Provenge (sipuleucel-T) / Bausch Health - LARVOL DELTA

Treatment patterns and survival by race among men with metastatic castration-resistant prostate cancer (mCRPC) in the United States: A US electronic medical record database 2020-2023. (ASCO 2025) - "Line of therapy was identified as ARPI, chemotherapy, poly (ADP-ribose) polymerase inhibitors (PARPIs), immunotherapy (pembrolizumab, sipuleucel-T), radiopharmaceuticals (Ra-223, 177Lu-PSMA-RLT), alone or in combination...Overall, ARPI (62%) [abiraterone: 25%; enzalutamide: 24%; apalutamide: 9%; darolutamide 4%] and chemotherapy (22%) [docetaxel 16%; cabazitaxel 6%] were most common first-line treatment (1L Tx) for mCRPC... ARPI and chemotherapy remained the most utilized therapies in mCRPC from 2020 to 2023 in the US. Treatment and survival outcomes did not differ significantly between Whites and AAs in mCRPC. Treatment and survival by race in mCRPC.NE, not evaluable."

Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR

Real-world outcomes among patients with metastatic castration-resistant prostate cancer (mCRPC) receiving guideline-recommended therapies after treatment with 177Lu-PSMA-617: A real-world prostate cancer disease observation (PRECISION) data platform analysis. (ASCO 2025) - "Guideline-recommended therapies included abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel, pembrolizumab, sipuleucel-T, niraparib, olaparib, talazoparib, rucaparib, and radium-223. In this real-world analysis, the majority of patients who received guideline-recommended therapies after 177Lu-PSMA-617 achieved at least a PSA50 response, suggesting that 177Lu-PSMA-617 treatment does not preclude response to other subsequent therapies."

Clinical • Metastases • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology

Real-world treatment patterns, sequences, and outcomes in patients with mCRPC in US urology clinics. (ASCO 2025) - "Of the 1,914 patients treated with androgen receptor pathway inhibitors (ARPIs) pre-mCRPC, including enzalutamide (enza), abiraterone (abi), apalutamide, and darolutamide, 95.8%, were treated with ARPI ± ADT. This data indicates the majority of patients used ADT alone pre-mCRPC. ARPI rechallenge was the most common treatment sequence from pre-mCRPC to mCRPC among ARPI exposed patients. Less than half of the patients analyzed received 2L+ therapy."

Clinical • HEOR • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Prostate Cancer • Urology

Overall survival outcomes with sipuleucel-T (Sip-T) among Black men with metastatic castrate-resistant prostate cancer (mCRPC) also treated with androgen receptor pathway inhibitors (ARPI). (ASCO 2025) - "Our findings from an investigator-led retrospective analysis independent of sponsors provide independent clinical trial support of prior retrospective findings that suggest Black men with mCRPC who receive Sip-T may have a greater OS than White men. While our analysis controlled for factors that may influence the use of Sip-T, it is limited by potential unmeasured confounders or timing of Sip-T. Further, adequately powered prospective trials specifically evaluating outcomes with Sip-T by race in earlier clinical settings are needed."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Overall survival in metastatic castration-resistant prostate cancer (mCRPC): A retrospective electronic medical record analysis of men treated with sipuleucel-T in community urology over 14 years. (ASCO 2025) - "Despite their high-risk disease, patients who received sipuleucel-T had a 44-month median OS, with 28% being alive at 5 years later. This highlights the potential therapeutic benefit of integrating sipuleucel-T into real-world treatment for mCRPC. Further analysis is needed, leveraging the rich nature of this dataset."

Metastases • Retrospective data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology

Real-world outcomes among patients with metastatic castration-resistant prostate cancer (mCRPC) receiving guideline-recommended therapies after treatment with 177Lu-PSMA-617: A real-world prostate cancer disease observation (PRECISION) data platform analysis. (ASCO-GU 2025) - "Guideline-recommended therapies included abiraterone, enzalutamide, darolutamide, apalutamide, cabazitaxel, docetaxel, pembrolizumab, sipuleucel-T, niraparib, olaparib, talazoparib, rucaparib, and radium-223. In this real-world analysis, the majority of patients who received guideline-recommended therapies after 177Lu-PSMA-617 achieved at least a PSA50 response, suggesting that 177Lu-PSMA-617 treatment does not preclude response to other subsequent therapies."

Clinical • Metastases • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Systemic Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer: ASCO Guideline Update. (PubMed, J Clin Oncol) - "Prior systemic therapy for castration-sensitive prostate cancer will determine subsequent therapy used for mCRPC. Continue androgen-deprivation therapy for patients with mCRPC indefinitely. Early adoption of somatic genetic testing and palliative care is recommended. Patients with mCRPC and bony metastases should receive a bone-protective agent. The panel recommends the combination of ARPI with PARPi in patients with BRCA1/2 alterations who did not receive prior ARPI. For patients who received prior ARPI, the panel recommends docetaxel chemotherapy. The panel recommends 177Lu-PSMA-617 or cabazitaxel chemotherapy for patients who receive prior ARPI and docetaxel chemotherapy. For patients with BRCA1/2 alterations who received prior ARPI, the panel recommends PARPi monotherapy. Radium 223 is recommended for patients with symptomatic bone-only disease. Evidence for optimal sequencing for mCRPC regimens is lacking.Additional information is available at..."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Microsatellite Instability • Oncology • Palliative care • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • MSI

Focus on urological cancer (ESTRO 2025) - "Clinical trials exploring the combination of brachytherapy with immunotherapies such as nivolumab, pembrolizumab, durvalumab and others are ongoing, with preliminary data indicating improved outcomes in patients with advanced prostate cancer (2, 3)...However, based on the results of phase II trials, no statistically significant improvement in oncological outcomes was observed in patients receiving both sipuleucel-T and radiotherapy (5)...Although combining brachytherapy with immunotherapy holds promise, further research is required to optimise treatment regimens, including dose, fractionation, timing, and sequencing. Prospective clinical trials are critical to better understanding the interaction between these modalities."

IO biomarker • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urethral Cancer • Urology

Diversity, Equity, and Inclusion in Gene and Cell Therapies Clinical Trials (ISPOR 2025) - "The lowest enrollment was for atidarsagene autotemcel (7 participants), while sipuleucel-T had the highest (512 participants)...White participants were disproportionately represented, particularly in sipuleucel-T (90.0%) and talimogene laherparepvec (97.9%)... The findings revealed persistent racial disparities in gene and cell therapy clinical trials, with minority populations underrepresented and White participants comprising the majority. Achieving DEI in clinical trials remains a challenge, underscoring the need for greater efforts to address these disparities."

Clinical • Gene Therapies • Oncology

Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer (clinicaltrials.gov) - P2 | N=26 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Mar 2025 ➔ Aug 2025

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

mRNA vaccines for prostate cancer: A novel promising immunotherapy. (PubMed, Biochim Biophys Acta Rev Cancer) - "These attempts have largely failed to improve survival, with the sole exception of sipuleucel-T, which extended the median overall survival of asymptomatic or minimally symptomatic metastatic CRPC (mCRPC) patients by four months...Compared to conventional vaccines, mRNA vaccines offer several unique advantages, including high production efficiency, low cost, high safety, strong immune response induction, and high adaptability and precision. These attributes make mRNA vaccines a promising frontier in the treatment of advanced PCa."

Journal • Review • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Infectious Disease • Novel Coronavirus Disease • Oncology • Prostate Cancer • Solid Tumor

EAU 2025: A Case of Progression After Triplet Therapy for mHSPC: Evidence for and Against a Second ARPI (UroToday) - "Of 2,559 patients with mCRPC, 1,980 (77%) received at least one line of life-prolonging therapy (abiraterone, enzalutamide, docetaxel, cabazitaxel, sipuleucel-T, or radium-223)...Dr. Tombal noted that each time a second androgen receptor pathway inhibitor has been used as a 'best valuable comparator', it showed significantly lower radiographic progression free survival and overall survival in most cases...Prolonged responses are sometimes seen, but androgen receptor pathway inhibitor switch should not replace active treatments such as cabazitaxel, PARP inhibitors, LuPSMA, or radium-223...One interpretation of PSMAfore is that slightly delaying the following line of treatment with an androgen receptor pathway inhibitor switch, especially in patients having received abiraterone, is not that detrimental"

Real-world • Castration-Resistant Prostate Cancer

Cancer Vaccines: A Novel Revolutionized Approach to Cancer Therapy. (PubMed, Indian J Clin Biochem) - "In therapeutic vaccine only three are approved: Sipuleucel T-cell vaccine for treatment refractory prostatic cancer, BCG vaccine for early bladder cancer and T-VEC for inoperable melanoma. Heterogeneity within and between cancer types, screening and identifying suitable antigen specific to tumors and selection of vaccine delivery platforms are challenges in the development of vaccines. Adoptive cell therapy, Chimeric antigen receptor T cell therapy are recent breakthrough for cancer treatment."

Journal • Review • Bladder Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Infectious Disease • Melanoma • Oncology • Prostate Cancer • Solid Tumor

OU-SCC-EXCITE: Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=13 | Recruiting | Sponsor: University of Oklahoma | Trial completion date: Nov 2024 ➔ Dec 2026 | Trial primary completion date: Nov 2024 ➔ Jun 2026

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Real-world treatment patterns and survival in men with metastatic castration-resistant prostate cancer (mCRPC) who previously progressed from metastatic hormone-sensitive prostate cancer (mHSPC) between 2020 to 2023 in the United States. (ASCO-GU 2025) - "Background: While androgen deprivation therapy (ADT) is a backbone for managing mHSPC, therapies initially approved for mCRPC, such as androgen receptor pathways inhibitors like abiraterone (ABI) and non-ABI ARPIs ( enzalutamide, apalutamide, darolutamide), and/or docetaxel, are now guideline-recommended for use in mHSPC...Line of therapy was identified as ABI, non-ABI ARPI, taxane-based chemotherapy, poly (ADP-ribose) polymerase inhibitors (PARPIs), immunotherapy (pembrolizumab, sipuleucel-T), radiopharmaceuticals (Ra-223, 177Lu-PSMA-RLT), alone or in combination... With more than half of patients having received ADT alone in mHSPC, use of ARPIs was the most common 1L Tx option in mCRPC. Back-to-back use of ARPI upon progression to mCRPC was common. These findings highlight the need to explore alternative treatment option in mCRPC beyond ARPIs to improve survival in men with mCRPC."

Clinical • HEOR • Metastases • Real-world • Real-world evidence • Castration-Resistant Prostate Cancer • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Treatment (Rx) patterns and attrition rates in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2025) - "Background: The Rx landscape of pts with mCRPC has recently evolved with the approval of lutetium-177-PSMA-617 (Lu-177) and poly(ADP) ribose polymerase inhibitors (PARPi) either as single agents or as combinations with an androgen receptor pathway inhibitor (ARPI) [PMID: 37442702]...Androgen receptor pathway inhibitor (ARPI) was the most common Rx in the 1L setting (73.7%), followed by taxane (10%) and sipuleucel-T (3.8%)...In 3L, taxane became the most frequent Rx (35.4%), followed by ARPI (26.2%) and radium-223 (4.9%)... In the current era, a high proportion of pts with mCRPC receiving 1L Rx do not receive a subsequent line of Rx (39% of pts do not receive 2L, and 65% do not receive 3L Rx). ARPIs and taxanes remain the most frequently used Rx options in most L of therapy. These findings highlight the need for better tolerated Rx, therapies with a novel mechanism of action, and improved access to care for our pts."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Key Considerations for a Prostate Cancer mRNA Vaccine. (PubMed, Crit Rev Oncol Hematol) - "Sipuleucel-T was the first cancer vaccine approved by the FDA for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC), ushering in a new era of immunotherapy...The key components of mRNA vaccines include in vitro transcription, stability, and immunogenicity. Finally, strategies to circumvent in vivo mRNA degradation and approaches to optimise in vitro transcription (IVT) process are also discussed."

Journal • Review • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

The safety and efficacy study of Sipuleucel-T combined with platinum-based chemotherapy for neoadjuvant treatment in patients with locally advanced cervical cancer (multicenter). (ChiCTR) - P1 | N=33 | Sponsor: Fujian Medical University Union Hospital; Fujian Medical University Union Hospital

New P1 trial • Cervical Cancer • Oncology • Solid Tumor

Medication Prescription Policy for US Veterans With Metastatic Castration-Resistant Prostate Cancer: Causal Machine Learning Approach. (PubMed, JMIR Med Inform) - "This study of 2886 veterans showed evidence of heterogeneity and that survival days may be improved for certain patients with mCRPC based on the medication prescribed. Findings suggest that prescription rules based on the patient characteristics, laboratory test results, and comorbidities available to the physician at the time of prescription could improve survival by providing personalized treatment decisions."

Journal • Machine learning • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

The world's only approved prostate cancer cell immunotherapy is being tested in Beidaihe and is expected to be clinically transformed by the end of the year [Google translation] (Sina Corp) - "After introducing this innovative cell immunotherapy to China, Shwe China launched a Phase III pivotal registration clinical trial in 2023. So far, it has completed the single collection and transfusion of all 140 patients enrolled and entered the clinical observation period. Its safety and trial data showed positive efficacy and safety results, and it is expected to submit a marketing authorization application (BLA) in 2026....It is expected to have one product on the market by 2027."

China filing • Launch non-US • Trial status • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

The world's only approved prostate cancer cell immunotherapy is being tested in Beidaihe and is expected to be clinically transformed by the end of the year [Google translation] (Sina Corp) - "On November 25, the Beidaihe New District Management Committee and...Qinhuangdao First Hospital and Shanghai Danrui Biological...held a cooperation signing ceremony in Beidaihe New District...With the support of the national life and health industry '7+6' policy, and in accordance with the 'Guiding Principles for the Transformation and Application of Cell Therapy Technology in Beidaihe New Area' (Trial), the three parties will jointly promote the clinical application of the world's first FDA-approved cell immunotherapy product, Sipuleucel-T Injection (US trade name: Provenge), to be implemented in Beidaihe New Area as a 'first-come, first-served' project, so that the world's leading innovative drugs can benefit the vast number of domestic patients faster and earlier, filling the gap in cell immunotherapy in China's prostate cancer field....The project is expected to be put into operation and start treating patients before the end of the year."

Commercial • New trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Dose specific immune profile alterations of sipuleucel-T with potential clinical relevance in metastatic castrate-resistant prostate cancer (SITC 2024) - "The prevalence and phenotype of these subsets are likely to affect Sip-T's therapeutic efficacy. Thus, our studies deciphering these immune subsets may lead to optimization of combination immunotherapeutic strategies in mCRPC."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD4

Dose specific immune profile alterations of sipuleucel-T with potential clinical relevance in metastatic castrate-resistant prostate cancer (SITC 2024) - "The prevalence and phenotype of these subsets are likely to affect Sip-T's therapeutic efficacy. Thus, our studies deciphering these immune subsets may lead to optimization of combination immunotherapeutic strategies in mCRPC."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD4

Prostate Cancer, Pathophysiology and Recent Developments in Management: A Narrative Review. (PubMed, Curr Oncol Rep) - "Current treatments for M0 CRPCa include androgen deprivation therapy in combination with apalutamide, darolutamide or enzalutamide, all of which are associated with good metastatic-free survival rates in clinical trials. Hormone-naive metastatic prostate cancer comprises the same treatments as M0 CRPCa, whereas further treatment includes docetaxel and abiraterone. Metastatic castration-resistant prostate cancer treatments include sipuleucel-T, radium-223, abiraterone, enzalutamide and cabazitaxel, which aim to slow down the progression of the disease and to prolong life...In addition, new clinical trials are ongoing to test new medications such as cabozantinb and chimeric-antigen receptor T-cell therapy for the treatment of advanced prostate cancer. With the aim to slow down the progression of the disease and to prolong life, new drug developments are underway to hopefully provide a positive impact on overall survival and improve progression-free survival, especially in..."

Journal • Review • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Tuning TCR Immunotherapy Targeting Prostatic Acid Phosphatase via Catchbond Modifications for Advanced Prostate Cancer (PCF 2024) - "PAP was previously used to develop the first FDA-approved cancer vaccine, Provenge, but the specific epitopes and cognate TCRs were not clearly defined...Recent results have also demonstrated that further engineering with "catch bonds" on these candidate TCRs lead to dramatically improved cytotoxicity both in vitro and in vivo. This work demonstrated the feasibility of developing and enhancing TCRs targeting PAP for potential therapeutic usage."

IO biomarker • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ACPP • PSAP