], partial response [PR], and stable disease [SD]). They will continue treatment until disease progression, intolerance to the study drug, treatment discontinuation for other reason, or up to Week 52, whichever occurs first. A Data Safety Monitoring Board (DSMB) will assess the safety data periodically and will recommend to the sponsor whether to continue, modify, or stop the trial on the basis of safety considerations. After the first 10 subjects have received at least 2 cycles of treatment, the DSMB will review the accumulated safety data, and the first meeting will take place. Subsequent meetings will be performed as per the DSMB charter.
NCT05668650 ↗ Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC Not yet recruiting Laboratorio Elea Phoenix S.A. Phase 3 2023-03-01 This is a randomized, multicenter, multinational, double-blind, and parallel-group study to evaluate the PK, efficacy, safety and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with newly diagnosed stage IV non-squamous NSCLC. This study is planned to be conducted in approximately 48 sites in 7 countries, a total of 174 subjects will be enrolled. Eligible subjects will be randomized in a 1:1 ratio to receive MB12 or Keytruda® at a dose of 200 mg every 3 weeks. Subjects will be stratified by gender (male versus female) and ECOG status (0 versus 1) as both factors are considered to have the potential to influence PK properties of pembrolizumab to some extent. The study will consist of 2 periods defined as follows: - Main Study Period from Screening up to Cycle 6 included. - Extended Treatment Period from Cycle 7 up to Week 52 for those subjects who demonstrate clinical benefit from the treatment (complete response [CR], partial response [PR], and stable disease [SD]). They will continue treatment until disease progression, intolerance to the study drug, treatment discontinuation for other reason, or up to Week 52, whichever occurs first. A Data Safety Monitoring Board (DSMB) will assess the safety data periodically and will recommend to the sponsor whether to continue, modify, or stop the trial on the basis of safety considerations. After the first 10 subjects have received at least 2 cycles of treatment, the DSMB will review the accumulated safety data, and the first meeting will take place. Subsequent meetings will be performed as per the DSMB charter.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

All Clinical Trials for KEYTRUDA

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01822652 ↗ 3rd Generation GD-2 Chimeric Antigen Receptor and iCaspase Suicide Safety Switch, Neuroblastoma, GRAIN Active, not recruiting Center for Cell and Gene Therapy, Baylor College of Medicine Phase 1 2013-08-01 Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene transfer research study. We have found from previous research that we can put a new gene called a chimeric antigen receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill them. In a previous clinical trial, we used a CAR that recognizes GD2, a protein found on almost all neuroblastoma cells (GD2-CAR). We put this gene into T cells and gave them back to patients that had neuroblastoma. The infusions were safe and in patients with disease at the time of their infusion, the time to progression was longer if we could find GD2 T cells in their blood for more than 6 weeks. Because of this, we think that if T cells are able to last longer, they may have a better chance of killing neuroblastoma tumor cells. Therefore, in this study we will add new genes to the GD2 T cells that can cause the cells to live longer. These new genes are called CD28 and OX40. The purpose of this study will be to determine the highest dose of iC9-GD2-CD28-OX40 (iC9-GD2) T cells that can safely be given to patients with relapsed/refractory neuroblastoma. In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and we think that it will allow the T cells we infuse to expand and stay longer in the body, and potentially kill cancer cells more effectively. The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and fludarabine. Additionally, to effectively kill the tumor cells, it is important that the T cells are able to survive and expand in the tumor. Recent studies have shown that solid tumors release a substance (PD1) that can inhibit T cells after they arrive into the tumor tissue. In an attempt to overcome the effect of PD1 in neuroblastoma we will also give a medication called pembrolizumab.
NCT01822652 ↗ 3rd Generation GD-2 Chimeric Antigen Receptor and iCaspase Suicide Safety Switch, Neuroblastoma, GRAIN Active, not recruiting Kids Cancer Research Foundation Phase 1 2013-08-01 Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene transfer research study. We have found from previous research that we can put a new gene called a chimeric antigen receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill them. In a previous clinical trial, we used a CAR that recognizes GD2, a protein found on almost all neuroblastoma cells (GD2-CAR). We put this gene into T cells and gave them back to patients that had neuroblastoma. The infusions were safe and in patients with disease at the time of their infusion, the time to progression was longer if we could find GD2 T cells in their blood for more than 6 weeks. Because of this, we think that if T cells are able to last longer, they may have a better chance of killing neuroblastoma tumor cells. Therefore, in this study we will add new genes to the GD2 T cells that can cause the cells to live longer. These new genes are called CD28 and OX40. The purpose of this study will be to determine the highest dose of iC9-GD2-CD28-OX40 (iC9-GD2) T cells that can safely be given to patients with relapsed/refractory neuroblastoma. In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and we think that it will allow the T cells we infuse to expand and stay longer in the body, and potentially kill cancer cells more effectively. The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and fludarabine. Additionally, to effectively kill the tumor cells, it is important that the T cells are able to survive and expand in the tumor. Recent studies have shown that solid tumors release a substance (PD1) that can inhibit T cells after they arrive into the tumor tissue. In an attempt to overcome the effect of PD1 in neuroblastoma we will also give a medication called pembrolizumab.
NCT01822652 ↗ 3rd Generation GD-2 Chimeric Antigen Receptor and iCaspase Suicide Safety Switch, Neuroblastoma, GRAIN Active, not recruiting Kids' Cancer Research Foundation Phase 1 2013-08-01 Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene transfer research study. We have found from previous research that we can put a new gene called a chimeric antigen receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill them. In a previous clinical trial, we used a CAR that recognizes GD2, a protein found on almost all neuroblastoma cells (GD2-CAR). We put this gene into T cells and gave them back to patients that had neuroblastoma. The infusions were safe and in patients with disease at the time of their infusion, the time to progression was longer if we could find GD2 T cells in their blood for more than 6 weeks. Because of this, we think that if T cells are able to last longer, they may have a better chance of killing neuroblastoma tumor cells. Therefore, in this study we will add new genes to the GD2 T cells that can cause the cells to live longer. These new genes are called CD28 and OX40. The purpose of this study will be to determine the highest dose of iC9-GD2-CD28-OX40 (iC9-GD2) T cells that can safely be given to patients with relapsed/refractory neuroblastoma. In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and we think that it will allow the T cells we infuse to expand and stay longer in the body, and potentially kill cancer cells more effectively. The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and fludarabine. Additionally, to effectively kill the tumor cells, it is important that the T cells are able to survive and expand in the tumor. Recent studies have shown that solid tumors release a substance (PD1) that can inhibit T cells after they arrive into the tumor tissue. In an attempt to overcome the effect of PD1 in neuroblastoma we will also give a medication called pembrolizumab.
NCT01822652 ↗ 3rd Generation GD-2 Chimeric Antigen Receptor and iCaspase Suicide Safety Switch, Neuroblastoma, GRAIN Active, not recruiting National Cancer Institute (NCI) Phase 1 2013-08-01 Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene transfer research study. We have found from previous research that we can put a new gene called a chimeric antigen receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill them. In a previous clinical trial, we used a CAR that recognizes GD2, a protein found on almost all neuroblastoma cells (GD2-CAR). We put this gene into T cells and gave them back to patients that had neuroblastoma. The infusions were safe and in patients with disease at the time of their infusion, the time to progression was longer if we could find GD2 T cells in their blood for more than 6 weeks. Because of this, we think that if T cells are able to last longer, they may have a better chance of killing neuroblastoma tumor cells. Therefore, in this study we will add new genes to the GD2 T cells that can cause the cells to live longer. These new genes are called CD28 and OX40. The purpose of this study will be to determine the highest dose of iC9-GD2-CD28-OX40 (iC9-GD2) T cells that can safely be given to patients with relapsed/refractory neuroblastoma. In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and we think that it will allow the T cells we infuse to expand and stay longer in the body, and potentially kill cancer cells more effectively. The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and fludarabine. Additionally, to effectively kill the tumor cells, it is important that the T cells are able to survive and expand in the tumor. Recent studies have shown that solid tumors release a substance (PD1) that can inhibit T cells after they arrive into the tumor tissue. In an attempt to overcome the effect of PD1 in neuroblastoma we will also give a medication called pembrolizumab.
NCT01822652 ↗ 3rd Generation GD-2 Chimeric Antigen Receptor and iCaspase Suicide Safety Switch, Neuroblastoma, GRAIN Active, not recruiting Solving Kids' Cancer Phase 1 2013-08-01 Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene transfer research study. We have found from previous research that we can put a new gene called a chimeric antigen receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill them. In a previous clinical trial, we used a CAR that recognizes GD2, a protein found on almost all neuroblastoma cells (GD2-CAR). We put this gene into T cells and gave them back to patients that had neuroblastoma. The infusions were safe and in patients with disease at the time of their infusion, the time to progression was longer if we could find GD2 T cells in their blood for more than 6 weeks. Because of this, we think that if T cells are able to last longer, they may have a better chance of killing neuroblastoma tumor cells. Therefore, in this study we will add new genes to the GD2 T cells that can cause the cells to live longer. These new genes are called CD28 and OX40. The purpose of this study will be to determine the highest dose of iC9-GD2-CD28-OX40 (iC9-GD2) T cells that can safely be given to patients with relapsed/refractory neuroblastoma. In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and we think that it will allow the T cells we infuse to expand and stay longer in the body, and potentially kill cancer cells more effectively. The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and fludarabine. Additionally, to effectively kill the tumor cells, it is important that the T cells are able to survive and expand in the tumor. Recent studies have shown that solid tumors release a substance (PD1) that can inhibit T cells after they arrive into the tumor tissue. In an attempt to overcome the effect of PD1 in neuroblastoma we will also give a medication called pembrolizumab.
NCT01822652 ↗ 3rd Generation GD-2 Chimeric Antigen Receptor and iCaspase Suicide Safety Switch, Neuroblastoma, GRAIN Active, not recruiting Solving Kids’ Cancer Phase 1 2013-08-01 Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene transfer research study. We have found from previous research that we can put a new gene called a chimeric antigen receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill them. In a previous clinical trial, we used a CAR that recognizes GD2, a protein found on almost all neuroblastoma cells (GD2-CAR). We put this gene into T cells and gave them back to patients that had neuroblastoma. The infusions were safe and in patients with disease at the time of their infusion, the time to progression was longer if we could find GD2 T cells in their blood for more than 6 weeks. Because of this, we think that if T cells are able to last longer, they may have a better chance of killing neuroblastoma tumor cells. Therefore, in this study we will add new genes to the GD2 T cells that can cause the cells to live longer. These new genes are called CD28 and OX40. The purpose of this study will be to determine the highest dose of iC9-GD2-CD28-OX40 (iC9-GD2) T cells that can safely be given to patients with relapsed/refractory neuroblastoma. In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and we think that it will allow the T cells we infuse to expand and stay longer in the body, and potentially kill cancer cells more effectively. The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and fludarabine. Additionally, to effectively kill the tumor cells, it is important that the T cells are able to survive and expand in the tumor. Recent studies have shown that solid tumors release a substance (PD1) that can inhibit T cells after they arrive into the tumor tissue. In an attempt to overcome the effect of PD1 in neuroblastoma we will also give a medication called pembrolizumab.
NCT01822652 ↗ 3rd Generation GD-2 Chimeric Antigen Receptor and iCaspase Suicide Safety Switch, Neuroblastoma, GRAIN Active, not recruiting Texas Children's Hospital Phase 1 2013-08-01 Subjects that have relapsed or refractory neuroblastoma are invited to take part in this gene transfer research study. We have found from previous research that we can put a new gene called a chimeric antigen receptor (CAR) into T cells that will make them recognize neuroblastoma cells and kill them. In a previous clinical trial, we used a CAR that recognizes GD2, a protein found on almost all neuroblastoma cells (GD2-CAR). We put this gene into T cells and gave them back to patients that had neuroblastoma. The infusions were safe and in patients with disease at the time of their infusion, the time to progression was longer if we could find GD2 T cells in their blood for more than 6 weeks. Because of this, we think that if T cells are able to last longer, they may have a better chance of killing neuroblastoma tumor cells. Therefore, in this study we will add new genes to the GD2 T cells that can cause the cells to live longer. These new genes are called CD28 and OX40. The purpose of this study will be to determine the highest dose of iC9-GD2-CD28-OX40 (iC9-GD2) T cells that can safely be given to patients with relapsed/refractory neuroblastoma. In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. This is called lymphodepletion and we think that it will allow the T cells we infuse to expand and stay longer in the body, and potentially kill cancer cells more effectively. The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and fludarabine. Additionally, to effectively kill the tumor cells, it is important that the T cells are able to survive and expand in the tumor. Recent studies have shown that solid tumors release a substance (PD1) that can inhibit T cells after they arrive into the tumor tissue. In an attempt to overcome the effect of PD1 in neuroblastoma we will also give a medication called pembrolizumab.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for KEYTRUDA

Condition Name

48373634005101520253035404550MelanomaNon-Small Cell Lung CancerBreast CancerHead and Neck Squamous Cell Carcinoma[disabled in preview]
Condition Name for KEYTRUDA
Intervention Trials
Melanoma 48
Non-Small Cell Lung Cancer 37
Breast Cancer 36
Head and Neck Squamous Cell Carcinoma 34
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Condition MeSH

19310996880020406080100120140160180200CarcinomaCarcinoma, Non-Small-Cell LungLung NeoplasmsCarcinoma, Squamous Cell[disabled in preview]
Condition MeSH for KEYTRUDA
Intervention Trials
Carcinoma 193
Carcinoma, Non-Small-Cell Lung 109
Lung Neoplasms 96
Carcinoma, Squamous Cell 88
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Clinical Trial Locations for KEYTRUDA

Trials by Country

+
Trials by Country for KEYTRUDA
Location Trials
China 80
Spain 78
Canada 71
Australia 71
United Kingdom 54
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Trials by US State

+
Trials by US State for KEYTRUDA
Location Trials
California 176
Texas 157
New York 102
Massachusetts 96
Illinois 92
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Clinical Trial Progress for KEYTRUDA

Clinical Trial Phase

94.4%00100200300400500600700Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for KEYTRUDA
Clinical Trial Phase Trials
Phase 4 2
Phase 3 30
Phase 2/Phase 3 8
[disabled in preview] 677
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Clinical Trial Status

42.6%21.0%19.8%16.6%0120140160180200220240260280300320RecruitingNot yet recruitingActive, not recruiting[disabled in preview]
Clinical Trial Status for KEYTRUDA
Clinical Trial Phase Trials
Recruiting 306
Not yet recruiting 151
Active, not recruiting 142
[disabled in preview] 119
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Clinical Trial Sponsors for KEYTRUDA

Sponsor Name

trials050100150200250300Merck Sharp & Dohme Corp.National Cancer Institute (NCI)M.D. Anderson Cancer Center[disabled in preview]
Sponsor Name for KEYTRUDA
Sponsor Trials
Merck Sharp & Dohme Corp. 307
National Cancer Institute (NCI) 142
M.D. Anderson Cancer Center 45
[disabled in preview] 89
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Sponsor Type

46.8%43.8%8.9%00100200300400500600700800OtherIndustryNIH[disabled in preview]
Sponsor Type for KEYTRUDA
Sponsor Trials
Other 749
Industry 701
NIH 143
[disabled in preview] 8
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KEYTRUDA: Clinical Trials Update, Market Analysis, and Projections

Introduction to KEYTRUDA

KEYTRUDA (pembrolizumab) is a groundbreaking immunotherapy drug developed by Merck & Co., Inc., targeting the programmed death-1 (PD-1) receptor. It has revolutionized the treatment of various types of cancer by enhancing the body's immune response against cancer cells.

Clinical Trials Update

KEYNOTE-867 Trial

Merck recently announced the discontinuation of the Phase 3 KEYNOTE-867 trial, which evaluated KEYTRUDA in combination with stereotactic body radiotherapy (SBRT) for the treatment of patients with stage I or II non-small cell lung cancer (NSCLC), including those who are medically inoperable or have refused surgery. The decision was based on the recommendation of an independent Data Monitoring Committee (DMC) after a pre-specified interim analysis showed that KEYTRUDA plus SBRT did not improve event-free survival (EFS) or overall survival (OS) compared to placebo plus SBRT. The benefit/risk profile of the combination did not support continuing the trial[1].

KEYNOTE-630 Trial

Another Phase 3 trial, KEYNOTE-630, was also discontinued. This trial assessed KEYTRUDA as adjuvant therapy in patients with high-risk locally advanced cutaneous squamous cell carcinoma (cSCC) following surgery and radiation. The DMC recommended stopping the trial due to futility, as KEYTRUDA did not demonstrate statistical significance in recurrence-free survival (RFS), the primary endpoint. The overall survival (OS) endpoint was not formally tested, but the results did not favor KEYTRUDA over placebo[1].

Clinical Efficacy of KEYTRUDA

Despite the setbacks in the KEYNOTE-867 and KEYNOTE-630 trials, KEYTRUDA has shown significant clinical efficacy in various other cancer types. For instance, in advanced non-small cell lung cancer, KEYTRUDA reduced the risk of disease progression by 50% compared to chemotherapy. In a clinical trial, 41% of patients treated with KEYTRUDA had tumors shrink, and 4% had complete responses, compared to 27% and 1%, respectively, for those receiving chemotherapy. Additionally, patients on KEYTRUDA had a longer period without cancer progression, with half of the patients alive without disease progression at 10.3 months, compared to 6 months for those on chemotherapy[4].

Market Analysis

Current Market Size

The KEYTRUDA market has experienced robust growth, driven by improved patient outcomes, increased adoption of immunotherapy, and expanded indications. As of 2024, the KEYTRUDA market size is estimated to be around $27.80 billion[5].

Growth Projections

The market is projected to continue its strong growth trajectory. By 2028, the KEYTRUDA market is expected to reach $31.52 billion at a compound annual growth rate (CAGR) of 9.9%[2]. Another forecast suggests that the market will reach $32.10 billion by 2029, growing at a CAGR of 2.94% from 2024 to 2029[5].

Regional Market Performance

North America currently holds the largest market share for KEYTRUDA, while the Asia Pacific region is expected to be the fastest-growing market over the forecast period. This growth is attributed to increasing cancer incidences, rising healthcare expenditures, and greater access to advanced treatments in these regions[5].

Competitive Landscape

KEYTRUDA faces competition from other checkpoint inhibitors such as Opdivo (nivolumab) and Tecentriq (atezolizumab). Despite this competition, KEYTRUDA remains a leading drug in the immunotherapy market, influencing pricing and market share dynamics[3].

Key Factors Driving Market Growth

Rising Adoption of Immunotherapy

The increasing adoption of immunotherapy as a treatment option for various cancers has significantly contributed to the growth of the KEYTRUDA market. Immunotherapy has shown promising results in improving patient outcomes, leading to higher demand for drugs like KEYTRUDA[5].

Expanded Indications

KEYTRUDA has received approvals for multiple indications over the years, expanding its market potential. Continuous evaluation in clinical trials for additional cancer types and stages has helped broaden its use[3].

Regulatory Approvals

Regulatory approvals for diverse indications have been a crucial factor in the growth of the KEYTRUDA market. These approvals have validated the drug's efficacy and safety, further enhancing its market position[5].

Challenges and Future Directions

Clinical Trial Outcomes

The discontinuation of trials like KEYNOTE-867 and KEYNOTE-630 highlights the challenges in clinical research. Despite these setbacks, Merck continues to invest in research and development to explore new indications and combinations for KEYTRUDA[1].

Competitive Pressures

The immunotherapy market is highly competitive, with several other checkpoint inhibitors vying for market share. KEYTRUDA must continue to demonstrate superior efficacy and safety to maintain its market leadership[3].

Key Takeaways

  • Clinical Trials: KEYTRUDA trials like KEYNOTE-867 and KEYNOTE-630 were discontinued due to lack of efficacy in specific indications.
  • Clinical Efficacy: KEYTRUDA has shown significant clinical benefits in various cancer types, particularly in advanced NSCLC.
  • Market Size and Growth: The KEYTRUDA market is projected to reach $31.52 billion by 2028, growing at a CAGR of 9.9%.
  • Regional Performance: North America is the largest market, while the Asia Pacific region is the fastest-growing.
  • Competitive Landscape: KEYTRUDA faces competition from other checkpoint inhibitors but remains a market leader.

FAQs

What is the current market size of KEYTRUDA?

The KEYTRUDA market size is estimated to be around $27.80 billion in 2024[5].

What is the projected growth rate of the KEYTRUDA market?

The KEYTRUDA market is expected to grow at a CAGR of 9.9% to reach $31.52 billion by 2028[2].

Which region has the largest market share for KEYTRUDA?

North America currently holds the largest market share for KEYTRUDA[5].

What are the key factors driving the growth of the KEYTRUDA market?

Key factors include the rising adoption of immunotherapy, expanded indications, and regulatory approvals for diverse indications[5].

How does KEYTRUDA compare to other checkpoint inhibitors?

KEYTRUDA faces competition from drugs like Opdivo and Tecentriq but remains a leading drug in the immunotherapy market due to its clinical efficacy and broad indications[3].

Sources

  1. Merck Provides Update on Phase 3 KEYNOTE-867 and KEYNOTE-630 Trials - Merck News.
  2. Keytruda Global Market 2024 To Reach $31.52 Billion By 2028 At Rate Of 9.9% - EIN Presswire.
  3. Latest Global Keytruda Market Size, Forecast, Analysis & Share - EIN Presswire.
  4. Monotherapy Clinical Trial Results for Advanced Non–Small Cell Lung Cancer - Keytruda.com.
  5. Keytruda Market Size & Share Analysis - Industry Research Report - Mordor Intelligence.

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