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

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

A Real-world Study of Characteristics, Treatment Patterns, and Clinical Outcomes Among Lutetium-177 Vipivotide Tetraxetan Treated Patients (clinicaltrials.gov) - P=N/A | N=1247 | Completed | Sponsor: Novartis Pharmaceuticals

New trial • Real-world evidence • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Real-world effectiveness of systemic therapies after 177Lu]Lu-PSMA-617 (177Lu-PSMA-617) treatment in patients with metastatic castration-resistant prostate cancer (mCRPC): A prostate cancer disease observation (PRECISION) data platform analysis. (ASCO-GU 2026) - "Systemic therapies included ARPIs (abiraterone, enzalutamide, darolutamide, apalutamide); chemotherapy (cabazitaxel, docetaxel, carboplatin, cisplatin, etoposide, mitoxantrone); immunotherapy (pembrolizumab, sipuleucel-T); poly (ADP-ribose) polymerase (PARP) inhibitors (niraparib, olaparib, talazoparib, rucaparib); and radium-223. In this real-world analysis, meaningful clinical responses were observed in a subset of patients who received subsequent systemic therapies after 177Lu-PSMA-617."

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

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

Treatment (Rx) patterns and attrition rates in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated between 2021-2025. (ASCO-GU 2026) - "Background: The Rx landscape for mCRPC has shifted significantly in recent years with the introduction of poly(ADP-ribose) polymerase inhibitors (PARPi) alone, PARPi in combination with androgen receptor pathway inhibitors (ARPIs), and 177Lu-PSMA-617 (Lu)...Rx was categorized into: ARPIs, taxane based therapies, PARPi-based therapies, platinum-based therapies, Lu-based therapies, radium-223, sipuleucel-T, immunotherapy, and other... In this large real-world mCRPC cohort, only about half of pts received 2L Rx, with attrition rising significantly across subsequent lines. ARPIs and taxanes remained the most common 1L Rx including 2025, with increased utilization of Lu and PARPi in later lines. These findings highlight the evolving complexity of mCRPC management and significant drop-off with later lines, underscoring the need for optimized sequencing strategies, more efficacious frontline therapies, and interventions to improve access."

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

Outcomes of 177Lu]Lu-PSMA-617 (177Lu-PSMA-617) after sipuleucel-T in patients with metastatic castration-resistant prostate cancer (mCRPC): A real-world prostate cancer disease observation (PRECISION) data platform analysis. (ASCO-GU 2026) - P3 | "In this real-world analysis of patients who received 177Lu-PSMA-617 after sipuleucel-T treatment, the median PFS was similar to that observed in clinical trials, suggesting that 177Lu‑PSMA-617 can be sequenced after sipuleucel-T treatment in appropriate patients."

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

Systemic Inflammatory Biomarkers and Lu-177-PSMA Radiopharmaceutical Therapy Response in Sipuleucel-T-Pretreated Metastatic Castration-Resistant Prostate Cancer (AACR-IO 2026) - "In this exploratory analysis, prior sipuleucel-T treatment was associated with higher biochemical response rates to 177Lu-PSMA-RPT, despite less favorable baseline inflammatory biomarkers. Additionally, pretreatment LDH demonstrated a trend toward positive correlation with PSA percent change in sipuleucel-T-treated patients but not in controls. Given the small sample size, retrospective design, and limited statistical power, prospective studies with larger cohorts and serial immune monitoring are warranted to validate the findings."

Biomarker • IO biomarker • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Patient-reported outcomes (PRO) from a dose-escalation and expansion trial of fractionated and multiple-cycle PSMA-targeted alpha radionuclide 225Ac-J591. (ASCO-GU 2026) - P1/2 | "Prior therapies: ≥2 ARPI in 32 (53%), chemotherapy in 43 (72%), radium-223 in 7 (12%), sipuleucel-T in 17 (34%), and 177Lu-PSMA in 11 (18%). 225Ac-J591 was well tolerated with preserved HRQoL, particularly in the fractionated regimen. FACT-P demonstrated maintained or modest improvement in QoL, while FACT-RNT confirmed stability of treatment-related symptom burden across dose levels. Together, these results suggest that 225Ac-J591 preserves quality of life during therapy without significant physical or emotional decline."

Clinical • Patient reported outcomes • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Clinical and genomic predictors of sipuleucel-T (sip-T) outcomes in men with metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2026) - "Among men with mCRPC treated with sip-T, MYC and AR gain had strong and significant independent associations with rapid post-treatment progression and poor OS. Lack of anemia, good PS, longer time since diagnosis, and no detectable genetic alterations associated with improved OS, consistent with prior studies of other mCRPC therapies. Rapid tumor proliferation and progression likely explain inferior outcomes and limited benefits, and concurrent or alternative therapies should be considered."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CDK12 • PTEN • RB1 • TP53

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 primary completion date: Dec 2025 ➔ Oct 2026

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

Chemotherapy-Forward Management of Advanced Prostate Cancer: Taxane Timing, Sequencing and the Real-World Place of Immunotherapy. (PubMed, Cancers (Basel)) - "In mCRPC, docetaxel remains foundational, while cabazitaxel is preferred over ARPI switching after prior docetaxel and one ARPI, supporting mechanism-based sequencing. Immunotherapy has a limited but important niche: sipuleucel-T may benefit selected patients with low symptom burden, whereas immune checkpoint inhibitors are best reserved for biomarker-defined subsets such as microsatellite instability-high or mismatch repair-deficient tumors; tumor mutational burden should be interpreted cautiously in prostate cancer. Ongoing trials and emerging antigen-directed platforms will clarify whether chemotherapy can act as an immune-enabling partner in defined settings."

IO biomarker • Journal • Real-world evidence • Review • Tumor mutational burden • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Hormone Sensitive Prostate Cancer • Microsatellite Instability • Neutropenia • Oncology • Prostate Cancer • Solid Tumor • MSI • TMB

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

Therapeutic vaccination for active induction of T cell immunity against cancer, ready for a rich harvest after 40 years. (PubMed, J Immunother Cancer) - "Only two therapeutic vaccines for neoplastic disease were approved by the Food and Drug Administration in the past 40 years: sipuleucel-T, approved in 2010 for hormone-resistant metastatic prostate cancer and targeting prostate acid phosphatase; and zopapogene imadenovec, approved in 2025 for recurrent respiratory papillomatosis, a rare, non-malignant but often invalidating disease caused by human papillomavirus (HPV) type 6 or type 11. In another randomized study, patients with R/M HPV16+ head and neck cancer only benefited from the combination of HPV16-specific SLP vaccine and a PD-1 blocker if they had high pretreatment PD-L1 biomarker expression in cancer tissue. Increasingly, biomarker-guided therapy is recommended."

IO biomarker • Journal • Review • Cervical Cancer • Colonic Polyps • Gastroenterology • Genito-urinary Cancer • Head and Neck Cancer • Melanoma • Oncology • Prostate Cancer • Solid Tumor

Price transparency & out-of-pocket payments for medications: Implications of associated delivery fees in the United States. (PubMed, Health Policy Open) - "Using the IBM Marketscan databases, we identify male patients who initiated treatment with one of six focus drugs (docetaxel, abiraterone, enzalutamide, sipuleucel-T, cabazitaxel, and radium-223) used to treat mCRPC from 07/01/2013-06/30/2019. These analyses suggest that when accounting for additional services required on the day of drug receipt, the amount a patient pays to receive a medication for mCRPC can be very different from the OOP payment for the drug alone; these payments also vary by drug and health plan type. Therefore, price transparency for drug alone may not lead to reduced OOP payments for patients."

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

Unveiling the hidden cardiovascular risk of sipuleucel-T: a pharmacovigilance analysis using the FDA Adverse Event Reporting System, 2010-2025. (PubMed, Front Immunol) - "Additionally, age ≥ 75 years, body weight ≥ 75 kg, and concomitant use of ≥5 medications were identified as independent risk factors for sipuleucel-T-related CVAEs (p < 0.001). This study characterizes the clinical spectrum, time-to-onset patterns, and risk factors of sipuleucel-T-associated CVAEs, providing essential pharmacovigilance data for managing patients with mCRPC."

Adverse events • Journal • Retrospective data • Cardiovascular • Castration-Resistant Prostate Cancer • Congestive Heart Failure • Genito-urinary Cancer • Heart Failure • Hypertension • Myocardial Infarction • 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

177^Lu-PSMA-617 in Combination With Sipuleucel-T for the Treatment of Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: City of Hope Medical Center | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2027 ➔ Jul 2028 | Initiation date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Jun 2027 ➔ Jul 2028

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • ACPP • PSAP

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

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

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

Cellular Immunotherapy for Prostate Cancer: Lessons Learned From 15 Years of Sipuleucel-T. (PubMed, Prostate Cancer) - "Despite the addition of multiple life-prolonging therapeutic modalities now available to treat patients with mCRPC, the mechanism of action of sipuleucel-T remains unique for patients with advanced prostate cancer. Therefore, maximizing the appropriate clinical utilization of sipuleucel-T in patients with mCRPC within current treatment paradigms is essential."

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

Synergistic potential of sipuleucel-T in enhancing immunotherapy for metastatic castration-resistant prostate cancer. (PubMed, J Immunother Cancer) - "Given the use of sipuleucel-T as a standard of care backbone, there is emerging interest in combining it with other immunotherapies, hormonal therapies, or chemotherapies to improve its clinical efficacy. This review summarizes past experiences and current knowledge of combining sipuleucel-T with other treatments and explores future approaches to enhance such combinatorial strategies."

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

Real-World Treatment Patterns and Survival in Metastatic Castration-resistant Prostate Cancer: A Systematic Review of Observational Studies. (PubMed, Eur Urol Focus) - "The findings showed that ARPIs are the most frequent first- and second-line treatments in mCRPC, and back-to-back ARPI sequencing is also common practice, especially in the USA, despite the availability of therapies beyond ARPIs. The findings highlight the need to optimize treatment beyond systemic hormone therapy in this setting."

HEOR • Journal • Observational data • Real-world evidence • Review • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

The landscape of genitourinary cancer vaccines: clinical advances and future opportunities. (PubMed, J Adv Res) - "Therapeutic cancer vaccines have been proven effective in the treatment of genitourinary cancers, such as Sipuleucel-T (Provenge) and Bacillus Calmette-Guérin (BCG)...Through different platforms (peptides, DNA, RNA, dendritic cells, etc.), therapeutic cancer vaccines can provoke or strengthen anti-tumor immunity with the assistance of cytokines, chemokines as well as other adjuvants to therefore prevent the deterioration of cancer and eradicate tumor cells. Only a limited number of therapeutic genitourinary cancer vaccines have received regulatory approval, indicating that there are still many critical challenges for the clinical translation of cancer vaccines, which mainly focus on finding effective antigens, immunogenic platforms and suitable combinational clinical strategies."

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

Vascular and neurological toxicity profile of Sipuleucel-T: a large-scale real world pharmacovigilance study. (PubMed, Int J Surg) - "The neurological toxicity of Sipuleucel-T is relatively modest. Age (70-80 years) and body weight were identified as independent predictors of cerebrovascular events during treatment, with higher body weight showing a protective effect. This study identifies high-risk population characteristics for Sipuleucel-T-associated cerebrovascular events, providing important data to support clinical safety measures."

Adverse events • Journal • Real-world evidence • Atrial Fibrillation • Cardiovascular • Hematological Disorders • Myocardial Infarction • Thrombosis