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

Vaccines for Cancer: A Translational Science Review. (PubMed, JAMA) - "Sipuleucel-T, a vaccine against the antigen prostatic acid phosphatase, reduced all-cause mortality compared with placebo in men with metastatic castrate-resistant prostate cancer (32% vs 23%; hazard ratio, 0.78 [95% CI, 0.61-0.98]; P = .03). Compared with granulocyte-macrophage colony-stimulating factor, a systemic immune stimulant, talimogene laherparepvec increased rates of a 6-month or longer complete or partial response, defined as the disappearance of all treated disease and at least a 50% decrease in the sum of the products of perpendicular diameters of the measurable lesion with no new lesions, respectively, when injected into advanced melanoma lesions (16.3% [95% CI, 12.1%-20.5%] vs 2.1% [95% CI, 0%-4.5%]; odds ratio, 8.9; P < .001)...Combining the personalized mutation-based messenger RNA (mRNA) vaccine (mRNA-4157) with the immune checkpoint inhibitor pembrolizumab for resected high-risk stage IIIB to IV cutaneous melanoma improved relapse-free survival..."

IO biomarker • Journal • Bladder Cancer • Castration-Resistant Prostate Cancer • Cutaneous Melanoma • Fatigue • Genito-urinary Cancer • Hepatitis B • Infectious Disease • Melanoma • Oncology • Prostate Cancer • Solid Tumor • ACPP • PSAP

The Potential Role of Organ-to-Liver Ratios in Immune-Related FDG PET Imaging. Comment on Panikar et al. Exploratory FDG PET/CT Imaging in mCRPC Patients Treated with Sipuleucel-T ± IL-7: A Phase II Trial Subanalysis. Int. J. Mol. Sci. 2026, 27, 5129. (PubMed, Int J Mol Sci) - "We read with great interest the article by Panikar et al [...]."

Journal • P2 data • Castration-Resistant Prostate Cancer • Prostate Cancer • IL7

Comparative Pharmacovigilance Analysis of Safety Signals Among Advanced Prostate Cancer Therapies Using FAERS (FDA Adverse Event Reporting System). (PubMed, Curr Oncol) - "A retrospective pharmacovigilance study of FAERS reports evaluated enzalutamide, darolutamide, apalutamide, abiraterone acetate, relugolix, niraparib/abiraterone, talazoparib, rucaparib, cabazitaxel, sipuleucel-T, and lutetium-177 vipivotide. The absence of a detected signal should not be interpreted as evidence of safety or equivalence, as reporting volume, detection bias, and statistical power varied across therapies. Overall, the therapies demonstrated distinct toxicity profiles, which may inform treatment selection, toxicity monitoring, and patient counseling."

Adverse events • Clinical • Journal • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Hematological Disorders • Oncology • Prostate Cancer • Solid Tumor

Combined treatment with radium-223 (RAD) and enzalutamide (ENZ) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Insights from the global REASSURE study (ESMO 2025) - P, P3 | "Incidence of fractures was slightly higher in ALL pts (10%) with fewer pts receiving concomitant BPAs (denosumab 28% and zoledronic acid 13%)...Table: 2401P ENZ/RAD (N=45) ALL Pts (N=1,472) Median time since initial diagnosis of bone metastases to study entry, months 14 23 Median time since castration resistant cancer to study entry, months 7 13 Extent of disease, % Bone only metastases 80 81 Bone metastases + lymph node only 9 13 Disease burden, % 20 metastases but not Superscan 18 20 Superscan 4 6 Laboratory values, median ALP (U/L) 131 133 PSA (ng/mL) 33 59 Prior abiraterone, % 40 48 Prior docetaxel, % 16 39 Prior Sipuleucel-T, % 18 9 Conclusions In this subgroup of pts treated with combined ENZ/RAD in a real-world setting, there was no new safety signal...Pts received ENZ/RAD earlier in the disease course based on time from mCRPC, time from initial diagnosis of bone metastases and prior docetaxel. Fracture incidence was low in ENZ/RAD, and the majority of pts..."

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

Phase 3 trial of [177Lu]Lu-PSMA-617 in taxane-naive patients with metastatic castration-resistant prostate cancer (PSMAfore) (SNMMI 2024) - P3 | "Candidates for poly(ADP) ribose (PARP) inhibition and patients with prior systemic radiotherapy ( 12 months ago) were ineligible...4 GBq every 6 weeks for 6 cycles) or ARPI change (abiraterone or enzalutamide)... 177Lu-PSMA-617 prolonged rPFS, time to worsening in FACT-P total score and time to PSA progression, and improved ORR and PSA50 response, versus ARPI change in taxane-naive patients with PSMA-positive mCRPC, with a manageable safety profile."

Clinical • Metastases • P3 data • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • Xerostomia

Avelumab in Men With Metastatic Castration-Resistant Prostate Cancer, Enriched for Patients Treated Previously With a Therapeutic Cancer Vaccine. (PubMed, J Immunother) - "Therapeutic cancer vaccines including sipuleucel-T, a prostatic acid phosphatase (PAP) targeted vaccine that improves survival in metastatic castration-resistant prostate cancer (mCRPC), can produce immune responses that translate to clinical benefit...Eighteen patients enrolled, and previous treatments included abiraterone or enzalutamide in 14 (78%), therapeutic cancer vaccine in 14 (78%), and chemotherapy in 4 (22%)...Analysis of antigen-specific T-cell responses pre and postavelumab treatment did not demonstrate changes in interferon-γ production or proliferation in response to PAP or PA2024. This unplanned analysis does not support the use of sequential therapeutic cancer vaccine therapy followed by programmed death ligand-1 inhibition in mCRPC."

Journal • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ACPP • IFNG • PSAP

PSMAcTION trial-in-progress: a phase II/III randomized trial of [225Ac]Ac-PSMA-617 (225Ac-PSMA-617) versus standard of care in patients with PSMA-positive metastatic castration-resistant prostate cancer who progressed on or after [177Lu]Lu-PSMA therapy (ESMO 2025) - P2/3 | "Background Prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT) [ 177 Lu]Lu-PSMA-617 prolonged radiographic progression-free survival (rPFS) in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) in the taxane-naive (PSMAfore) and post-taxane (VISION) settings...In phase 3, ∼420 patients will be randomized to 225 Ac-PSMA-617 for ≤ 6 cycles or investigator's choice of SoC (excluding PARP inhibitors and immunotherapy except sipuleucel-T)...Safety follow-up will occur at 56 and 30 days (+7) after the last dose of 225 Ac-PSMA-617 and SoC, respectively, with long-term follow-up for up to 5 years. As of April 2025, the first patient first visit occurred in the Asia-Pacific region."

Clinical • Metastases • P2/3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Exploratory FDG PET/CT Imaging in mCRPC Patients Treated with Sipuleucel-T ± IL-7: A Phase II Trial Subanalysis. (PubMed, Int J Mol Sci) - P2 | "Metabolic changes in tumors and immune organs may provide insights into treatment-associated biological effects. Larger studies are warranted to validate these findings."

Journal • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • IL7

Phase III trial of [177Lu]Lu-PSMA-617 in taxane-naive patients with metastatic castration-resistant prostate cancer (PSMAfore) (ESMO 2023) - P3 | "Candidates for PARP inhibition and pts with prior systemic radiotherapy (12 months ago) were ineligible. Randomization was 1:1 to open-label 177Lu-PSMA-617 (7.4 GBq q6w; 6 cycles) or ARPI change (abiraterone/enzalutamide)...O. Sartor, M.J. Morris and K. Fizazi have equally contributed to the study."

Clinical • Late-breaking abstract • Metastases • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Dendritic cell‑based vaccines for colorectal cancer: Mechanisms, clinical progress and future directions (Review). (PubMed, Int J Oncol) - "The safety and effectiveness of DC‑based vaccines for cancer treatment have been demonstrated in several clinical studies, either as monotherapy (such as Sipuleucel‑T) or in combination with other therapies such as chemotherapy and immune checkpoint blockade...Additionally, the present review highlighted the outcomes of recent clinical trials of autologous DC‑based vaccines for advanced CRC, as well as the challenges and strategies for overcoming them in the development and clinical applications for CRC. Taken together, the potential and limitations of DC‑based vaccines for CRC are underscored in the present review to provide an improved understanding and guide future directions in developing efficacious DC‑based therapeutic vaccines for CRC."

Journal • Review • Colorectal Cancer • Developmental Disorders • Oncology • Solid Tumor

Immunotherapy in urological cancers: new paradigms and a systematic review of clinical trials and real-world evidence. (PubMed, Front Oncol) - "In bladder cancer, perioperative durvalumab and Enfortumab Vedotin (EV) plus pembrolizumab improved outcomes in MIBC, and the EV+pembrolizumab combination became a frontline standard for metastatic disease. Disitamab vedotin plus toripalimab improved outcomes in HER2-expressing tumours, and ctDNA-guided adjuvant atezolizumab introduces precision therapy for molecular residual disease...In prostate cancer, sipuleucel-T remains the first approved cancer vaccine, while newer trials explored ICIs (durvalumab+tremelimumab) and personalized peptide vaccines...Real-world evidence and immunoradiotherapy represents an emerging frontier, though optimal fractionation and sequencing require further investigation. Despite major advances, challenges remain in overcoming resistance, optimizing sequencing, and ensuring equitable access."

HEOR • IO biomarker • Journal • Real-world evidence • Review • Bladder Cancer • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Kidney Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Urethral Cancer • HER-2 • KIM1 • PD-L1

Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Washington University School of Medicine

New P1 trial • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Personalized cancer vaccines: bridging immune-oncology and precision medicine for advanced therapeutics. (PubMed, Signal Transduct Target Ther) - "Despite advancements in therapeutic cancer vaccines, clinical translation has been hindered by limited efficacy, with Sipuleucel-T remaining the only FDA-approved therapeutic cancer vaccine to date. However, recent advances in personalized mRNA vaccines, such as Moderna's mRNA-4157 and BioNTech's autogene cevumeran, have demonstrated significant reductions in recurrence risk and improved survival across several cancer types, renewing optimism in the field...Increasing clinical evidence, especially in melanoma and pancreatic cancer, underscores the potential of these strategies to induce long-term protection and reduce recurrence. Overall, next-generation personalized cancer vaccines are advancing the transition from reactive treatment to proactive, precision-controlled cancer immunotherapy."

Journal • Review • Melanoma • Oncology • Pancreatic Cancer • Solid Tumor

Clinical and genomic predictors of sipuleucel-T outcomes in men with metastatic androgen pathway modulator resistant prostate cancer. (PubMed, Res Sq) - "Aggressive tumor biology, immune evasion, and advanced disease state may underlie these inferior outcomes; alternative therapies should be considered in MYC-amplified mAPMR. Multicenter validation is planned to further enhance patient selection for sipuleucel-T."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • MYC • PTEN • TP53

Treatment Patterns and Attrition in Metastatic Castration-Resistant Prostate Cancer. (PubMed, JAMA Netw Open) - "First- through fifth-line treatment and attrition rates were summarized using frequencies and percentages into respective categories: androgen receptor pathway inhibitors (ARPIs), taxanes, poly (adenosine diphosphate-ribose) polymerase inhibitors (PARPIs), platinum-based therapies, lutetium Lu 177-prostate-specific membrane antigen 617 (Lu-177)-based therapies, radium Ra 223, sipuleucel-T, immunotherapy, and other. ARPIs and taxanes remained the most common first-line treatments, with increased use of Lu-177 and PARPIs in later treatment lines. These findings highlight the evolving complexity of mCRPC management and significant attrition with later lines, underscoring the need for optimized sequencing strategies, more efficacious frontline therapies, and interventions to improve access."

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

Cancer Vaccines in Genitourinary Malignancies: Current Advances and Future Directions. (PubMed, Vaccines (Basel)) - "Although agents such as bacillus Calmette-Guérin in bladder cancer and sipuleucel-T in prostate cancer have shown success, vaccine monotherapy has generally produced limited clinical benefit due to tumor heterogeneity, poor immune infiltration, and immunosuppressive tumor microenvironments...Advances in personalized vaccine design and delivery systems are driving progress, though challenges such as manufacturing complexity, cost, and biomarker development remain. Ongoing translational and clinical research will be critical to improving the effectiveness of vaccine-based immunotherapy in GU malignancies."

IO biomarker • Journal • Review • Bladder Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

Delayed PSA responses in metastatic castration resistant prostate cancer (mCRPC) patients (pts) treated with sipuleucel-T. (ASCO 2018) - "Twenty-three (41%) pts had received prior mCRPC directed therapy, of whom 5 had received prior abiraterone or enzalutamide. In this cohort of mCRPC pts who did not require immediate initiation of next line of therapy, vaccination with sipuleucel-T appeared to induce delayed PSA responses and modulate PSA kinetics in a subset of patients."

Clinical • Prostate Cancer

Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer (clinicaltrials.gov) - P2 | N=26 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Recruiting ➔ Active, not recruiting | Trial primary completion date: Oct 2026 ➔ Jul 2026

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

Harnessing Vaccines in the Treatment of Solid Tumors: Advances, Challenges, and Future Directions. (PubMed, Vaccines (Basel)) - "Currently, Sipuleucel-T for prostate cancer is the only cell-based vaccine that received FDA approval for the treatment of a solid tumor...Despite the current evidence of vaccine efficacy in treating solid tumors being derived from only a few clinical trials with relatively small sample sizes, ongoing trials are also exploring innovative approaches aimed at preventing cancer development or enhancing immune responses in combination with other immunotherapeutic agents. In this review, we provide an overview of the clinical results and the current state of vaccine development for cancer treatment, outlining future perspectives on their role in managing patients with cancer."

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

Phase II study of bipolar androgen therapy combined with sipuleucel-T for patients with metastatic castration resistant prostate cancer (mCRPC). (ASCO 2026) - P2 | "BAT demonstrated clinical activity in patients with metastatic castration resistant prostate cancer (mCPRC) progressing on abiraterone acetate (Denmeade S et al JCO 2021). BAT followed by sipuleucel-T is safe and effective in potentiating immune response to Sipuleucel-T. Encouraging clinical activity has been observed. The study is currently enrolling to the second stage of the Simon's design."

Clinical • Metastases • P2 data • Addiction (Opioid and Alcohol) • Castration-Resistant Prostate Cancer • CNS Disorders • Endocrine Disorders • Genito-urinary Cancer • Hepatocellular Cancer • Immunology • Oncology • Prostate Cancer • Solid Tumor • ACPP • CSF2 • IFNG • PSAP

OU-SCC-EXCITE: Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: University of Oklahoma | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2026 ➔ May 2028

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

Systemic Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer: ASCO Living Guideline, Version 2026.1 (ASCO.org) - "The Panel recommends either enzalutamide or chemotherapy using docetaxel for patients with visceral disease (lung and/or liver metastases) and regardless of homologous recombination repair (HRR) alterations (please refer to 1.1.1 and 1.1.2 for preferred recommendations in patients with HRR alterations...The panel recommends abiraterone with prednisone, darolutamide, apalutamide, or cabazitaxel in selected patients...The Panel recommends docetaxel, abiraterone plus prednisone, enzalutamide with radium 223, or sipuleucel-T for patients with mCRPC without visceral metastases...The Panel recommends using docetaxel chemotherapy, radium 223, or 177Lu-PSMA-617 (for patients with a prostate-specific membrane antigen [PSMA]–positive positron emission tomography scan) for patients regardless of HRR alterations."

Living guideline • Castration-Resistant Prostate Cancer

Novel immunotherapies for prostate cancer. (PubMed, Urol Oncol) - "Since the advent of the autologous dendritic cell-based vaccine, sipuleucel-T, in 2010, the clinical development of immunotherapeutic approaches in advanced prostate cancer has largely been lacking. Aside from the infrequent use of pembrolizumab immune checkpoint blockade in rare molecularly-selected patients, no further immune approaches have achieved regulatory approval...Nevertheless, recent advances in drug design and cellular engineering have reinvigorated interest in novel immunotherapeutic approaches in prostate cancer. This review provides an overview of the current landscape of novel immunotherapy clinical development for prostate cancer, with a focus on chimeric antigen receptor (CAR) T cells, T cell engagers, monoclonal antibodies, and cancer vaccine approaches that have produced promising early phase clinical data."

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

Assessment of the T cell receptor repertoire in racially diverse prostate cancer patients (AACR 2026) - "Interestingly, African American (AA) men respond far better to Sipuleucel-T and undergo different T cell responses than Caucasian American (CA) PCa patients... TCR-seq revealed significantly higher D50 scores in CA than AA tumors. We also found that men that developed biochemical recurrence and metastasis had significantly higher D50s than those that did not. Single cell V(D)J and RNA seq identified key differences in the TCR sequences of PBLs isolated from AA and CA PCa patients.Conclusions/future directions: These data may be used to help guide therapeutic options based on predicted responsiveness of an individual."

Clinical • IO biomarker • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Dendritic Cell-Based Immunotherapy for Solid Tumors. (PubMed, Surg Oncol Clin N Am) - "The only FDA-approved DC therapy, sipuleucel-T, increases survival in prostate cancer...Early-stage disease is an emerging target for DC therapy. Further research is needed to optimize these approaches."

Journal • Review • Genito-urinary Cancer • Hematological Malignancies • Melanoma • Oncology • Prostate Cancer • Solid Tumor