Provenge (sipuleucel-T) / Bausch Health 
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  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Journal:  Videos of Sipuleucel-T Programmed T Cells Lysing Cells That Express Prostate Cancer Target Antigens. (Pubmed Central) -  Mar 23, 2022   
    P2
    Differentially stained effector and target cells were then video-recorded during co-culture. Here, we present video recordings and analyses of T cells from sipuleucel-T-treated subjects showing-for the first time-direct lysis of cells that express prostate cancer target antigens, PAP or prostate-specific antigen.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Biomarker, Journal:  Analysis of Circulating Immune Biomarkers by Race in Men with Metastatic Castration-Resistant Prostate Cancer Treated with Sipuleucel-T. (Pubmed Central) -  Mar 23, 2022   
    Black men had statistically significantly higher median concentrations of TH2-type (IL-4, IL-10, and IL-13) and inflammatory cytokines (IL-2, IL-12, and IL-6) compared to PSA-matched White men both at baseline and 52 weeks after sipuleucel-T (2-sided P < .05). No differences by race were seen in either the antigen-specific T cell response or in the humoral responses to the immunizing antigen PA2024 and select secondary antigens.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    High dimensional analysis of sipuleucel T from metastatic castration resistant prostate cancer patients using mass cytometry (Section 34) -  Mar 9, 2022 - Abstract #AACR2022AACR_5836;    
    This is the first comprehensive study to evaluate the composition of sip T from mCRPC patients using high dimensional CyTOF analysis. Given the increasing use of CyTOF in translational research, this data set serves as an important reference source, which could be used in future studies to help guide therapeutic modulation of activation/exhaustion markers to improve sip T efficacy and enhance beneficial immune responses.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Clinical, Review, Journal:  Racial disparity in prostate cancer in the African American population with actionable ideas and novel immunotherapies. (Pubmed Central) -  Mar 8, 2022   
    Also, a summary of current clinical trials involving AA men is presented, and it is important that policies are adopted to ensure that AA men are actively recruited. Although it is encouraging that many of these explore the lifestyle and educational initiatives and therapeutic interventions, there is much still work to be done to reduce incidence and mortality in AA men and equalize current racial disparities.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Provenge (sipuleucel-T) / Bausch Health
    Biomarker, Review, Journal, Tumor microenvironment:  Immunotherapy in treatment of metastatic prostate cancer: An approach to circumvent immunosuppressive tumor microenvironment. (Pubmed Central) -  Feb 25, 2022   
    As various immunosuppressive mechanisms coexist and cross-interact within the tumor microenvironment, different immunotherapy approaches may have to be combined and selected in a highly personalized way. It is hoped that this rapidly evolving field of immunotherapy will achieve successful treatment for mCRPC and will be applied to a wider range of prostate cancer patients.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Journal, IO biomarker:  TGM4: an immunogenic prostate-restricted antigen. (Pubmed Central) -  Jan 12, 2022   
    Additional study to confirm these findings in a larger trial is warranted. These results suggest that TGM4 is an immunogenic, prostate-restricted antigen with the potential for further development as an immunotherapy target.
  • ||||||||||  Review, Journal:  DENDRITIC CELL VACCINE THERAPY FOR COLORECTAL CANCER. (Pubmed Central) -  Jan 6, 2022   
    The unparalleled success of Sipuleucel-T has helped revitalize the clinical development of dendritic cell vaccines, which will be examined in this review. We also highlight the promise of these vaccines to instill anti-angiogenic immunity for individuals with advanced colorectal cancer.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Use of bone modifying agents for metastatic castrate-resistant prostate cancer. (In-Person & On Demand | Level 1, West Hall) -  Jan 5, 2022 - Abstract #ASCOGU2022ASCO_GU_287;    
    In most cases BMA therapy was initiated while patients still had castrate-sensitive disease, for which BMAs are indicated only at lower doses for the prevention of osteoporotic fractures. Further work is needed to understand whether real-world dosing is in line with clinical indications, and whether the one-third of patients who did not receive BMA therapy appropriately reflects the proportion of patients with contraindications.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo
    Real-world treatment patterns among patients with metastatic castration-resistant prostate cancer (mCRPC) in the US. (In-Person & On Demand | Level 1, West Hall - B12) -  Jan 5, 2022 - Abstract #ASCOGU2022ASCO_GU_281;    
    With rapidly evolving treatment options in metastatic prostate cancer, these data can help guide estimation of eligible patients for different clinical trials. Further studies are needed to understand the high attrition from 1L to subsequent lines of therapy, the reasons for treatment preference and impact on clinical outcomes with different treatment sequencings.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Provenge (sipuleucel-T) / Bausch Health
    Review, Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker:  Refining Immuno-Oncology Approaches in Metastatic Prostate Cancer: Transcending Current Limitations. (Pubmed Central) -  Jan 5, 2022   
    The future will incorporate bispecific antibodies and chimeric antigen receptor (CAR)-T cells, potentially targeted towards phenotypic markers identified by next-generation PET imaging as part of the next wave of "precision medicine" in prostate cancer. Ultimately, we believe that the immune-exclusive prostate cancer tumor microenvironment can be overcome, and that patient outcomes can be enhanced through these more refined immuno-oncology approaches.
  • ||||||||||  Review, Journal, PARP Biomarker, IO biomarker:  Drug and molecular radiotherapy combinations for metastatic castration resistant prostate cancer. (Pubmed Central) -  Dec 18, 2021   
    In the field of immunotherapy, checkpoint inhibition as well as sipuleucel-T and PROSTVAC demonstrated only limited efficacy in mCRPC when used as monotherapy. This review discusses recent therapeutic strategies for mCRPC highlighting the need for rational combination of treatment options.
  • ||||||||||  abiraterone acetate / Generic mfg., docetaxel / Generic mfg.
    Review, Journal:  Racial Disparity in Response to Prostate Cancer Systemic Therapies. (Pubmed Central) -  Nov 11, 2021   
    The mechanisms for this are being further explored. African Americans may respond better to mCRPC treatments but validation in prospective clinical trials is needed.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health, ProstVac (rilimogene galvacirepvec) / Bavarian Nordic
    Review, Journal:  Therapeutic metastatic prostate cancer vaccines: lessons learnt from urologic oncology. (Pubmed Central) -  Nov 5, 2021   
    Currently, both vaccines have been tested in combination with other therapeutic approaches, including check point inhibitors. It seems possible that the efficacy of sipuleucel-T and PROSTVAC could be increased in combination therapy with other medications.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Journal:  Targeting the spectrum of immune checkpoints in prostate cancer. (Pubmed Central) -  Oct 16, 2021   
    Introduction: The proven efficacy of the cellular vaccine sipuleucel-T in 2010 led to optimism about immunotherapeutic approaches for the treatment of prostate cancer...We provide an overview of alternate immune checkpoints that may hold greater significance in this disease.Expert opinion: Combination therapies to target multiple layers of alternate immune checkpoints may be required for an effective immune response to prostate cancer. We discuss combination therapies currently being investigated.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Journal:  Evolving Role of Immunotherapy in Metastatic Castration Refractory Prostate Cancer. (Pubmed Central) -  Oct 8, 2021   
    Sipuleucel-T remains the only approved immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant prostate cancer based on modest improvement in overall survival...We describe the results of clinical trials of immune checkpoint inhibitors in patients with metastatic castration-resistant prostate cancer; either as single agents or in combination with other checkpoint inhibitors, poly (ADP-ribose) polymerase (PARP) inhibitors, tyrosine kinase inhibitors, novel hormonal therapies, chemotherapies, and radioligands. Finally, we review upcoming immunotherapies, including novel monoclonal antibodies, chimeric-antigen receptor (CAR) T cells, Bi-Specific T cell Engagers (BiTEs), therapies targeting the adenosine pathway, and other miscellaneous agents.
  • ||||||||||  Xofigo (radium Ra-223 dichloride) / Bayer
    Review, Journal:  Advanced Prostate Cancer: Treatment Advances and Future Directions. (Pubmed Central) -  Oct 2, 2021   
    We summarize clinical trials leading to recent drug approvals and discuss optimal treatment selection. We also review recent advances in genomics including its evolving role in prognosis, in elucidating mechanisms of treatment resistance, and in guiding treatment decisions.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), Provenge (sipuleucel-T) / Bausch Health
    Journal, PD(L)-1 Biomarker, IO biomarker:  Immunotherapy in prostate cancer: new horizon of hurdles and hopes. (Pubmed Central) -  Oct 2, 2021   
    We also review recent advances in genomics including its evolving role in prognosis, in elucidating mechanisms of treatment resistance, and in guiding treatment decisions. Despite immunosuppressive functional status of PCa microenvironment, current evidence, based on cellular and molecular conditions, encourages further research in this field.
  • ||||||||||  90Y-NM600 / Archeus Technologies, Provenge (sipuleucel-T) / Bausch Health
    Combination of antigen-specific vaccination and targeted radionuclide therapy improves anti-tumor efficacy in a murine prostate model (Poster Hall) -  Oct 1, 2021 - Abstract #SITC2021SITC_1032;    
    Background While checkpoint blockade has been unsuccessful in prostate cancer trials, the approval of Sipuleucel-T demonstrates the value of antigen-specific vaccination approaches for this disease...An intravenous injection was administered of 50 (”low-dose”) or 250 μCi (”high dose”) of 90Y-NM600, estimated to deliver a dose of 3.1 Gy or 15.5 Gy to 300 mm3 tumors, respectively...Conclusions These data suggest that the combination of antigen-specific vaccination and TRT can be an effective treatment for cancers that are refractory to immunotherapy. This combination may act through increasing co-stimulation by dendritic cells, leading to a more active cytolytic CD8+ T cell population.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Review, Journal:  Moving on From Sipuleucel-T: New Dendritic Cell Vaccine Strategies for Prostate Cancer. (Pubmed Central) -  Sep 24, 2021   
    In this review we will analyze why newer vaccine strategies using monocyte derived DC (MoDC) have failed to deliver clinical benefit, particularly in PCa, and highlight the emerging antigen loading and presentation technologies such as nanoparticles, antibody-antigen conjugates and virus co-delivery systems that can be used to improve efficacy. Lastly, we will assess combination strategies that can help overcome the immunosuppressive microenvironment of PCa.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Clinical, Preclinical, Journal:  Dendritic Cells Pulsed with Cytokine-Adjuvanted Tumor Membrane Vesicles Inhibit Tumor Growth in HER2-Positive and Triple Negative Breast Cancer Models. (Pubmed Central) -  Sep 22, 2021   
    The only FDA approved DC-based immunotherapy to date is Sipuleucel-T, which utilizes a fusion protein to stimulate DCs ex vivo with GM-CSF and simultaneously deliver the antigen PAP for prostate cancer...Adaptive transfer of TMV-pulsed DCs to tumor bearing mice results in the inhibition of tumor growth, reduction in lung metastasis, and an increase in immune cell infiltration into the tumors. These observations suggest that DCs pulsed with TMVs containing GPI-GM-CSF and GPI-IL-12 can be further developed to be used as a personalized immunotherapy platform for cancer treatment.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Journal, IO biomarker:  Fusion Protein Vaccine Based on Ag85B and STEAP1 Induces a Protective Immune Response against Prostate Cancer. (Pubmed Central) -  Aug 7, 2021   
    Immunotherapy involving Sipuleucel-T has increasingly drawn attention for prostate cancer management...The immune response against prostate cancer was greatly suppressed when the antigen targets were knocked out using CRISPR-Cas9. (4) In summary, our results provide the first evidence that a vaccine based on a fusion protein consisting of Ag85B and a prostate cancer octapeptide epitope with complete Freund's adjuvant (CFA), triggers a robust immune response and inhibits tumor growth in murine prostate cancer.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Trial completion, Trial completion date, Metastases:  Radiation Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Receiving Sipuleucel-T (clinicaltrials.gov) -  Aug 5, 2021   
    P=N/A,  N=15, Completed, 
    (4) In summary, our results provide the first evidence that a vaccine based on a fusion protein consisting of Ag85B and a prostate cancer octapeptide epitope with complete Freund's adjuvant (CFA), triggers a robust immune response and inhibits tumor growth in murine prostate cancer. Active, not recruiting --> Completed | Trial completion date: Jun 2021 --> Jan 2021
  • ||||||||||  docetaxel / Generic mfg.
    [VIRTUAL] Racial Disparity in The Utilization of New Therapies for Advanced Prostate Cancer () -  Aug 5, 2021 - Abstract #AUA2021AUA_2311;    
    FDA approval of Sipuleucel-T in 2010 for mCRPC led to increased utilization of immunotherapy shortly thereafter, but this was mainly in white patients.  Black and Hispanic patients proportionately did not exhibit increased utilization of this novel agent after 2010. Further study is necessary to help understand barriers to access to new treatment in mCRPC and eliminate the burden of disease in minority populations.
  • ||||||||||  Prolia (denosumab) / Amgen, Daiichi Sankyo, Xofigo (radium Ra-223 dichloride) / Bayer
    [VIRTUAL] What's New in the Management of Hormone Naïve & Castrate Resistant Prostate Cancer: A Case-based Session for Urologists, Advanced Practice Providers and Teams (Marco Polo 801) -  Jul 13, 2021 - Abstract #AUA2021AUA_794;    
    We aim to allow urologists and their practice teams to be comfortable prescribing the following agents: abiraterone, enzalutamide, apalutamide, daralutamide, radium-223, denosumab, Sipuleucel-T and understand systemic chemotherapy, PARP inhibitors and emerging immunotherapy.Learning Objectives: List the three main advanced prostate cancer disease states (HSMPC); M0 CRPC and M1 CRPC) and be able to identify these patients in urologic practice.Identify FDA-hormonal and non-hormonal therapies for use in each of these three disease states: HSMPC, M0 CRPC, M1 CRPC.Demonstrate the safe use and unique mechanism of action and side effects of new and existing agents. Explain the sequencing of novel therapies and be able to identify patient progression of disease by PSA, imaging and signs and symptoms.Work in team care including urologists, advanced practice providers, oncology nursing, oncology pharmacy, medical oncology and radiation oncology and their support staffs.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health, Xofigo (radium Ra-223 dichloride) / Bayer
    Trial completion, Metastases:  Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC (clinicaltrials.gov) -  Jul 8, 2021   
    P2,  N=36, Completed, 
    Explain the sequencing of novel therapies and be able to identify patient progression of disease by PSA, imaging and signs and symptoms.Work in team care including urologists, advanced practice providers, oncology nursing, oncology pharmacy, medical oncology and radiation oncology and their support staffs. Active, not recruiting --> Completed