An Open-Label, Randomized Controlled, Phase III Study of Dalpiciclib Plus Endocrine Therapy Versus Chemotherapy Followed by Endocrine Therapy in High-Risk HR+/HER2- Recurrent or Metastatic Breast Cancer

Start Date15 Dec 2025

Sponsor / Collaborator-

NCT07207070

/ RecruitingPhase 3

A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.

This study is a randomised, open-label, multicentre phase III clinical study evaluating the efficacy and safety of JS105 combined with Dalpiciclib and Fulvestrant compared with Dalpiciclib and Fulvestrant in patients with PIK3CA-mutated, HR-positive, HER2-negative recurrent or metastatic breast cancer.

Start Date12 Nov 2025

Sponsor / Collaborator

Risen (Suzhou) Pharma Technology Co., Ltd.

NCT07238881

/ RecruitingPhase 2IIT

A Prospective, Randomized, Two-Cohort, Exploratory Clinical Study of Dalpiciclib Combined With Camrelizumab in Patients With Unresectable Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors

While immune-based therapies (including targeted-immune or dual-immune regimens) have become first-line standard for advanced hepatocellular carcinoma (HCC), there is a lack of high-level evidence to guide second-line treatment after progression on immune checkpoint inhibitors (ICIs).
Preclinical studies suggest synergistic antitumor activity between CDK4/6 inhibitors and PD-1/PD-L1 blockade. However, no clinical studies have yet evaluated the combination of dalpiciclib and camrelizumab in this setting.
To address this unmet need and explore novel second-line strategies for advanced HCC, we plan to conduct an exploratory clinical trial investigating the efficacy and safety of dalpiciclib plus camrelizumab in patients with unresectable HCC previously treated with ICIs.

Start Date05 Nov 2025

Sponsor / Collaborator

Sun Yat-Sen University

100 Clinical Results associated with Dalpiciclib Isethionate

100 Translational Medicine associated with Dalpiciclib Isethionate

100 Patents (Medical) associated with Dalpiciclib Isethionate

Literatures (Medical) associated with Dalpiciclib Isethionate

01 Oct 2025·MedComm

Efficacy, Safety, and Biomarkers of Neoadjuvant Dalpiciclib (CDK4/6 inhibitor) plus Aromatase Inhibitors in Operable HER2‐Negative Luminal B Breast Cancer: A Prospective, Single‐Center, Single‐Arm, Phase II Trial (DANCER)

Article

Author: Hong, Hui ; Zhou, Yunxiang ; Wu, Shijie ; Ma, Ting ; Ma, Mindi ; Wang, Ze ; Shen, Lu ; Tao, Siqi ; Wang, Hui ; Shen, Yong ; Guo, Xianan ; Chen, Yiding ; Fu, Jun ; Huang, Fengbo ; Mao, Weikang ; Pan, Liqiang ; Chen, Huihui ; Qian, Wei ; Hu, Yue ; Pan, Chi ; Zhang, Jiao ; Zhang, Zhiyun

ABSTRACT:

Dalpiciclib, a cyclin‐dependent kinase 4/6 (CDK4/6) inhibitor, has demonstrated significant clinical activity and manageable safety in advanced luminal breast cancer, yet its neoadjuvant value remains unestablished. The single‐arm, phase II DANCER trial (NCT05640778) is the first to evaluate circulating tumor DNA (ctDNA)‐guided neoadjuvant CDK4/6 inhibitor therapy in patients with operable human epidermal growth factor receptor 2 (HER2)‐negative luminal B breast cancer, a subtype with poor chemotherapy response and unmet neoadjuvant needs. Thirty patients received dalpiciclib plus aromatase inhibitors (DAL‐AI) with ctDNA monitoring and multiomics profiling. At week 2, 26 (86.7%) patients achieved complete cell cycle arrest (primary endpoint). By surgery, 60.0% had partial response; breast pathological complete response and residual cancer burden 0–I rates were 6.7 and 3.3%, respectively. Treatment was well tolerated, with the most common grade ≥3 adverse events being neutropenia and leukopenia. Candidate predictive biomarkers included ctDNA clearance, GSTM1 copy number, MammaPrint index, plasma CCL4/CCL19 levels, and tissue pRb/CDK4 expression. A novel baseline response index combining CCL4 and pRb showed excellent predictive performance and stratified patients by likelihood of clinical benefit, with ctDNA dynamics further refining stratification. These findings support DAL‐AI as a promising neoadjuvant option and highlight the value of biomarker‐guided strategies for treatment optimization.

12 Aug 2025·Recent Patents on Anti-Cancer Drug Discovery

Targeted Therapy with Dalpiciclib in a Pediatric Patient with Anaplastic Ependymoma: A Case Study and Literature Review

Article

Author: Yang, Jia ; Zhang, Hui ; Wu, Huaguo ; Lai, Long ; Tao, Rongjie ; Qi, Yiming ; Li, Yang

Introduction::

Ependymoma is the third most common brain tumor in children, with a high recurrence rate and poor prognosis. The traditional treatment of ependymoma is surgery and radiation therapy. However, the effectiveness of conventional chemotherapy has been modest. Recent breakthroughs in molecular biology and genetics have opened doors to more targeted and effective therapeutic approaches. Complex mutations, such as CDK4 amplification in anaplastic ependymoma, are infrequently documented, warranting further investigation.

Case Presentations::

This case study presents a twelve-year-old girl with a WHO Grade III anaplastic ependymoma. She underwent two surgical procedures, followed by radiotherapy and chemotherapy. Despite this comprehensive treatment, she experienced a relapse after one year. Genetic testing identified CDK4 amplification in the tumor tissue. Subsequently, based on the genetic finding, she was treated with a CDK4/6 inhibitor, Dalpiciclib, in combination with bevacizumab. So far, she has survived for over 48 months following her surgery and continues to be monitored, underscoring the remarkable efficacy of the treatment.

Conclusions::

This report represents the first use of the CDK4/6 inhibitor Dalpiciclib for the treatment of anaplastic ependymoma. The treatment was guided by insights from next-generation sequencing (NGS) analysis and has shown promising results in terms of patient survival.

01 Apr 2025·Cancer Communications

A prospective, phase II, neoadjuvant study based on chemotherapy sensitivity in HR+/HER2‐ breast cancer‐FINEST study

Article

Author: Liu, Guang‐Yu ; Li, Jun‐Jie ; Wu, Wen‐Ya ; Liang, Fei ; Wu, Jiong ; Chen, Li ; Yu, Ke‐Da ; Di, Gen‐Hong ; Wang, Zhong‐Hua ; Fan, Lei ; Shao, Zhi‐Ming

Abstract:

Background:

Hormone receptor‐positive (HR+)/humaal growth factor receptor 2‐negative (HER2‐) breast cancer, the most common breast cancer type, has variable prognosis and high recurrence risk. Neoadjuvant therapy is recommended for median‐high risk HR+/HER2‐ patients. This phase II, single‐arm, prospective study aimed to explore appropriate neoadjuvant treatment strategies for HR+/HER2‐ breast cancer patients.

Methods:

Eligible female patients with newly diagnosed, untreated HR+/HER2‐ breast cancer received 2 cycles of nab‐paclitaxel and carboplatin (nabPCb). Magnetic resonance imaging (MRI) was performed to assess tumor responses, and 40% regression of the maximal tumor diameter was deemed chemo‐sensitive. Chemo‐sensitive patients continued nabPCb for 4 more cycles (group A). Chemo‐insensitive patients were randomized to groups B, C, and D at a ratio of 1:3:1 to receive a new chemotherapy for 4 cycles or endocrine‐immune‐based therapy (dalpiciclib, letrozole and adebrelimab, with goserelin if patients were premenopausal) for 4 cycles or to undergo surgery. Peripheral blood and core‐needle biopsy (CNB) samples were collected before treatment, followed by a next‐generation sequencing (NGS) panel detection and similarity network fusion (SNF) typing through digital pathology data. The primary endpoint was the pathological complete response (pCR) rate, and the secondary endpoint was the clinical objective response rate (ORR).

Results:

A total of 121 patients were enrolled (67.8% with stage III disease), with 76, 9, 27, and 9 patients in groups A, B, C and D, respectively. The total pCR rate was 4.1%, and all patients who received pCR were in group A. Group C had a better ORR than Group B (81.5% vs. 66.7%). Exploratory analysis revealed that patients with the SNF4 subtype were the most sensitive to nabPCb (pCR rate of 21.1% vs. 1.8% in group A), whereas patients in group C with the SNF2 subtype were more sensitive to endocrine‐immune‐based therapy (Miller‐Payne grade 4‐5, 45.5% vs. 6.3%).

Conclusions:

Converting to endocrine‐immune‐based therapy improved the ORR, but not the pCR rate in chemo‐insensitive patients. Neoadjuvant chemotherapy and endocrine therapy are not mutually exclusive. The SNF4 subtype of HR+/HER2‐ breast cancer was more chemo‐sensitive, whereas the SNF2 subtype might be more sensitive to immunotherapy.

News (Medical) associated with Dalpiciclib Isethionate

20 Oct 2025

·www.prnewswire.com

Live from ESMO | Hengrui Debuts Exhibition Booth with Landmark Data Showcasing Pharma's Emerging Innovation Power

BERLIN, Oct. 20, 2025 /PRNewswire/ -- From October 17 to 21, the European Society for Medical Oncology (ESMO) Annual Congress convened in Berlin, bringing together global leaders in oncology and pharmaceutical innovation. Representing China's advancing biopharmaceutical landscape, Hengrui Pharma not only returned with a comprehensive portfolio of oncology research but also debuted as an exhibitor, marking a new milestone in its global academic engagement. Since 2016, Hengrui has presented pioneering research at the ESMO Annual Congress for ten consecutive years. This year, the company unveiled 46 studies across 14 innovative therapeutic programs, including nine oral presentations, two mini oral sessions, and four late-breaking abstracts (LBAs), underscoring its global R&D strength. These data highlight the company's commitment to multi-cancer coverage and multi-mechanism innovation in oncology. In parallel, Hengrui scheduled a series of academic events, fostering in-depth dialogue with leading global experts and clinical researchers on cutting-edge topics in oncology. These initiatives established a dynamic platform for international academic exchange and infused Chinese innovation into the global landscape of cancer diagnosis and treatment – marking a new chapter in Hengrui's journey of international scientific engagement. As one of the world's premier oncology platforms, the ESMO Annual Congress attracts more than ten thousand experts and hundreds of leading international pharmaceutical companies each year. The meeting showcases the latest advances in cancer research and therapeutics, serving as a high-level hub for academic exchange and collaboration. It continues to catalyze innovation and clinical translation across the oncology community, aligning with the 2025 Congress vision: "Standing by those who care about cancer." Global Vision: China Innovation Going Global At the ESMO 2025 Annual Congress, Hengrui co-hosted the roundtable "China Innovation Going Global," bringing together leading Chinese and international experts to discuss strategic pathways and future prospects for the globalization of China-origin innovations. During the global launch of the CARES-009 study, featuring Hengrui's innovative therapeutic combination of camrelizumab and rivoceranib, Academician Jia Fan of the Chinese Academy of Sciences and Professor Jian Zhou of Zhongshan Hospital, Fudan University, jointly presented the latest global data from the study, garnering widespread attention from the international oncology community. Ms. Jo Feng, President and Chief Operating Officer of Hengrui Pharma, led the company's delegation at this year's Congress. She stated, "ESMO serves as a premier global platform for oncology exchange, and this year, Hengrui proudly presented 46 research achievements – highlighting our growing academic presence on the world stage. As an innovation-driven global pharmaceutical company, Hengrui places medical innovation at the heart of its strategic vision, with a steadfast commitment to addressing unmet clinical needs. Looking ahead, we remain firmly patient-centric, continuing to advance groundbreaking therapies to improve the lives of patients worldwide." Breakthroughs Across Multiple Cancer Types At this year's ESMO Annual Congress, Hengrui had 46 oncology research projects accepted, including four LBAs, spanning 14 innovative therapeutic programs. Among these, nine were selected for oral presentations, two for mini oral sessions, 32 as posters, and three as e-posters. Collectively, these studies encompass more than 10 cancer types, including esophagogastric cancer, gynecologic malignancies, liver cancer, breast cancer, pancreatic cancer, lung cancer, sarcoma, biliary tract cancer, head and neck squamous cell carcinoma, prostate cancer, and thyroid cancer. In breast cancer, Hengrui had 11 research studies accepted, comprising one oral presentation, one mini oral, eight posters, and one e-poster. Notably, an LBA featuring Hengrui's antibody-drug conjugate (ADC) trastuzumab rezetecan (SHR-A1811) compared with pyrotinib plus capecitabine for patients with HER2-positive advanced or metastatic breast cancer was selected for presentation. Multiple studies highlighting both established and emerging therapies, including pyrotinib, dalpiciclib, and adebrelimab, demonstrate Hengrui's deep and sustained commitment to advancing breast cancer research. In gastrointestinal cancers, 14 studies were accepted, including two oral presentations, 11 posters, and one e-poster. Alongside flagship therapies such as camrelizumab and rivoceranib, four studies on adebrelimab in the gastrointestinal field were featured. In addition, investigational agents including HRS-4642 (a KRAS G12D inhibitor) and SHR-1701 (a PD-L1/TGF-β bifunctional antibody) were also presented, reflecting the strong momentum of both Hengrui's established portfolio and emerging pipeline in advancing care for patients with gastrointestinal malignancies. In lung cancer, six poster presentations featuring camrelizumab and adebrelimab were accepted, underscoring Hengrui's expanding footprint in this therapeutic area. These studies covered both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), further validating the clinical potential and versatility of these regimens. Across additional disease areas, including gynecologic tumors, thymic epithelial tumors, head and neck squamous cell carcinoma, sarcoma, prostate cancer, and thyroid cancer, Hengrui had 13 studies accepted, featuring a diverse range of innovative therapies such as camrelizumab, fuzuloparib, rivoceranib, rezvilutamide, adebrelimab, famitinib, HRS-7058, and HRS-4642. These included six oral presentations, one mini oral, five posters, and one e-poster, highlighting Hengrui's robust and broad-based R&D capabilities. In addition, two posters were accepted on hetrombopag and ondansetron oral soluble films, focusing on the prevention and management of chemotherapy-induced thrombocytopenia, nausea, and vomiting. Dr. Frank Jiang, Executive Vice President and Chief Strategy Officer of Hengrui Pharma, stated: "At this year's ESMO Annual Congress, we unveiled a broader and more impactful portfolio of research findings. The concentrated release of these breakthrough data not only reflects Hengrui's robust R&D capabilities, but also highlights the results of our science-driven, globally oriented innovation R&D strategy. Our pipeline is both deep and forward-looking – while reinforcing our existing product portfolio, we are also actively expanding into cutting-edge therapeutic areas. We firmly believe that through this in-depth engagement with the global oncology community, we can better enable our breakthroughs to benefit more patients worldwide." A Decade of ESMO Participation: China Innovation Going Global Since 2016, Hengrui Oncology has participated in the ESMO Annual Congress for 10 consecutive years, consistently setting new benchmarks for Chinese pharmaceutical companies. Between 2023 and 2025, Hengrui presented a total of 119 research achievements: 2023: 36 studies accepted, including two preferred oral presentations, six mini oral presentations, and 28 posters, covering multiple therapeutic areas such as gastrointestinal cancers, breast cancer, cervical cancer, pancreatic cancer, and melanoma. 2024: 37 studies accepted, spanning 13 innovative therapies and more than 10 cancer types, including esophagogastric cancer, gynecologic malignancies, liver cancer, breast cancer, and lung cancer. 2025: Marking its first-ever exhibition booth at ESMO, Hengrui presented 46 studies across 14 innovative medicines. This milestone represents a significant step forward in Hengrui's internationalization strategy and its commitment to advancing global cancer care. Commitment to Global Impact with the Promise of Patient Focus Hengrui remains steadfast in its commitment to science and innovation driven by the goal of addressing unmet patient needs. Leveraging a global R&D network, the company is advancing innovative medicines onto the international stage. Through a strategically structured pipeline, continuous breakthroughs across multiple cancer types, and active participation in global academic exchange, Hengrui Oncology is accelerating the internationalization and bringing new hope and broader treatment options to patients worldwide. About Hengrui Pharma Hengrui Pharma is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. Its therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. Founded in 1970 with the core principle of putting patients first, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology. About Hengrui Oncology Hengrui Oncology specializes in the development, production, and global commercialization of innovative cancer therapies. It is the first business unit within Hengrui to achieve technological breakthroughs and successfully enter international markets. Hengrui Oncology has established a robust and diversified oncology pipeline encompassing multiple tumor types, with a comprehensive portfolio that includes immunotherapies, targeted therapies, and ADCs. In key areas such as breast cancer, Hengrui Oncology provides full-course treatment solutions that span multiple lines of therapy. To date, 14 novel oncology agents developed by Hengrui have been approved for marketing in China. SOURCE Hengrui Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASCOImmunotherapyDrug Approval

05 Jun 2025

·www.prnewswire.com

Hengrui Pharma Showcases Global Impact at the 2025 ASCO: 72 Study Results Highlight Chinese Cancer Innovation

SHANGHAI, June 5, 2025 /PRNewswire/ -- The 2025 ASCO Annual Meeting successfully concluded in Chicago on June 3 (local time). Hengrui Pharma delivered a strong international presence, featuring 15 innovative drugs and 72 research outcomes. These included 4 oral presentations, 5 rapid oral presentations, 27 poster presentations, and 36 online publications. Multiple groundbreaking research advances has elicited widespread discussion among global experts. In the field of breast cancer, results from 19 studies evaluating the company's innovative drugs—pyrotinib, dalpiciclib, camrelizumab, apatinib, adebrelimab, Trastuzumab rezetecan (SHR-A1811), and SHR-2017, either in combination with each other or with chemotherapies, were presented at ASCO 2025. Notably, 7 studies involving pyrotinib and 6 studies involving dalpiciclib were selected, with both agents consistently demonstrating promising efficacy, reinforcing their established roles in breast cancer treatment. Furthermore, studies evaluating SHR-A1811 and adebrelimab were selected for rapid oral presentations, attracting considerable attention from the industry. In the field of gastrointestinal cancers, drugs such as camrelizumab, apatinib, adebrelimab, and SHR-8068 were featured in a total of 30 accepted studies. Notably, camrelizumab was included in 21 of these studies, demonstrating its broad therapeutic profile and potential while reinforcing its position as a key focus at ASCO. This further solidifies the achievements of China-developed PD-1 inhibitors on the global stage. Additionally, adebrelimab, which has achieved significant breakthroughs in lung cancer in recent years, is actively expanding into new indications. At this year's ASCO, five related studies exploring adebrelimab's efficacy in indications such as hepatocellular carcinoma (HCC), cholangiocarcinoma (CCA) , and pancreatic cancer were presented. The ongoing emergence of cutting-edge research on both established and emerging agents holds promise for improving clinical outcomes for patients with gastrointestinal tumors. Across a wide range of disease areas—including lung cancer, gynecologic cancers, lymphoma, bladder cancer, head and neck cancer, melanoma, sarcoma, nasopharyngeal carcinoma, chordoma, salivary gland cancer, thymic cancer, desmoid tumors, and salivary duct carcinoma—Hengrui Pharma's innovative oncology portfolio (camrelizumab, apatinib, adebrelimab, pyrotinib, dalpiciclib, fluzoparib, famitinib, SHR-A1811, SHR-1501, SHR-1701, SHR-1826, SHR-A1912, and SHR-A2102) was featured in 22 research presentations at ASCO 2025. These comprised 4 oral presentations, 2 rapid oral presentations, 12 poster presentations, and 4 online publications, collectively demonstrating the company's robust R&D capabilities. Additionally, one online publication highlighted ondansetron oral soluble film, underscoring its favorable efficacy in preventing and treating chemotherapy-induced nausea and vomiting (CINV). For 15 consecutive years, Hengrui Pharma has consistently presented its cutting-edge research at the ASCO Annual Meeting, highlighting the company's global leadership in oncology drug research and development while showcasing China's robust pharmaceutical innovation capabilities to the international academic community. The inclusion of 70 Hengrui-sponsored studies at this year's meeting reflects the strong foundation laid by the company's portfolio of 23 marketed innovative drugs and a robust pipeline of over 90 candidates currently in development. Looking ahead, Hengrui will remain committed to its patient-centric approach, striving to develop advanced therapeutics that support the "Healthy China" initiative and enhance clinical outcomes for patients globally. SOURCE Hengrui Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASCOClinical ResultCSCO

15 Oct 2024

·www.prnewswire.com

Metastatic Castration-Sensitive Prostate Cancer Clinical Trial Pipeline Insights Featuring 35+ Companies | DelveInsight

Metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC), refers to prostate cancer that has spread beyond the prostate but still responds to therapies that lower testosterone (castration) with an aging population, the incidence of prostate cancer is rising, leading to an increased demand for advanced therapies to treat metastatic forms of the disease. LAS VEGAS, Oct. 15, 2024 /PRNewswire/ -- DelveInsight's ' Metastatic Castration-Sensitive Prostate Cancer Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline mCSPC therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the mCSPC pipeline domain. Key Takeaways from the Metastatic Castration-Sensitive Prostate Cancer Pipeline Report DelveInsight's mCSPC pipeline report depicts a robust space with 35+ active players working to develop 40+ pipeline therapies for mCSPC treatment. Key mCSPC companies such as Tavanta Therapeutics, AstraZeneca, Regeneron Pharmaceuticals, Astellas Pharma, Propella Therapeutics, POINT Biopharma, Amgen, Janssen Research & Development, LLC, Bayer, Beigene, Amgen, Merck Sharp & Dohme LLC, Jiangsu HengRui Medicine Co., Ltd., Suzhou Kintor Pharmaceutical Inc, Astellas Pharma, and others are evaluating new mCSPC drugs to improve the treatment landscape. Promising mCSPC pipeline therapies such as TAVT-45 (abiraterone acetate), Saruparib (AZD5305), Capivasertib, REGN2810, Abiraterone decanote + dexamethasone or prednisone (PRL-02/ASP5541), [Ac-225]-PSMA-62, Xaluritamig, Apalutamide, Darolutamide, Luteinizing Hormone Releasing Hormone, Pembrolizumab, Dalpiciclib isethionate, GT0918, PRL-02, and others are under different phases of mCSPC clinical trials. In October 2024, Apalutamide (Erleada) was found to provide a significant improvement in overall survival (OS) at 24 months compared with enzalutamide (Xtandi) in the treatment of androgen receptor pathway inhibitor (ARPI)-naïve patients with metastatic castration-sensitive prostate cancer (mCSPC). In April 2024, Saruparib (AZD5305) demonstrated encouraging efficacy, favorable safety, a wide therapeutic index, and improved pharmacokinetic properties compared with currently approved PARP inhibitors in patients with advanced solid tumors harboring BRCA1/2, PALB2, or RAD51C/D mutations, according to findings from the Phase I/IIa PETRA study. In February 2024, Capivasertib combined with docetaxel to enhance anti-tumour activity through inhibition of AKT-mediated survival mechanisms in prostate cancer. Capivasertib can enhance anti-tumour effects of docetaxel by targeting residual docetaxel-persister cells, independent of PTEN status, to induce apoptosis and DNA damage in part through GSK3β. In January 2023, Tavanta Therapeutics announced positive top-line results from its pivotal, global Phase III clinical trial, evaluating the safety and efficacy of TAVT-45 (abiraterone acetate). The trial met its primary objective of establishing therapeutic equivalence of TAVT-45 to Zytiga® in patients with metastatic castrate-resistant prostate cancer (mCRPC) and metastatic high-risk castrate-sensitive prostate cancer (mCSPC), in addition to demonstrating a comparable safety profile. Request a sample and discover the recent advances in mCSPC treatment drugs @ Metastatic Castration-Sensitive Prostate Cancer Pipeline Report The mCSPC pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage mCSPC drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the mCSPC clinical trial landscape. Metastatic Castration-Sensitive Prostate Cancer Overview Metastatic castration-sensitive prostate cancer (mCSPC) is an advanced form of prostate cancer in which the cancer cells have spread beyond the prostate to other parts of the body, such as bones or lymph nodes, but remain responsive to hormone therapy. This means that reducing testosterone levels can still effectively slow the growth of cancer cells. mCSPC often arises when prostate cancer is initially diagnosed or when early-stage prostate cancer recurs after treatment. It is distinct from castration-resistant prostate cancer (CRPC), where the cancer continues to progress despite low testosterone levels. The causes of mCSPC primarily involve the spread of prostate cancer cells beyond the local prostate region, a process called metastasis. Although the exact mechanisms are complex, certain risk factors increase the likelihood of developing prostate cancer and its progression to metastatic disease. These risk factors include advanced age, a family history of prostate cancer, genetic mutations such as BRCA1/BRCA2, and race. Symptoms of mCSPC can include bone pain, urinary issues, fatigue, weight loss, and general malaise, especially if the cancer has spread to bones or lymph nodes. However, in many cases, early stages of metastasis may be asymptomatic, making regular screening essential for those at risk. Diagnosis of mCSPC typically involves a combination of blood tests, such as measuring prostate-specific antigen (PSA) levels, imaging studies, and biopsy to confirm the presence of cancer cells. Treatment for mCSPC revolves around androgen deprivation therapy to lower testosterone levels, often combined with other agents like chemotherapy (e.g., docetaxel) or second-generation androgen receptor inhibitors (e.g., abiraterone or enzalutamide). In recent years, clinical trials have shown the benefit of combining ADT with novel therapies to improve survival rates and manage symptoms, with personalized treatment approaches based on genetic testing becoming more common. Find out more about mCSPC treatment drugs @ Drugs for Metastatic Castration-Sensitive Prostate Cancer Treatment A snapshot of the mCSPC Pipeline Drugs mentioned in the report: Learn more about the emerging mCSPC pipeline therapies @ Metastatic Castration-Sensitive Prostate Cancer Clinical Trials Metastatic Castration-Sensitive Prostate Cancer Therapeutics Assessment The mCSPC pipeline report proffers an integral view of the mCSPC emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Metastatic Castration-Sensitive Prostate Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous Therapeutics Assessment By Molecule Type: Small molecule, Cell therapy, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: Steroidal inhibitor of CYP17A1, PARP1 inhibitor, Proto-oncogene protein c-akt inhibitors, CYP17 lyase inhibitor, Antibody-dependent cell cytotoxicity, Immunostimulants, T lymphocyte stimulants, Ionizing radiation emitters. Key Metastatic Castration-Sensitive Prostate Cancer Companies: Tavanta Therapeutics, AstraZeneca, Regeneron Pharmaceuticals, Astellas Pharma, Propella Therapeutics, POINT Biopharma, Amgen, Janssen Research & Development, LLC, Bayer, Beigene, Amgen, Merck Sharp & Dohme LLC, Jiangsu HengRui Medicine Co., Ltd., Suzhou Kintor Pharmaceutical Inc, Astellas Pharma, and others. Key Metastatic Castration-Sensitive Prostate Cancer Pipeline Therapies: TAVT-45 (abiraterone acetate), Saruparib (AZD5305), Capivasertib, REGN2810, Abiraterone decanote + dexamethasone or prednisone (PRL-02/ASP5541), [Ac-225]-PSMA-62, Xaluritamig, Apalutamide, Darolutamide, Luteinizing Hormone Releasing Hormone, Pembrolizumab, Dalpiciclib isethionate, GT0918, PRL-02, and others. Dive deep into rich insights for new drugs for mCSPC treatment, visit @ Metastatic Castration-Sensitive Prostate Cancer Drugs Table of Contents For further information on the mCSPC Cancer pipeline therapeutics, reach out @ Metastatic Castration-Sensitive Prostate Cancer Treatment Drugs Related Reports Metastatic Castration-Sensitive Prostate Cancer Market Metastatic Castration-Sensitive Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key mCSPC companies including Myovant Sciences, Pfizer, Bayer, Orion, Novartis, AstraZeneca, Pfizer, Janssen, Merck, Eli Lilly, among others. Metastatic Prostate Cancer Market Metastatic Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key metastatic prostate cancer companies including AstraZeneca, Arvinas, Madison Vaccines, Phosplatin Therapeutics, Hinova Pharmaceuticals, Bristol Myers Squibb, Merck, MacroGenics, Daiichi Sankyo, Seagen, Taiho Pharmaceutical, Modra Pharmaceuticals, Xencor, Point Biopharma, Lantheus Holdings, Zenith Epigenetics, Essa Pharma, Telix Pharmaceuticals, Kintor Pharmaceutical, AB Science, Eli Lilly and Company, Exelixis among others. Metastatic Castration-Resistant Prostate Cancer Market Metastatic Castration-Resistant Prostate Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key mCRPC companies including AstraZeneca, Merck Sharp & Dohme, Hinova Pharmaceuticals, Pfizer, Astellas Pharma, Modra Pharmaceuticals, AB Science, Eli Lilly and Company, Zr Pharma & GmbH, Bristol-Myers Squibb, Ipsen, Exelixis, Takeda, Janssen Research & Development, Tesaro, Lantheus Holdings, Kintor Pharmaceutical, MacroGenics, Daiichi Sankyo, Madison Vaccines, Novartis, Point Biopharma, Xencor, Essa Pharma, Telix International, Bayer, Arvinas, among others. Metastatic Castration-Resistant Prostate Cancer Pipeline Metastatic Castration-Resistant Prostate Cancer Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key mCRPC companies, including AstraZeneca, Merck Sharp & Dohme, Hinova Pharmaceuticals, Pfizer, Astellas Pharma, Modra Pharmaceuticals, AB Science, Eli Lilly and Company, Zr Pharma & GmbH, Bristol-Myers Squibb, Ipsen, Exelixis, Takeda, Janssen Research & Development, Tesaro, Lantheus Holdings, Kintor Pharmaceutical, MacroGenics, Daiichi Sankyo, Madison Vaccines, Novartis, Point Biopharma, Xencor, Essa Pharma , Telix International, Bayer, Arvinas, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical Result

100 Deals associated with Dalpiciclib Isethionate

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hormone receptor positive HER2 negative breast cancer	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	31 Dec 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Castration-sensitive prostate cancer	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	19 Oct 2023
HER2-negative breast cancer	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 Apr 2021
Hormone receptor positive breast cancer	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 Apr 2021
Node-positive breast cancer	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	30 Apr 2021
Advanced breast cancer	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	13 Jun 2019
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	13 Jun 2019
Metastatic castration-resistant prostate cancer	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	31 Jul 2024
ER-positive/HER2-negative Breast Cancer	Phase 2	China	Shandong Suncadia Medicine Co., Ltd.	20 Dec 2023
Ewing Sarcoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jul 2023
Metastatic Soft Tissue Sarcoma	Phase 2	China	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Jul 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT07014410 (SYSUCC-002, SABCS2025)	Phase 2	Metastatic human epidermal growth factor 2 positive carcinoma of breast First line HER2-Positive \| Estrogen Receptor-Positive	16	PyrotinibDalpiciclibLetrozoleib + PyrotinibDalpiciclibLetrozole + PyrotinibDalpiciclibLetrozole (Estrogen Receptor-Positive and HER2-Positive Metastatic Breast Cancer)	krpnmawrhu(gembqsphge) = xfdxvotepc zugqbqijbe (swjyulgwhl, 41 - 88)	Positive	12 Dec 2025
SABCS2025	Phase 2	Hormone receptor positive HER2 negative breast cancer Neoadjuvant HR-positive \| HER2-negative	45	Dalpiciclib 150 mg/d + Aromatase Inhibitors (letrozole 2.5 mg/d, anastrozole 1 mg/d, or exemestane 25 mg/d)	pjxbqujicd(gevxauyxke) = xrzmemcfko pexlxkbfqr (oilxrnhjtf, 29.6 - 64.2) View more	Positive	11 Dec 2025
NCT06107673 (DARLING-02, SABCS2025)	Phase 2	HER2-negative breast cancer Neoadjuvant HR+ \| HER2-	158	Dalpiciclib +Letrozole	mxllnsuavn(tqzvlvbvcz) = drikhrecly mhjjiyksbj (duzhzkerwc ) View more	Positive	10 Dec 2025
NCT06107673 (DARLING-02, SABCS2025)	Phase 2	HER2-negative breast cancer Neoadjuvant HR+ \| HER2-	158	Chemotherapy (Epirubicin + Cyclophosphamide + Docetaxel)	mxllnsuavn(tqzvlvbvcz) = qieywicpjk mhjjiyksbj (duzhzkerwc ) View more	Positive	10 Dec 2025
ESMO2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer HR+ \| HER2-	58	Dalpiciclib plus ET	xtjfhflsuj(qkztagdbpk) = dmazvojtvn rshbnxcxap (xhvrthxzrl, 5.2 - 11.0) View more	Positive	17 Oct 2025
ESMO2025	Not Applicable		58	Dalpiciclib plus ET (without liver metastases)	xtjfhflsuj(qkztagdbpk) = zqqsiwczuo rshbnxcxap (xhvrthxzrl )	Positive	17 Oct 2025
NCT04486911 (MUKDEN 01, ESMO2025)	Phase 2	ER positive, PR positive, HER2 positive breast cancer First line \| Neoadjuvant ER Positive \| PR Positive \| HER2 Positive	81	Pyrotinib+Letrozole+Dalpiciclib	tayxwdjcvw(mmwuyaozyi) = cqlcrtdoxn bahprgvzup (naejijjqtn, 88.6 - 99.1) View more	Positive	17 Oct 2025
NCT03772353 (PLEASURABLE, Pubmed \| PLoS Med)	Phase 2	ER-positive/HER2-positive Breast Cancer First line ER-positive \| HER2-positive	48	Dalpiciclib + Pyrotinib + Endocrine therapy	pnrlfsaaiz(crepdikkzf) = mgbvobaaoe ylsxzakles (tnkzzxphnw, 55.1 - 82.7) View more	Positive	31 Jul 2025
ChiCTR2400081280 (ASCO2025) Manual	Phase 4	Hormone receptor positive HER2 negative breast cancer Neoadjuvant HR Positive \| HER2 Negative	23	Dalpiciclib + Chidamide + Letrozole	fdjxiktnlr(qawwgfjghp) = naytevwjlv tafxomejca (byueprokpk, 5.5 - 49.5) View more	Positive	30 May 2025
NCT05586841 (ASCO2025) Manual	Phase 1	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| HR Positive	22	dalpiciclib + chidamide	surrqbxjkp(aqyiptlqbt) = the MTD was established as Group C (dalpiciclib 100 mg/d, chidamide 25 mg BIW). hbejsyrfix (olxphygwqm )	Positive	30 May 2025
NCT05586841 (ASCO2025) Manual	Phase 1		22	dalpicicldalpiciclibchidamide (Group C: dalpiciclib 100 mg/d, chidamide 25 mg BIW)		Positive	30 May 2025
NCT06495515 (ASCO2025)	Phase 2	HR Positive/HER2 Negative/Node positive breast cancer First line HR+ \| HER2-negative	26	Dalpiciclib plus Toremifene	rzlyegbnjq(ghpafuohyi) = nxndvnpncf axxicqjyul (ouhyhkhdqp ) View more	Positive	30 May 2025
NCT04842617 (DAWNA-A, ASCO2025)	Phase 3	Early Stage Breast Carcinoma Adjuvant HR+ \| HER2-	5,274	Dalpiciclib (Dalp) + Endocrine Therapy (ET)	yzxbkhyhqb(qzwwscodke): HR = 0.56 (95% CI, 0.43 - 0.71)	Positive	30 May 2025
NCT04842617 (DAWNA-A, ASCO2025)	Phase 3	Early Stage Breast Carcinoma Adjuvant HR+ \| HER2-	5,274	Placebo + Endocrine Therapy (ET)	yzxbkhyhqb(qzwwscodke): HR = 0.56 (95% CI, 0.43 - 0.71)	Positive	30 May 2025

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis