AiRuiEn (rezvilutamide) / Jiangsu Hengrui Pharma - LARVOL DELTA

A phase II study combining ADT, novel androgen receptor inhibitors, prostate cryoablation, and metronomic cyclophosphamide for patients with newly diagnosed, metastatic prostate cancer (ESMO 2025) - P2 | "Eligible participants will receive ADT in combination with one of the following nARIs (enzalutamide, apalutamide, darolutamide, rezvilutamide), initiated within three months of ADT commencement. Legal entity responsible for the study Sun Yat-sen University Cancer Center. Funding Jiangsu Hengrui Pharmaceuticals Co., Ltd."

Clinical • Metastases • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Evaluating treatment efficacy in metastatic hormone-sensitive prostate cancer with visceral disease: A systematic review and network meta-analysis (ESMO 2025) - "ADT + Docetaxel + Darolutamide emerged as the most effective regimen (HR 0.42; 95% CI: 0.21-0.82), followed by ADT + Docetaxel (HR 0.53; 95% CI: 0.30-0.93) and ADT + Abiraterone (HR 0.58; 95% CI: 0.41-0.83). Conversely, ARPI-based doublets with Enzalutamide, Apalutamide, Darolutamide and Rezvilutamide showed modest efficacy...These findings provide crucial evidence to the current clinical decision-making and highlight the need for VD-specific clinical trials to further optimize treatment strategy. Legal entity responsible for the study The Authors."

Metastases • Retrospective data • Review • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Rezvilutamide (REZ) in combination with androgen-deprivation therapy (ADT) for prostate cancer patients with biochemical recurrence (BCR) post radical prostatectomy (RP): preliminary results from a phase II trial (ESMO 2025) - P2 | "Conclusions The combination of REZ and ADT manifested the ability to achieve and sustain an undetectable PSA level over 12 months in the specific population of BCR. Ongoing follow-up is in progress to comprehensively assess the long-term efficacy and safety."

Clinical • Combination therapy • P2 data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

The efficacy of rezvilutamide (Rez) plus androgen-deprivation therapy (ADT) in patients (pts) with high-volume, nonvisceral metastatic hormone-sensitive prostate cancer (HSPC): A post hoc analysis of CHART study (ESMO 2025) - P3 | "Compared with bicalutamide (Bic), Rez + ADT improved radiographic progression-free survival (rPFS) and overall survival (OS). Table: 2434P R group (mos) B group (mos) P value HR (95% CI) mrPFS ≤10 NR NR 0.013 0.46 (0.25–0.86) 11-20 NR 22.4 0.009 0.46 (0.25-0.83) >20 NR 15.7 20 NR 36.2 0.005 0.56 (0.38-0.85) Conclusions This analysis showed that, compared with Bic, Rez + ADT showed improved survival benefit in pts with nonvisceral metastatic HSPC, regardless of the number of bone metastases. Legal entity responsible for the study The authors."

Clinical • Metastases • Retrospective data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Real-world multicenter study of rezvilutamide plus androgen deprivation therapy in Chinese patients with high-volume metastatic hormone-sensitive prostate cancer. (PubMed, Front Oncol) - "Rezvilutamide plus ADT provides rapid and profound PSA responses with a favorable safety profile in real-world Chinese patients with high-volume mHSPC. Baseline PSA serves as an important predictor for short-term biochemical response, supporting its clinical value as a standard first-line therapy."

Clinical • Journal • Real-world evidence • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Novel hormone therapies for advanced prostate cancer: Understanding and countering drug resistance. (PubMed, J Pharm Anal) - "This review offers a comprehensive overview of NHT, including abiraterone, enzalutamide, apalutamide, darolutamide, and rezvilutamide, which have demonstrated efficacy in delaying disease progression and improving patient survival and quality of life. Additionally, advanced sequencing technologies and resistance research models should be leveraged to identify novel therapeutic targets and improve drug delivery efficiencies. These advancements hold the potential to overcome NHT resistance and significantly enhance the management and prognosis of patients with advanced prostate cancer."

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

RWS-GU001: Real-world Study on Preoperative Application of Rezvilutamide (clinicaltrials.gov) - P=N/A | N=115 | Not yet recruiting | Sponsor: Shanghai Pudong New Area Gongli Hospital

New trial • Real-world evidence

Real-World Multicenter Study of Rezvilutamide Plus Androgen Deprivation Therapy in Chinese Patients with High-Volume Metastatic Hormone-Sensitive Prostate Cancer (Front Oncol) - "A total of 236 patients with high-volume mHSPC were enrolled....The rates of achieving PSA50, PSA90, and PSA ≤0.2 ng/mL at 3 months were 99.15%, 88.98%, and 39.41%, respectively....Multivariable analysis further indicated that baseline PSA showed a trend toward being an independent predictor for achieving PSA ≤0.2 ng/mL (P=0.063)."

Retrospective data • Hormone Sensitive Prostate Cancer

Clinical Study of Rezvilutamide Combined With Docetaxel Chemotherapy in the Treatment of Abiraterone-Resistant Prostate Cancer (clinicaltrials.gov) - P=N/A | N=20 | Enrolling by invitation | Sponsor: Zhujiang Hospital

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

An open-label, parallel-cohort, multicenter clinical study of Rezvilutamide in combination with androgen deprivation therapy (ADT) with or without docetaxel in the neoadjuvant treatment of oligometastatic prostate cancer (ChiCTR) - P4 | N=100 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Wenzhou Medical University | Initiation date: Dec 2024 ➔ Apr 2025

Trial initiation date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Exploratory Study of Rezvilutamide Combined with ADT as Neoadjuvant Therapy for Patients with Locally Advanced Prostate Cancer (ChiCTR) - P4 | N=68 | Not yet recruiting | Sponsor: The First Affiliated Hospital of AFMU (Xijing Hospital); The First Affiliated Hospital of AFMU (Xijing Hospital)

New P4 trial • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Treatment-related pure large-cell neuroendocrine carcinoma of the prostate with systemic metastases in a young adult: a rare case report. (PubMed, Front Oncol) - "After receiving 12 months of goserelin acetate, rezvilutamide and six cycles of docetaxel, the patient further underwent laparoscopic radical prostatectomy (LRP)...Subsequently, the patient then received immunotherapy with serplulimab (300 mg) and the EP regimen (combining etoposide and cisplatin) chemotherapy...Here we reported a rare case of treatment-related LCNEPC, who had experienced systematic therapy with comprehensive care. These diagnostic and therapeutic approaches may improve the management capability and highlight the critical role of multimodal strategies in the subsequent cases."

Journal • Endocrine Cancer • Genito-urinary Cancer • Genitourinary Neuroendocrine Carcinoma • Neuroendocrine Carcinoma • Oncology • Pain • Prostate Cancer • Solid Tumor

A Study of SHR3680 in Combination With SHR3162 in the Treatment of mCRPC (clinicaltrials.gov) - P2 | N=20 | Terminated | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | N=144 ➔ 20 | Active, not recruiting ➔ Terminated; The sponsor's R&D strategy is adjusted.

Enrollment change • Trial termination • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Cost-effectiveness analysis of rezvilutamide versus bicalutamide and androgen-deprivation therapy in patients with high-volume, metastatic, hormone-sensitive prostate cancer: a Markov's model-based evaluation. (PubMed, Front Public Health) - "Scenario analysis indicated that rezvilutamide could be considered cost-effective if priced below $705.46 per cycle. From the perspective of Chinese payers, rezvilutamide plus ADT appears to be a less cost-effective strategy compared to bicalutamide plus ADT for the first-line treatment of high-volume mHSPC in China."

HEOR • Journal • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Efficacy of triplet therapy based on organoid drug sensitivity testing in lung metastatic hormone-sensitive prostate cancer. (ASCO 2025) - "The triple regimen of goserelin acetate extended-release microspheres in combination with rezvilutamide and docetaxel demonstrated encouraging outcomes in HSPC with lung metastasis. The construction of organoid and drug sensitivity assays holds great potential in facilitating more precise screening of suitable treatment regimens for individual patients."

Clinical • Metastases • Anemia • Constipation • Gastric Cancer • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Musculoskeletal Pain • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor

A multicenter real-world study on the treatment of prostate cancer with Rezvilutamide Tablets (ChiCTR) - P4 | N=500 | Not yet recruiting | Sponsor: QingHai University Affiliated Hospital; QingHai University Affiliated Hospital

New P4 trial • Real-world evidence • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing (clinicaltrials.gov) - P2 | N=88 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2026 ➔ Dec 2026 | Trial primary completion date: Sep 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Oncology • Salivary Gland Cancer • AR • HER-2

Real-world effectiveness of rezvilutamide plus androgen deprivation therapy in patients with low-volume, metastatic hormone-sensitive prostate cancer: a retrospective multicenter study. (PubMed, Transl Androl Urol) - "In a real-world clinical setting, the combination of rezvilutamide and ADT demonstrated favorable PSA response in this patient population. These findings provide additional treatment options for patients with low-volume mHSPC and support the need for further large-scale research on rezvilutamide in this subgroup."

Clinical • Journal • Real-world evidence • Retrospective data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Real world research on Rezvilutamide (ChiCTR) - P=N/A | N=112 | Not yet recruiting | Sponsor: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

New trial • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer (SEGNO): study protocol for an open-label prospective phase II umbrella clinical trial. (PubMed, BMC Cancer) - P2 | "SEGNO, to the best of our knowledge, is the first umbrella clinical trial designed to provide high-level evidence to support the implementation of genomic biomarker-guided neoadjuvant therapy for locally advanced PCa and OMPCa."

Biomarker • Clinical protocol • Journal • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

The Predictive Role of the Gleason Score in Determining Prognosis to Systematic Treatment in Metastatic Castration-Sensitive Prostate Cancer: A Systematic Review and Network Meta-Analysis. (PubMed, J Clin Med) - "In the overall population, most ARSI combination therapies improved survival outcomes, except for orteronel + androgen deprivation therapy (ADT). In the Gleason score ≥8 subgroup, all ARSI combination therapies improved OS, with rezvilutamide showing the highest probability of being the best treatment for OS (HR 0.48, 95% CI 0.31-0.76, P-scores 0.88). In the Gleason score <8 subgroup, only darolutamide + docetaxel + ADT (HR 0.49, 95% CI 0.29-0.81) and apalutamide + ADT (HR 0.67, 95% CI 0.46-0.98) improved OS. ARSI combination therapy is effective for mCSPC patients with Gleason score ≥8, but further investigation is needed to confirm its efficacy in patients with Gleason score <8."

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

Exploration of Treatment Effect of Novel Hormone Therapy Combined with Local Treatment Based on PSMA PET/CT Evaluation in MHSCP Patients (clinicaltrials.gov) - P2 | N=192 | Not yet recruiting | Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

On-treatment PSA kinetics as a potential biomarker: Guiding personalized treatment in metastatic hormone-sensitive prostate cancer. (PubMed, Med) - "present a post-hoc analysis of the phase 3 CHART trial investigating rezvilutamide in the metastatic hormone-sensitive prostate cancer setting.1 They show that patients achieving a deep PSA response at six months had significantly improved outcomes. These findings could impact patient counseling and support the potential role of on-treatment PSA kinetics in personalizing therapy."

Biomarker • Journal • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A randomized, parallel-cohort, multicenter clinical study of Rezvilutamide in combination with androgen deprivation therapy (ADT) with or without docetaxel in the neoadjuvant treatment of oligometastatic prostate cancer (ChiCTR) - P4 | N=100 | Sponsor: The First Affiliated Hospital of Wenzhou Medical University; The First Affiliated Hospital of Wenzhou Medical University

New P4 trial • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

RAANTPC: An exploratory study of rivalutamide combined with ADT and abiraterone neoadjuvant therapy in patients with localized high-risk or locally advanced prostate cancer (ChiCTR) - P4 | N=76 | Recruiting | Sponsor: The First Affiliated Hospital of the Air Force Medical University; The First Affiliated Hospital of the Air Force Medical University

New P4 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor