Delving into the Latest Updates on Rezvilutamide with Synapse

Author: Bian, Xiaojie ; Ye, Dingwei ; Gu, Weijie ; Wang, Qilin ; He, Chaohong ; Shi, Benkang ; Han, Bangmin ; Yang, Xinfeng ; Xing, Jinchun ; Xia, Shujie ; Xu, Zhuoqun ; Zhang, Xuepei ; Sun, Ting ; Xu, Danfeng ; Xie, Liping ; Wang, Shaogang ; Wang, Wenliang ; Du, Chuanjun ; Wei, Shaozhong ; Zhang, Dahong ; Lian, Jianpo ; Weng, Zhiliang

BACKGROUNDThis exploratory analysis of the CHART trial (ClinicalTrials.gov: NCT03520478) investigated prostate-specific antigen (PSA) kinetics and the correlation between PSA and survival outcomes in high-volume, metastatic, hormone-sensitive prostate cancer (mHSPC).METHODSA total of 654 patients were randomized 1:1 to receive either rezvilutamide plus androgen deprivation therapy (ADT; n = 326) or bicalutamide plus ADT (n = 328). PSA kinetics were evaluated, and the correlation between survival and the achievement of undetectable PSA (≤0.2 ng/mL) or ≥90% PSA reduction (PSA90) was assessed.FINDINGSThe rezvilutamide group exhibited higher proportions of ≥50% PSA reduction (PSA50; 98.2% vs. 87.5%), PSA90 (88.7% vs. 63.1%), and undetectable PSA (38.3% vs. 17.7%) responses compared to the bicalutamide group by 3 months. The rezvilutamide group demonstrated superior efficacy in delaying PSA progression compared to the bicalutamide group (hazard ratio [HR] 0.21, 95% confidence interval 0.16-0.27). The achievement of undetectable PSA and PSA90 by 6 months in the rezvilutamide group was associated with prolonged overall survival (undetectable PSA, HR = 0.34; PSA90, HR = 0.22), radiographic progression-free survival (HR = 0.36, HR = 0.26), time to PSA progression (HR = 0.25, HR = 0.17), and time to castration resistance (HR = 0.34, HR = 0.23) compared to those who did not achieve these PSA milestones. Stratification by baseline PSA level revealed consistent survival improvements with rezvilutamide plus ADT across quartiles.CONCLUSIONSPSA 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.FUNDINGThis study was funded by Jiangsu Hengrui Pharmaceuticals Co., Ltd.

01 Jul 2024·BMJ Open

Cost-effectiveness analysis of rezvilutamide versus bicalutamide in the treatment of metastatic hormone-sensitive prostate cancer

Article

Author: Zhan, ZhaJun ; Fang, Luo ; Xu, Xinglu ; Ding, Haiying ; He, Chaoneng ; Xin, Wenxiu ; Xu, Weiben ; Li, Shujing

ObjectivesThe economic implications of combining rezvilutamide with androgen deprivation therapy (ADT) remain uncertain, despite the observed survival advantages compared with bicalutamide plus ADT. Therefore, this study evaluates the cost-effectiveness of rezvilutamide plus ADT as the first-line treatment of metastatic hormone-sensitive prostate cancer (mHSPC) from the perspective of the Chinese healthcare system.DesignA partitioned survival model was developed to assess the cost-effectiveness of rezvilutamide combined with ADT. Clinical data were obtained from the CHART trial. Costs and utility values were obtained from local estimate and published literature. Only direct medical costs were included in the model.InterventionsRezvilutamide was administered at 240 mg daily or bicalutamide at 50 mg daily until progression.Outcome measuresThe main outputs of the model included costs and quality-adjusted life years (QALYs), which were used to determine the incremental cost-effectiveness ratio (ICER). One-way and probabilistic sensitivity analysis (PSA) were used to explore model uncertainties.ResultsThe rezvilutamide group showed an expected gain of 2.28 QALYs and an incremental cost of US$60 758.82 compared with the bicalutamide group. The ICER for rezvilutamide group versus bicalutamide group was US$26 656.94 per QALY. The variables with the greatest impact on the model results were the utility for progression-free survival state and the price of rezvilutamide. PSA revealed that rezvilutamide group had 100% probability of being cost-effective at a willingness-to-pay threshold of US$35707.5 per QALY.ConclusionRezvilutamide in combination with ADT is more cost-effective compared with bicalutamide plus ADT as the first-line treatment of mHSPC from the perspective of the Chinese healthcare system.

02 Sep 2023·Acta Oncologica

Systemic therapies for high-volume metastatic hormone-sensitive prostate cancer: a network meta-analysis

Review

Author: Mei, Jingchang ; Liu, Shuai ; Liu, Tian ; Liu, Feng ; Zhang, Guiming ; Zhou, Zhonghan

BACKGROUNDWe compared the effectiveness of currently available systemic therapies for high-volume metastatic hormone-sensitive prostate cancer (mHSPC) and aimed to establish the optimal treatment regimen.MATERIAL AND METHODSWe searched multiple databases for randomized controlled trials (RCTs) that evaluated the efficacy of systemic therapy in patients with high-volume mHSPC. Bayesian network meta-analysis was used to indirectly compare overall survival (OS) and progression-free survival (PFS) of various systemic therapies.RESULTSEleven RCTs (6708 participants) finally met the eligibility criteria. Compared with androgen deprivation therapy (ADT) alone, rezvilutamide (REZ) [hazard ratio (HR) = 0.58, 95% confidence interval (CI): 0.44-0.77], abiraterone (ABI) (HR = 0.61, 95% CI: 0.53-0.71), apalutamide (APA) (HR = 0.70, 95% CI: 0.56-0.88), enzalutamide (ENZ) (HR = 0.65, 95% CI: 0.53-0.80), docetaxel (DOC) (HR = 0.72, 95% CI: 0.63-0.84), darolutamide (DAR) + DOC (HR = 0.49, 95% CI: 0.39-0.62), and ABI + DOC (HR = 0.52, 95% CI: 0.38-0.71) significantly improved OS in patients with high-volume mHSPC. Compared with DOC, no advantages were observed for doublet therapies, including REZ, ABI, APA, and ENZ on the basis of ADT, whereas DAR + DOC (HR = 0.68, 95% CI: 0.57-0.82) and ABI + DOC (HR = 0.72, 95% CI: 0.55-0.95) was associated with better OS. The ranking analysis showed that triplet therapy (DAR + DOC + ADT and ABI + DOC + ADT) had the greatest improvement in OS, followed by REZ + ADT. All the regimens showed improved PFS in patients with high-volume mHSPC. Compared with DOC, significant differences were detected for DAR + DOC, ABI + DOC, ENZ + DOC, REZ, and ENZ. According to the ranking analysis, triplet therapy ranked first, followed by ENZ and REZ.CONCLUSIONSREZ + ADT were the highest ranked doublet therapy for improvement in OS of patients with high-volume mHSPC, second only to triplet therapy (DAR + DOC + ADT and ABI + DOC + ADT).

1

News (Medical) associated with Rezvilutamide

10 Aug 2023

·www.pharmaceutical-technology.com

Palisade Bio terminates its post-surgical abdominal adhesions treatment trial

Phalguni Deswal @Phalguni_GD Tranexamic acid is also under development for post-operative ileus, and accelerating the return of bowel function post-abdominal surgery. Image Credit: Buravleva stock / Shutterstock. Palisade Bio has terminated the development of its lead clinical candidate, tranexamic acid (LB1148), for reducing intra-abdominal adhesions in patients after elective bowel resection surgery. The news led to a sharp 69% decline in Palisade’s stock at market open on 9 August, compared to market close on the previous day. The company’s market cap stands at $4.8m. Recommended Reports Reports LOA and PTSR Model - Rezvilutamide in Liver Failure (Hepatic Insufficiency) GlobalData Reports LOA and PTSR Model - Aramchol in Liver Failure (Hepatic Insufficiency) GlobalData View all Companies Intelligence Palisade Bio, Inc Palisade Corp View all Tranexamic acid is a broad-spectrum serum protease inhibitor . It reduces damage to the intestine by neutralising digestive enzymes. The drug was investigated for the indication in a randomised, placebo-controlled, multicentre Phase II clinical trial (NCT02836470) that failed to meet its primary endpoint. Furthermore, 16 serious adverse events were observed in the tranexamic acid group, compared to 14 events in the placebo group, as per the press release . The clinical trial was wrought with difficulties. It was paused in July 2020 due to Covid-19, leading to low patient recruitment. After its restart in May 2022, the study’s protocol was changed to investigate the use of LB1148 in reducing adhesions from its original indication of the return of gastrointestinal function in patients post-elective bowel resection surgery. Tranexamic acid is also under development for post-operative ileus and accelerating the return of bowel function post-abdominal surgery . Palisade has a development and licencing agreement with Newsora for the tranexamic acid programme in China. The agreement grants Palisade clinical, regulatory, and commercial milestone-based payments, as well as tiered royalty payments for net annual sales in greater China. Palisade reduced its workforce by 30% at the start of 2023, as part of a cost-reduction strategy. As per the company’s 2022 financial report , it has cash reserves of $12.4m to fund its operation to mid-2024.

Phase 2Financial Statement

100 Deals associated with Rezvilutamide

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Castration-sensitive prostate cancer	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	28 Jun 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Prostatic Cancer	Phase 3	-	Luzsana Biotechnology, Inc.	18 May 2022
Locally Advanced Prostate Carcinoma	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Nov 2021
Prostate Cancer, Hereditary, 7	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Nov 2021
Castration-Resistant Prostatic Cancer	Phase 3	CZ	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 May 2018
Castration-Resistant Prostatic Cancer	Phase 3	PL	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 May 2018
Castration-Resistant Prostatic Cancer	Phase 3	BG	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 May 2018
Castration-Resistant Prostatic Cancer	Phase 3	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 May 2018
Castration-sensitive prostate cancer	Phase 3	BG	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 May 2018
Castration-sensitive prostate cancer	Phase 3	PL	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 May 2018
Castration-sensitive prostate cancer	Phase 3	CZ	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 May 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03520478 (CHART, Pubmed \| Med)	Phase 3	Hormone-dependent prostate cancer prostate-specific antigen	654	Rezvilutamide plus ADT	(wjyjbmadyd) = wlxhlcbzkq bbsvyupmki (ywtsmpoptv ) View more	Positive	01 Oct 2024
				Bicalutamide plus ADT	(wjyjbmadyd) = vcmjyfrwlo bbsvyupmki (ywtsmpoptv ) View more
NCT05924256 (ASCO2024) Manual	Phase 2	Salivary Gland Neoplasms \| \| \| ... View more	21	SHR-A1811 (HER2 mutation/amplification or HER2 overexpression (IHC 3+ or IHC 2+/ISH+))	(tkyjxeyqkj) = ufulzxiprz lghbsjxcvl (xydqmlsawc ) View more	Positive	24 May 2024
				rezvilutamide + leuprolide (IHC AR+)	(tkyjxeyqkj) = gclljpsipj lghbsjxcvl (xydqmlsawc ) View more
NCT04603833 (ASCO2024)	Phase 2	Metastatic castration-resistant prostate cancer	36	Rezvilutamide 160 mg plus Docetaxel	(ljtgzpkjay) = ncsgxyinqi igovajmkhq (oxukoarttu ) View more	Positive	24 May 2024
				Rezvilutamide 240 mg plus Docetaxel	(ljtgzpkjay) = sjmlonwdmo igovajmkhq (oxukoarttu ) View more
NCT03520478 (CHART, ESMO2023) Manual	Phase 3	Metastatic castration-resistant prostate cancer PSA	654	Rezvilutamide + ADT (deep PSA decline)	-	Positive	22 Oct 2023
				Bicalutamide + ADT (deep PSA decline)
NCT03520478 (CHART, Pubmed) Manual	Phase 3	Castration-Resistant Prostatic Cancer	654	ADT+Rezvilutamide	(pdhucpbbxc) = cqndbsrxvs adqfxofvzy (wkyxlrnbji, NR - NR) View more	Superior	05 Sep 2022
				ADT+Bicalutamide	(pdhucpbbxc) = fmjojrgqnz adqfxofvzy (wkyxlrnbji, 15.7 - NR) View more
NCT03520478 (CHART, ASCO2022)	Phase 3	Castration-Resistant Prostatic Cancer	654	SHR3680	(csbgpcbqob): HR = 0.58 (95% CI, 0.42 - 0.8), P-Value = 0.0009 View more	Positive	02 Jun 2022
				Bicalutamide
NCT02691975 (Pubmed) Manual	Phase 1/2	Metastatic castration-resistant prostate cancer	197	SHR3680	(nootofdszs) = nhvlxxiuul nqsjnxprru (vvzjwngwtk, 61.0 - 74.5) View more	Positive	04 Mar 2022
NCT02691975 (ASCO_GU2020) Manual	Phase 1/2	Metastatic castration-resistant prostate cancer	197	SHR3680	(xxpmlwnfts) = Not reached tsfulktqol (wbjbyvhfqg ) View more	Positive	13 Feb 2020