Provenge (sipuleucel-T) / Bausch Health 
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 10 Diseases   5 Trials   5 Trials   1130 News 


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  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    [VIRTUAL] IMPACT OF LYMPHADENECTOMY ON THE RESPONSE TO SIPULEUCEL-T TREATMENT OF METASTATIC CASTRATE-RESISTANT PROSTATE CANCER () -  Nov 20, 2020 - Abstract #SUO2020SUO_282;    
    P1
    LND around the time of Sip-T treatment of mCRPC may have favorable effects on disease response in select patients with long baseline PSA doubling time and ability to undergo complete resection. Further study of the immune signatures of these phenomena will allow better understanding of the applicability of extirpation in metastatic prostate cancer, as well as the predictors of favorable response to Sip-T in lymph node predominant mCRPC.Funding: Dendreon
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health, Xofigo (radium Ra-223 dichloride) / Bayer
    Trial completion date, Trial primary completion date, Metastases:  Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC (clinicaltrials.gov) -  Nov 13, 2020   
    P2,  N=36, Active, not recruiting, 
    Further study of the immune signatures of these phenomena will allow better understanding of the applicability of extirpation in metastatic prostate cancer, as well as the predictors of favorable response to Sip-T in lymph node predominant mCRPC.Funding: Dendreon Trial completion date: Dec 2020 --> Mar 2021 | Trial primary completion date: Nov 2020 --> Feb 2021
  • ||||||||||  Review, Journal:  Novel Therapeutic Strategies for CDK4/6 Inhibitors in Metastatic Castrate-Resistant Prostate Cancer. (Pubmed Central) -  Nov 1, 2020   
    Response to CDK4/6 inhibitors may be predicted by the tumors' genomic profile and may provide insight into combinatory therapy with CDK4/6 inhibitors in order to delay resistance or provide synergistic effects. Here, we review the use of CDK4/6 inhibitors in prostate cancer and potential combinations based on known resistance mechanisms to CDK4/6 inhibitors, prostate cancer regulatory pathways, and prostate-cancer-specific genomic alterations.
  • ||||||||||  AE 37 / Generex, Provenge (sipuleucel-T) / Bausch Health
    Review, Journal:  Exploring Essential Issues for Improving Therapeutic Cancer Vaccine Trial Design. (Pubmed Central) -  Oct 21, 2020   
    Although scientists working on cancer immunotherapy feel that this is an essential breakthrough for the field, they still expect that new vaccine regimens will yield better clinical benefits compared to the four months prolonged median overall survival (OS) Sipuleucel-T demonstrated in the IMPACT phase III clinical trial...Thus, rigorous re-evaluation of these trials is urgently required in order to redefine aspects and optimize the benefits offered by therapeutic cancer vaccines. The scope of this review is to provide to the reader our thoughts on the key challenges in maximizing the therapeutic potentials of cancer vaccines, with a special focus on issues that touch upon clinical trial design.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health, ProstVac (rilimogene galvacirepvec) / BMS
    Biomarker, Review, Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, IO Biomarker:  Immunotherapy for Localized Prostate Cancer: The Next Frontier? (Pubmed Central) -  Oct 15, 2020   
    Nevertheless, efforts are ongoing to help prime prostate tumors by turning a "cold" prostate cancer "hot" and thus rendering them more susceptible to immunotherapy. Combination treatments, use of molecular biomarkers, and use of new immunotherapeutic agents provide opportunities to enhance the immune response to prostate tumors.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Review, Journal, Tumor Mutational Burden, IO Biomarker:  Immunotherapy for Prostate Cancer: Treatments for the "Lethal" Phenotype. (Pubmed Central) -  Oct 15, 2020   
    Although checkpoint inhibitors have been largely ineffective, there remain small cohorts of patients who have durable responses but lack the conventional indicators for response to this class of drugs, that is, high mutational burden or significant genomic alterations, as seen in other solid tumors. This article presents an update on the evolution of immunotherapeutics that target a more lethal form of prostate cancer and provides the groundwork for future considerations as to how this field should proceed.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    [VIRTUAL] Pleiotropic effects of IL-7 in prostate cancer patients receiving Sipuleucel-T vaccination () -  Oct 14, 2020 - Abstract #SITC2020SITC_1297;    
    P2
    Conclusions Altogether, our data revealed multiple effects of IL-7 in these patients, highlighting a complex set of in vivo mechanisms. In the future, knowledge of these effects may help in choosing the best agents to use in combination with IL-7 and/or the best patients to benefit from IL-7 as part of their therapeutic approach.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    [VIRTUAL] A Novel Prostate-Restricted Tumor-Associated Antigen: A Potential Therapeutic Target () -  Oct 14, 2020 - Abstract #SITC2020SITC_1205;    
    Although immunological treatment with the FDA-approved vaccine sipuleucel-T extends survival for 2–4 months by targeting the prostate-restricted antigen PAP, the identification of more immunogenic tumor-associated antigens (TAAs) continues to be an unmet need...An IgG antibody response to this novel TAA was detected in 30% of vaccinated patients, while fewer than 8% of vaccinated patients developed antibody responses to PSA or PSMA. Conclusions Taken together, these results suggest we have found a novel immunogenic prostate-restricted TAA that represents a promising therapeutic target for treating mCRPC.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    [VIRTUAL] Pleiotropic effects of IL-7 in prostate cancer patients receiving Sipuleucel-T vaccination () -  Oct 14, 2020 - Abstract #SITC2020SITC_562;    
    P2
    Conclusions Altogether, our data revealed multiple effects of IL-7 in these patients, highlighting a complex set of in vivo mechanisms. In the future, knowledge of these effects may help in choosing the best agents to use in combination with IL-7 and/or the best patients to benefit from IL-7 as part of their therapeutic approach.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    [VIRTUAL] A Novel Prostate-Restricted Tumor-Associated Antigen: A Potential Therapeutic Target () -  Oct 14, 2020 - Abstract #SITC2020SITC_470;    
    Although immunological treatment with the FDA-approved vaccine sipuleucel-T extends survival for 2–4 months by targeting the prostate-restricted antigen PAP, the identification of more immunogenic tumor-associated antigens (TAAs) continues to be an unmet need...An IgG antibody response to this novel TAA was detected in 30% of vaccinated patients, while fewer than 8% of vaccinated patients developed antibody responses to PSA or PSMA. Conclusions Taken together, these results suggest we have found a novel immunogenic prostate-restricted TAA that represents a promising therapeutic target for treating mCRPC.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Review, Journal:  Treatment Combinations with DNA Vaccines for the Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC). (Pubmed Central) -  Oct 5, 2020   
    One antitumor vaccine, sipuleucel-T, has been approved as a treatment for mCRPC...We reviewed the literature available prior to July 2020 exploring the use of DNA vaccines in the treatment of prostate cancer. We also examined various approved and experimental therapies that could be combined with DNA vaccines to potentially improve their antitumor efficacy as treatments for mCRPC.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Clinical, Review, Journal:  Clinical application of immune checkpoints in targeted immunotherapy of prostate cancer. (Pubmed Central) -  Oct 4, 2020   
    In fact, the first cancer vaccine approved by FDA was Provenge, which has been successfully used for treatment of PCa...The present review particularly focuses on the latest findings of the immune checkpoints (ICPs), including CTLA-4, PD-1, PD-L1, LAG-3, OX40, B7-H3, 4-1BB, VISTA, TIM-3, and ICOS; these checkpoints are able to have immune modulatory effects on the TME of PCa. This paper further discusses different approaches in ICPs targeting therapy and summarizes the latest advances in the clinical application of ICP-targeted therapy as monotherapy or in combination with other cancer therapy modalities in PCa.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Review, Journal:  Immunotherapy in prostate cancer: current state and future perspectives. (Pubmed Central) -  Sep 23, 2020   
    In this review, the physiology of the cancer immunity cycle is highlighted in the context of the prostate tumor microenvironment, and the current evidence for use of various classes of immunotherapy agents including vaccines (dendritic cell based, viral vector based and DNA/mRNA based), immune checkpoint inhibitors, Chimeric antigen receptor T cell therapy, antibody-mediated radioimmunotherapy, antibody drug conjugates, and bispecific antibodies, is consolidated. Finally, the future directions for combinatorial approaches to combat PCa are discussed.
  • ||||||||||  Journal:  Pharmacotherapeutic strategies for castrate-resistant prostate cancer. (Pubmed Central) -  Sep 20, 2020   
    Sipuleucel-T has been approved for the treatment of asymptomatic or minimally symptomatic mCRPC...Cabazitaxel has been approved as the second line treatment to docetaxel in mCRPC...Carbazitaxel seemed to retain its activity regardless of the treatment sequence. Of note, ENZ and apalutamide have been approved in non-metastatic CRPC.
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Provenge (Twitter) -  Aug 31, 2020   
  • ||||||||||  Provenge (sipuleucel-T) / Bausch Health
    Journal:  Listeria monocytogenes as a Vector for Cancer Immunotherapy. (Pubmed Central) -  Aug 9, 2020   
    Cancer immunotherapies have become a reality, with the first approval for sipuleucel-T for prostate cancer therapy occurring in 2010...However, since in the majority of cases the human immune system is able to mount potent innate and adaptive immune responses that control infections by Listeria monocytogenes, the microorganism has become an attractive vector for the development of cancer vaccines. The review by Flickinger Jr., Rodeck and Snook (Vaccines 2018, 6, 48) on the use of Listeria monocytogenes as a vector for cancer immunotherapy is described and commented here.
  • ||||||||||  Clinical, Review, Journal:  PSMA radioligand therapy in patients with advanced prostate cancer (Pubmed Central) -  Jul 3, 2020   
    Although patient selection could account for some or all of these results, these data support the utilization of sipuleucel-T alone in select mCRPC patients that is associated with a delay in disease progression and a good overall prognosis. Despite the promising preliminary results of Lu-PSMA-RLT, the efficacy results of VISION need to be awaited prior to using the therapy outside of compassionate use provisions.