AiRuiEn (rezvilutamide) / Jiangsu Hengrui Pharma - LARVOL DELTA

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

The post-analysis results of Hengrui's innovative drug rezvilutamide for the treatment of prostate cancer were published in the Nature journal STTT [Google translation] (Jiangsu Hengrui Press Release) - P3 | N=654 | CHART (NCT03520478) | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | "Patients who received rezvilutamide plus ADT had a longer median time to worst pain progression compared with those in the control group (NR [95% CI: NR-NR] vs. NR [95% CI: 20.3-NR]; 25th percentile: 9.2 months [95% CI: 7.4-16.6] vs. 6.4 months [95% CI: 5.5-8.3]; HR=0.75 [95% CI: 0.57-0.97]; p=0.026. The median time to pain intervention was longer in the rezvilutamide + ADT group (NR [95% CI: NR-NR] vs. NR [95% CI: NR-NR]; 25th percentile: 20.2 months [95% CI: 12.9-31.3] vs. 10.2 months [95% CI: 7.4-11.1]; HR=0.70 [95% CI: 0.52-0.93]; p=0.015. The median to mean time to pain progression was not reached in either group, with the 25th percentile being 25.8 months (95% CI: 14.8-31.4) in the rezvilutamide + ADT group and 11.7 months in the control group (95% CI: 8.7-22.1; HR = 0.79 [95% CI: 0.58-1.08]; p = 0.133."

P3 data • Prostate Cancer

Patient-reported outcomes of rezvilutamide versus bicalutamide in combination with androgen deprivation therapy in high-volume metastatic hormone-sensitive prostate cancer patients (CHART): a randomized, phase 3 study. (PubMed, Signal Transduct Target Ther) - P3 | "Additionally, the REZ-ADT group demonstrated a prolonged delay in the deterioration of the total score on the FACT-P questionnaire (25th percentile, 12.8 [95% CI 7.4-20.3] vs. 6.0 months [95% CI 4.6-9.2]; HR 0.66 [95% CI 0.50-0.86]; p = 0.002), as well as most of the FACT-P subscale scores, in comparison to the BIC-ADT group. In conclusion, REZ-ADT is superior to BIC-ADT regarding the pain alleviation and enhancement of functional scales for high-volume mHSPC."

Clinical • Combination therapy • Journal • Metastases • P3 data • Patient reported outcomes • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Pain • Prostate Cancer • Solid Tumor

2024 ESMO ASIA Oral Report│Hengrui’s innovative drug rezvilutamide in the treatment of metastatic hormone-sensitive prostate cancer: Post hoc analysis results for different age subgroups [Google translation] (Jiangsu Hengrui Press Release) - P3 | N=654 | CHART (NCT03520478) | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | "The study included 654 prostate cancer patients with ECOG score 0 or 1, high tumor burden, and no previous ADT, chemotherapy, surgery or local treatment....In all three age groups (≤64 years, 65-74 years, and ≥75 years), the rezvilutamide + ADT group improved patients' rPFS and overall survival (OS) compared with the control group, including in elderly patients with poor health status (≥75 years and ECOG performance status of 1)....The rezvilutamide plus ADT group was also superior to the control group in delaying PSA progression in all 3 age groups (≤64 years, 65-74 years, and ≥75 years) and in older patients with poor health status (≥75 years and ECOG performance status of 1)....Regardless of the age subgroup, the PSA undetectable rate in the rezvilutamide + ADT group was higher than that in the control group..."

P3 data • Prostate Cancer

Adjuvant rezvilutamide in combination with androgen-deprivation therapy, with or without radiotherapy, in high-risk patients following radical prostatectomy: A multi-center, open-label, two-cohort exploratory study (ESMO Asia 2024) - P4 | "Secondary endpoints include bPFS, 4-year metastasis-free survival (MFS) rate, time to testosterone recovery, and testosterone recovery rate, and exploratory endpoints include safety profiles, overall quality of life, and the exploration of the relationship between efficacy, safety, and biomarkers. Enrollment is ongoing."

Clinical • Combination therapy • Oncology • Prostate Cancer

Rezvilutamide plus androgen deprivation therapy in patients with low-volume, metastatic hormone-sensitive prostate cancer: A national, real-world cohort study (ESMO Asia 2024) - P4 | "Table: 340P Subgroup analysis of efficacy by 3 months Characteristics PSA50 PSA90 Undetectable PSA Age, years, n /N (%) < 75 81/86 (94.2) 77/86 (89.5) 53/86 (61.6) ≥ 75 47/52 (90.4) 44/52 (84.6) 25/52 (48.1) ECOG PS, n /N (%) 0-1 103/110 (93.6) 96/110 (87.3) 62/110 (56.4) ≥ 2 20/23 (87.0) 20/23 (87.0) 13/23 (56.5) Baseline testosterone, ng/dL, n /N (%) < 50 23/27 (85.2) 21/27 (77.8) 16/27 (59.3) ≥ 50 19/20 (95.0) 18/20 (90.0) 12/20 (60.0) Gleason score, n /N (%) < 8 27/29 (93.1) 25/29 (86.2) 16/29 (55.2) ≥ 8 59/63 (93.7) 58/63 (92.1) 35/63 (55.6) Prior ADT therapy, n /N (%) 13/14 (92.9) 12/14 (85.7) 11/14 (78.6) Conclusions Rezvilutamide plus ADT yielded a promising PSA response in pts with low-volume mHSPC in a real-world setting. This study represents the first evaluation of rezvilutamide in low-volume population."

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

Efficacy and safety of rezvilutamide (Rez) plus androgen-deprivation therapy (ADT) in patients with high-volume, metastatic, hormone-sensitive prostate cancer (mHSPC) aged ≤64, 65–74, and ≥75 years: Post-hoc analysis of randomized phase III CHART trial (ESMO Asia 2024) - P3 | "Background The CHART trial demonstrated that Rez + ADT significantly improved radiographic PFS (rPFS) and OS compared with bicalutamide (Bic) + ADT in high-volume mHSPC (Gu et al., Lancet Oncol , 2022). The between-group difference was calculated as the PSA undetectable rate of Rez+ADT minus Bic+ADT. Conclusions Rez + ADT was effective and well-tolerated in patients with mHSPC across all age groups, supporting its use as a treatment option for high-volume mHSPC, regardless of age."

Clinical • Metastases • P3 data • Retrospective data • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Case report: Synchronous prostate cancer and renal cell carcinoma with prostate cancer-origin metastases to adrenal and renal hilar lymph nodes. (PubMed, Front Oncol) - "Ultimately, the patient with metastatic hormone-sensitive prostate cancer (mHSPC) received combination therapy with rezvilutamide and goserelin, which resulted in a satisfactory treatment response. In patients with concurrent PCa and RCC, metastatic lesions in the adrenal glands, renal hilar, and retroperitoneal lymph nodes may also originate from the PCa. Accurate identification of the primary tumor and proper staging are critical for the appropriate management of patients with multiple primary malignancies with concurrent metastases."

Journal • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor

Correlation of PSA and survival in metastatic hormone-sensitive prostate cancer treated with rezvilutamide plus ADT in the CHART trial. (PubMed, Med) - P3 | "PSA kinetics is a valuable prognostic factor in mHSPC treated with rezvilutamide plus ADT, and the achievement of undetectable PSA and PSA90 is associated with improved survival. These findings highlight the importance of monitoring PSA kinetics in the management of mHSPC."

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

SEGNO: An exploratory study of the safety and efficacy of genomic biomarker-guided neoadjuvant therapy for locally advanced and oligometastatic prostate cancer (ESMO 2024) - P2 | "According to the results of the genomic profile, participants (N = 40) will be assigned to 4 NT groups: Arm 1: Homologous recombination repair (HRR) alterations (BRCA1/2) (Rezvilutamide: 240 mg PO QD + goserelin microspheres: 3.6 mg IM Q4W + parmiparib: 60 mg PO QD); Arm 2: HRR alterations (except BRCA1/2 and CDK12) (Rezvilutamide: 240 mg PO QD + goserelin microspheres: 3.6 mg IM Q4W + cisplatin: 70 mg/m2 IV Q3W); Arm 3: MSI-H/dMMR, TMB≥10 mut/Mb or CDK12 alterations without other HRR alterations (Rezvilutamide: 240 mg PO QD + goserelin microspheres: 3.6 mg IM Q4W + tislelizumab: 200 mg IV Q3W); Arm 4: No targetable actionable aberration (Rezvilutamide: 240 mg PO QD + goserelin microspheres: 3.6 mg IM Q4W + docetaxel: 70 mg/m2 IV Q3W). The primary endpoints are rates of clinical complete response, pathological minimal residual disease (defined as residual tumor 5 mm or less) and complete pathologic response. Secondary endpoints include overall survival,..."

Biomarker • Clinical • Metastases • Tumor mutational burden • Genito-urinary Cancer • Microsatellite Instability • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • CDK12 • HRD • MSI

Impact of concomitant medications on safety in patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC) receiving rezvilutamide (Rez) plus androgen-deprivation therapy (ADT): A post-hoc analysis of the randomized phase III CHART trial (ESMO 2024) - P3 | "Background: The CHART trial demonstrated significant improvements in radiographic PFS and OS with Rez + ADT compared to bicalutamide (Bic) + ADT in high-volume mHSPC (Gu et al., Lancet Oncol 2022). The concomitant use of antithrombotics, gastric acid disorder-related drugs, and lipid-modifying drugs during Rez + ADT treatment has either no or minimal impact on the safety profile of patients with high-volume mHSPC, supporting the safe use of these concomitant medications when clinically indicated."

Clinical • Metastases • P3 data • Retrospective data • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

2024 ESMO︱Hengrui’s innovative drug rezviluamide CHART study announces analysis of the impact of combined medication on safety [Google translation] (Jiangsu Hengrui Press Release) - P3 | N=654 | CHART (NCT03520478) | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | "In patients with high tumor burden mHSPC who were also receiving antithrombotic drugs, gastric acid disorder treatment drugs, or lipid-regulating drugs, the incidence of toxicity in the rezvilutamide + ADT group was comparable to or slightly higher than that in the control drug + ADT group. This may be partly due to the longer exposure time of rezvilutamide + ADT treatment than that of control drug + ADT treatment (1.8-2.0 times). Longer medication duration may be associated with better survival benefits such as rPFS."

P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

The Impact of Medication Timing Adjustment on the Effect of Novel Hormonal Therapy (clinicaltrials.gov) - P2 | N=70 | Not yet recruiting | Sponsor: Sun Yat-sen University

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