Cancer immunotherapy has demonstrated significant clinical activity in different cancers. T cells represent a crucial component of the adaptive immune system and are thought to mediate anti-tumoral immunity. Antigen-specific recognition by T cells is via the T cell receptor (TCR) which is unique for each T cell. Next generation sequencing (NGS) of the TCRs can be used as a platform to profile the T cell repertoire. Though there are a number of software tools available for processing repertoire data by mapping antigen receptor segments to sequencing reads and assembling the clonotypes, most of them are not designed to track and examine the dynamic nature of the TCR repertoire across multiple time points or between different biologic compartments (e.g., blood and tissue samples) in a clinical context.

RESULTS:

We integrated different diversity measures to assess the T cell repertoire diversity and examined the robustness of the diversity indices. Among those tested, Clonality was identified for its robustness as a key metric for study design and the first choice to measure TCR repertoire diversity. To evaluate the dynamic nature of T cell clonotypes across time, we utilized several binary similarity measures (such as Baroni-Urbani and Buser overlap index), relative clonality and Morisita's overlap index, as well as the intraclass correlation coefficient, and performed fold change analysis, which was further extended to investigate the transition of clonotypes among different biological compartments. Furthermore, the application of differential testing enabled the detection of clonotypes which were significantly changed across time. By applying the proposed "3D" analysis pipeline to the real example of prostate cancer subjects who received sipuleucel-T, an FDA-approved immunotherapy, we were able to detect changes in TCR sequence frequency and diversity thus demonstrating that sipuleucel-T treatment affected TCR repertoire in blood and in prostate tissue. We also found that the increase in common TCR sequences between tissue and blood after sipuleucel-T treatment supported the hypothesis that treatment-induced T cell migrated into the prostate tissue. In addition, a second example of prostate cancer subjects treated with Ipilimumab and granulocyte macrophage colony stimulating factor (GM-CSF) was presented in the supplementary documents to further illustrate assessing the treatment-associated change in a clinical context by the proposed workflow.

CONCLUSIONS:

Our paper provides guidance to study the diversity and dynamics of NGS-based TCR repertoire profiling in a clinical context to ensure consistency and reproducibility of post-analysis. This analysis pipeline will provide an initial workflow for TCR sequencing data with serial time points and for comparing T cells in multiple compartments for a clinical study.

2017-05-15·Clinical cancer research : an official journal of the American Association for Cancer Research1区 · 医学

Sequencing of Sipuleucel-T and Androgen Deprivation Therapy in Men with Hormone-Sensitive Biochemically Recurrent Prostate Cancer: A Phase II Randomized Trial

1区 · 医学

Article

作者: DeVries, Todd ; Drake, Charles G. ; Yu, Evan Y. ; Shore, Neal D. ; Sheikh, Nadeem A. ; Chang, Nancy N. ; Elfiky, Aymen ; Corman, John M. ; Maher, Johnathan C. ; Millard, Frederick E. ; Vogelzang, Nicholas J. ; Antonarakis, Emmanuel S. ; Karsh, Lawrence I. ; Kibel, Adam S.

Abstract:

Purpose: STAND, a randomized, phase II, open-label trial (NCT01431391), assessed sequencing of sipuleucel-T (an autologous cellular immunotherapy) with androgen deprivation therapy (ADT) in biochemically recurrent prostate cancer (BRPC) patients at high risk for metastasis.Experimental Design: Men with BRPC following prostatectomy and/or radiotherapy, a PSA doubling time ≤12 months, and no metastasis were enrolled. Patients were randomized (34/arm) to sipuleucel-T followed by ADT (started 2 weeks after sipuleucel-T completion), or ADT followed by sipuleucel-T (started 12 weeks after ADT initiation); ADT continued for 12 months in both arms. The primary endpoint was PA2024-specific T-cell response [enzyme-linked immunospot (ELISPOT)] over time.Results: PA2024-specific ELISPOT responses over time were similar between groups, except at week 6, where responses were higher with sipuleucel-T→ADT versus ADT→sipuleucel-T (P = 0.013). PA2024-specific T-cell proliferation responses, averaged across time points, were approximately 2-fold higher with sipuleucel-T→ADT versus ADT→sipuleucel-T (P = 0.001). PA2024-specific cellular and humoral responses and prostatic acid phosphatase–specific humoral responses increased significantly versus baseline (P < 0.001) and were maintained for 24 months (both arms). Median time-to-PSA recurrence was similar between arms (21.8 vs. 22.6 months, P = 0.357). Development of a PA2024-specific humoral response correlated with prolonged time-to-PSA progression (HR, 0.22; 95% CI, 0.08–0.67; P = 0.007). Sipuleucel-T with ADT was generally well tolerated.Conclusions: Sipuleucel-T→ADT appears to induce greater antitumor immune responses than the reverse sequence. These results warrant further investigation to determine whether this sequence leads to improved clinical outcomes, as well as the independent contribution of ADT alone in terms of immune activation. Clin Cancer Res; 23(10); 2451–9. ©2016 AACR.

2017-04-01·Journal of the National Cancer Institute1区 · 医学

Role of Antigen Spread and Distinctive Characteristics of Immunotherapy in Cancer Treatment

1区 · 医学

Review

作者: Pachynski, Russell ; Gulley, James L ; Sheikh, Nadeem A ; Drake, Charles G ; Trager, James ; Mulders, Peter ; Madan, Ravi A

Immunotherapy is an important breakthrough in cancer. US Food and Drug Administration-approved immunotherapies for cancer treatment (including, but not limited to, sipuleucel-T, ipilimumab, nivolumab, pembrolizumab, and atezolizumab) substantially improve overall survival across multiple malignancies. One mechanism of action of these treatments is to induce an immune response against antigen-bearing tumor cells; the resultant cell death releases secondary (nontargeted) tumor antigens. Secondary antigens prime subsequent immune responses (antigen spread). Immunotherapy-induced antigen spread has been shown in clinical studies. For example, in metastatic castration-resistant prostate cancer patients, sipuleucel-T induced early immune responses to the immunizing antigen (PA2024) and/or the target antigen (prostatic acid phosphatase). Thereafter, most patients developed increased antibody responses to numerous secondary proteins, several of which are expressed in prostate cancer with functional relevance in cancer. The ipilimumab-induced antibody profile in melanoma patients shows that antigen spread also occurs with immune checkpoint blockade. In contrast to chemotherapy, immunotherapy often does not result in short-term changes in conventional disease progression end points (eg, progression-free survival, tumor size), which may be explained, in part, by the time taken for antigen spread to occur. Thus, immune-related response criteria need to be identified to better monitor the effectiveness of immunotherapy. As immunotherapy antitumor effects take time to evolve, immunotherapy in patients with less advanced cancer may have greater clinical benefit vs those with more advanced disease. This concept is supported by prostate cancer clinical studies with sipuleucel-T, PSA-TRICOM, and ipilimumab. We discuss antigen spread with cancer immunotherapy and its implications for clinical outcomes.

项与 Dendreon Pharmaceuticals, Inc. 相关的新闻（医药）

2024-05-10

·Pharmaceutical Technology

WestGene wins FDA approval for mRNA vaccine to treat certain cancers

Chinese biotech WestGene announced an FDA approval for its mRNA therapeutic cancer vaccine. Credit: aslysun via Shutterstock. The US Food and Drug Administration (FDA) has approved an mRNA therapeutic cancer vaccine developed by China-based biotech WestGene. This decision makes the vaccine the world’s first approved mRNA therapeutic vaccine to treat Epstein Barr (EB)-virus-related cancers. The approval was based on results from investigator-initiated trials that evaluated the vaccine in patients with nasopharyngeal carcinoma (NPC) and natural killer T cell lymphoma. EB virus is a part of the herpesvirus family and spreads primarily through bodily fluids. The illness infects more than 90% of the global adult population but does not always lead to cancer, as detailed by Cancer Research UK. The virus has been linked with NPC, gastric cancer, lung cancer and other diseases. In a 10 May press release, WestGene highlighted liver cancer, oesophageal cancer, breast cancer and the aforementioned diseases as potential future indications for the vaccine. The Chinese company has a pipeline that includes four infectious disease vaccines, seven anti-tumour immunotherapies, and three gene editing treatments amongst other therapies. See Also: Formosa and Tabuk sign deal for FDA-approved ophthalmic suspension Four ways the vaccine rush will define infectious disease trends for CROs in 2024 In 2010, the FDA approved Dendreon Pharmaceutical’s prostate cancer prophylactic Provenge (sipuleucel-T) as the first marketed therapeutic cancer vaccine. Since its approval, other therapeutic cancer vaccines have entered the US market, with eight being available in the US, according to GlobalData. GlobalData is the parent company of Pharmaceutical Technology. In 2021, Pfizer and BioNTech gained the first-ever FDA approval for an mRNA vaccine with Comirnaty (BNT162b2) as a preventative measure against Covid-19. Since this milestone, several preventive and therapeutic mRNA vaccines have been in development for a wide range of conditions. Some pharmaceutical companies are using the mRNA approach to develop vaccines for other infectious diseases such as respiratory syncytial virus (RSV), Influenza A, Influenza B and cytomegalovirus while companies, including Moderna , Curevac , and Cartesian Therapeutics, are developing therapeutic mRNA vaccines for treating different cancers.

疫苗上市批准免疫疗法信使RNA

2024-02-12

·Business Wire

Prostate Cancer Prevention and Treatment Technologies: Comprehensive Global Market Analysis - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Prevention and Treatment of Prostate Cancer: Technologies and Global Markets" report has been added to ResearchAndMarkets.com's offering. The global market for prostate cancer care reached $35.3 billion in 2022. This market is expected to reach $56.4 billion by the end of 2028, growing at a CAGR of 8.3% from 2023 through 2028. As the second most diagnosed male cancer in the world, prostate cancer affects roughly 1.4 million people and kills more than 370,000 men each year, which represents about 4% of all cancer deaths worldwide. This cancer ranges from being a non-aggressive, slow-growing type that can do without treatment to an aggressive, fast-growing disease that needs intervention and timely treatment. Hence, early detection/screening, diagnosis and staging of prostate cancer are critical. The global market for prostate cancer screening and detection is projected to grow at a CAGR of 5.8% to reach $19.8 billion by the end of 2028. It is estimated that over 60% of age-eligible men remain unscreened for prostate cancer. A large, underserved population of unscreened and inadequately screened patients represents a significant opportunity for non-invasive biomarker tests in the prostate cancer screening market. The global market for prostate cancer pharmaceuticals was valued at $16.0 billion in 2022 and is expected to reach $29.6 billion by the end of 2028, at a CAGR of 11.0% during the forecast period. Continued incidence of prostate cancer, the world's growing elderly population, and increasing therapeutic innovations are key driving factors in the market for prostate cancer drugs. The direct cost for radical prostatectomy was estimated at $3.6 billion in 2022. This cost is expected to rise to $4.8 billion by the end of 2028. The growing popularity of robot-assisted laparoscopic prostatectomy (RALP) is expected to impact the overall radical prostatectomy market. Improved screening programs will result in an increase in radical prostatectomies, as this procedure is preferred in early detection stages. The radiotherapy device market is expected to grow as the incidence of prostate cancer worldwide continues to increase and better and more accurate imaging technologies combined with precise treatment strategies are developed. This market is expected to reach $2.2 billion by the end of 2028. This research study analyzes the state of prostate cancer care, including screening, detection and treatment, offers revenue forecasts, assesses future trends, and provides recommendations for the success of market participants. The scope of the study is global. This report estimates market data for 2022 (the base year) and provides forecasts for 2023 through 2028. Figures for 2023 are estimated, except where actual results have been reported. This report includes forecasts by product type and region from 2023 through 2028. Genetic testing for inherited prostate cancer risk assessment is beyond the scope of the report. The Report Includes 31 data tables and 63 additional tables An overview of the global market for the technologies for prevention and treatment of prostate cancer Analysis of global market trends, featuring historical revenue data for 2020-2022, estimated figures for 2023, forecasts for 2024, and projections of compound annual growth rates (CAGRs) through 2028 Evaluation of the current market size and revenue growth prospects specific to prevention and treatment of prostate cancer, accompanied by a market share analysis by test type, treatment type, drug type and geographic region Description of several types of prostate cancer, namely acinar adenocarcinoma, ductal adenocarcinoma, transitional cell (or urothelial) cancer, small cell prostate cancer and carcinoid and sarcomas Description of biomarker tests such as the prostate-specific antigen (PSA) test, digital rectal exam (DRE) and prostate biopsy, and a discussion on their advantages and limitations Information on poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, their limitations and approvals related to their use as targeted therapy for prostate cancer Coverage of approvals for metastatic castration resistant prostate cancer (mCRPC), and collaborations and licensing agreements for the treatment of prostate cancer Evaluation of the current and future market potential and an analysis of the regulatory framework and reimbursement scenarios Review of patents, product pipelines, ESG trends and emerging technologies related to prevention and treatment of prostate cancer Market share analysis of the key companies in the industry and coverage of mergers & acquisitions, joint ventures, collaborations, partnerships and other market strategies Profiles of leading market participants Key Attributes: Report Attribute Details No. of Pages 157 Forecast Period 2023 - 2028 Estimated Market Value (USD) in 2023 $37.9 Billion Forecasted Market Value (USD) by 2028 $56.4 Billion Compound Annual Growth Rate 8.3% Regions Covered Global Key Topics Covered: Chapter 1 Introduction Chapter 2 Summary and Highlights Chapter 3 Market Overview Prostate Cancer Biology of Prostate Cancer Symptoms Screening Diagnosis Localized Prostate Cancer Metastatic Prostate Cancer Watchful Waiting or Active Surveillance Treatment Chapter 4 Market Dynamics Market Drivers Increasing Prevalence of Prostate Cancer Active Surveillance and Screening Personalized Care Approvals for Metastatic Castration-Resistant Prostate Cancer Collaborations and Licensing Agreements Market Challenges Loss of Exclusivity and Genericization Shortage of Care Providers and Other Resources Market Opportunities Chapter 5 Screening and Diagnosis Market by Test Type Biomarker Tests PSA Tests Limitations of PSA Tests Biomarker Tests for Early Prostate Cancer Detection in Elevated PSA Settings Digital Rectal Exam Limitations of DREs Prostate Biopsy Grade (Gleason Score) of Prostate Cancer Prostatic Intraepithelial Neoplasia Atypical Small Acinar Proliferation Proliferative Inflammatory Atrophy Intraductal Carcinoma of the Prostate Limitations of Prostate Biopsies Imaging Technologies for Prostate Cancer Market for Prostate Cancer Screening/Diagnosis, by Test Type Biomarker Tests DREs Prostate Biopsies Chapter 6 Pharmaceuticals Market by Drug Type Hormone Therapy Androgen Deprivation Therapy Antiandrogen Therapies Hormone Therapy Uses in Prostate Cancer Treatment Targeted Therapy PARP Inhibitors Radioligand Therapies Small Molecule Targeted Agents Monoclonal Antibodies Chemotherapy Immunotherapy Market Revenue, by Drug Type Hormone Therapy Targeted Therapy Immunotherapy Chemotherapy Chapter 7 Market for Surgery and Radiation Therapy by Treatment Type Active Surveillance Radical Prostatectomy Robotic Prostatectomy Open Radical Prostatectomy Laparoscopic Prostatectomy Radical Prostatectomy Market Revenue Radiation Therapy External Beam Radiation Therapy Brachytherapy Combined Radiation Therapy Radiation Therapy Device Market Revenue Chapter 8 Market Breakdown by Region Chapter 9 Emerging Technologies and Developments Liquid Biopsy Multiparametric MRI Homologous Recombination Repair Gene Mutation Advanced Radiotherapy Techniques AI and Machine Learning Chapter 10 Pipeline Analysis Chapter 11 Competitive Intelligence Screening and Diagnosis Market Market for Radiation Therapy Devices Pharmaceuticals Market Chapter 12 Company Profiles Abbott Accuray Astellas Pharma Astrazeneca Bayer Danaher Corp. Dendreon Pharmaceuticals Elekta F. Hoffmann-La Roche Johnson & Johnson Services Pfizer Sanofi Siemens Healthineers For more information about this report visit https://www.researchandmarkets.com/r/wra8q3 About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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2024-02-09

·PRNewswire

Prevention and Treatment of Prostate Cancer: Global Market for Prostate Cancer Screening and Detection is Projected to Grow at a CAGR of 5.8% to Reach $19.8 billion by 2028

DUBLIN, Feb. 9, 2024 /PRNewswire/ -- The "Prevention and Treatment of Prostate Cancer: Technologies and Global Markets" report has been added to ResearchAndMarkets.com's offering. The global market for prostate cancer care reached $35.3 billion in 2022. This market is expected to reach $56.4 billion by the end of 2028, growing at a CAGR of 8.3% from 2023 through 2028. As the second most diagnosed male cancer in the world, prostate cancer affects roughly 1.4 million people and kills more than 370,000 men each year, which represents about 4% of all cancer deaths worldwide. This cancer ranges from being a non-aggressive, slow-growing type that can do without treatment to an aggressive, fast-growing disease that needs intervention and timely treatment. Hence, early detection/screening, diagnosis and staging of prostate cancer are critical. The global market for prostate cancer screening and detection is projected to grow at a CAGR of 5.8% to reach $19.8 billion by the end of 2028. It is estimated that over 60% of age-eligible men remain unscreened for prostate cancer. A large, underserved population of unscreened and inadequately screened patients represents a significant opportunity for non-invasive biomarker tests in the prostate cancer screening market. The global market for prostate cancer pharmaceuticals was valued at $16.0 billion in 2022 and is expected to reach $29.6 billion by the end of 2028, at a CAGR of 11.0% during the forecast period. Continued incidence of prostate cancer, the world's growing elderly population, and increasing therapeutic innovations are key driving factors in the market for prostate cancer drugs. The direct cost for radical prostatectomy was estimated at $3.6 billion in 2022. This cost is expected to rise to $4.8 billion by the end of 2028. The growing popularity of robot-assisted laparoscopic prostatectomy (RALP) is expected to impact the overall radical prostatectomy market. Improved screening programs will result in an increase in radical prostatectomies, as this procedure is preferred in early detection stages. The radiotherapy device market is expected to grow as the incidence of prostate cancer worldwide continues to increase and better and more accurate imaging technologies combined with precise treatment strategies are developed. This market is expected to reach $2.2 billion by the end of 2028. This research study analyzes the state of prostate cancer care, including screening, detection and treatment, offers revenue forecasts, assesses future trends, and provides recommendations for the success of market participants. The scope of the study is global. This report estimates market data for 2022 (the base year) and provides forecasts for 2023 through 2028. Figures for 2023 are estimated, except where actual results have been reported. This report includes forecasts by product type and region from 2023 through 2028. Genetic testing for inherited prostate cancer risk assessment is beyond the scope of the report. The Report Includes 31 data tables and 63 additional tables An overview of the global market for the technologies for prevention and treatment of prostate cancer Analysis of global market trends, featuring historical revenue data for 2020-2022, estimated figures for 2023, forecasts for 2024, and projections of compound annual growth rates (CAGRs) through 2028 Evaluation of the current market size and revenue growth prospects specific to prevention and treatment of prostate cancer, accompanied by a market share analysis by test type, treatment type, drug type and geographic region Description of several types of prostate cancer, namely acinar adenocarcinoma, ductal adenocarcinoma, transitional cell (or urothelial) cancer, small cell prostate cancer and carcinoid and sarcomas Description of biomarker tests such as the prostate-specific antigen (PSA) test, digital rectal exam (DRE) and prostate biopsy, and a discussion on their advantages and limitations Information on poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, their limitations and approvals related to their use as targeted therapy for prostate cancer Coverage of approvals for metastatic castration resistant prostate cancer (mCRPC), and collaborations and licensing agreements for the treatment of prostate cancer Evaluation of the current and future market potential and an analysis of the regulatory framework and reimbursement scenarios Review of patents, product pipelines, ESG trends and emerging technologies related to prevention and treatment of prostate cancer Market share analysis of the key companies in the industry and coverage of mergers & acquisitions, joint ventures, collaborations, partnerships and other market strategies Profiles of leading market participants Key Topics Covered: Chapter 1 Introduction Chapter 2 Summary and Highlights Chapter 3 Market Overview Prostate Cancer Biology of Prostate Cancer Symptoms Screening Diagnosis Localized Prostate Cancer Metastatic Prostate Cancer Watchful Waiting or Active Surveillance Treatment Chapter 4 Market Dynamics Market Drivers Increasing Prevalence of Prostate Cancer Active Surveillance and Screening Personalized Care Approvals for Metastatic Castration-Resistant Prostate Cancer Collaborations and Licensing Agreements Market Challenges Loss of Exclusivity and Genericization Shortage of Care Providers and Other Resources Market Opportunities Chapter 5 Screening and Diagnosis Market by Test Type Biomarker Tests PSA Tests Limitations of PSA Tests Biomarker Tests for Early Prostate Cancer Detection in Elevated PSA Settings Digital Rectal Exam Limitations of DREs Prostate Biopsy Grade (Gleason Score) of Prostate Cancer Prostatic Intraepithelial Neoplasia Atypical Small Acinar Proliferation Proliferative Inflammatory Atrophy Intraductal Carcinoma of the Prostate Limitations of Prostate Biopsies Imaging Technologies for Prostate Cancer Market for Prostate Cancer Screening/Diagnosis, by Test Type Biomarker Tests DREs Prostate Biopsies Chapter 6 Pharmaceuticals Market by Drug Type Hormone Therapy Androgen Deprivation Therapy Antiandrogen Therapies Hormone Therapy Uses in Prostate Cancer Treatment Targeted Therapy PARP Inhibitors Radioligand Therapies Small Molecule Targeted Agents Monoclonal Antibodies Chemotherapy Immunotherapy Market Revenue, by Drug Type Hormone Therapy Targeted Therapy Immunotherapy Chemotherapy Chapter 7 Market for Surgery and Radiation Therapy by Treatment Type Active Surveillance Radical Prostatectomy Robotic Prostatectomy Open Radical Prostatectomy Laparoscopic Prostatectomy Radical Prostatectomy Market Revenue Radiation Therapy External Beam Radiation Therapy Brachytherapy Combined Radiation Therapy Radiation Therapy Device Market Revenue Chapter 8 Market Breakdown by Region Chapter 9 Emerging Technologies and Developments Liquid Biopsy Multiparametric MRI Homologous Recombination Repair Gene Mutation Advanced Radiotherapy Techniques AI and Machine Learning Chapter 10 Pipeline Analysis Chapter 11 Competitive Intelligence Screening and Diagnosis Market Market for Radiation Therapy Devices Pharmaceuticals Market Chapter 12 Company Profiles Abbott Accuray Astellas Pharma Astrazeneca Bayer Danaher Corp. Dendreon Pharmaceuticals Elekta F. Hoffmann-La Roche Johnson & Johnson Services Pfizer Sanofi Siemens Healthineers For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

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药物(靶点)	适应症	全球最高研发状态

Sipuleucel-T (Dendreon Corporation)	转移性去势抵抗性前列腺癌更多	批准上市
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