AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma - LARVOL DELTA

Adebrelimab Combined With Dalpiciclib and Standard Endocrine Therapy for HR + / HER2- Breast Cancer (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Harbin Medical University | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor

Matching-Adjusted Indirect Comparison of Bireociclib Plus Fulvestrant versus Dalpiciclib Plus Fulvestrant as Second-Line Treatment of HR+/HER2- Advanced Breast Cancer (ABC) (ESMO 2025) - No abstract available

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial completion date: Sep 2025 ➔ Sep 2028 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR

Targeted Therapy with Dalpiciclib in a Pediatric Patient with Anaplastic Ependymoma: A Case Study and Literature Review. (PubMed, Recent Pat Anticancer Drug Discov) - "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."

Journal • Brain Cancer • Ependymoma • Oncology • Pediatrics • Solid Tumor

Real-world study on the efficacy and safety of Dalpiciclib in elderly patients with HR-positive, HER2-negative advanced breast cancer in the Xinjiang region (ESMO 2025) - No abstract available

Clinical • Metastases • Real-world • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Neoadjuvant pyrotinib and letrozole plus dalpiciclib for triple-positive breast cancer: three-year outcomes from the MUKDEN 01 study (ESMO 2025) - No abstract available

Clinical • Breast Cancer • Oncology • Solid Tumor

Efficacy and Safety of Dalpiciclib Combined with Endocrine Therapy After Progression on Prior CDK4/6 Inhibitors in HR+/HER2- Advanced Breast Cancer (ESMO 2025) - No abstract available

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Efficacy and Safety of Dalpiciclib, Exemestane, and Goserelin as Neoadjuvant Therapy in Premenopausal HR-positive, HER2-negative Breast Cancer Patients: A Phase 2 Clinical Trial (ChiCTR) - P2 | N=86 | Recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital; Tianjin Medical University Cancer Institute and Hospital

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Fujian Cancer Hospital

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Adjuvant Dalpiciclib Improves Outcomes in HR+/HER2- Early Breast Cancer (Oncology Nurse Advisor) - P3 | N=5274 | DAWNA-A (NCT04842617) | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | "At a median follow-up of 20.3 months, 88.6% of patients in the dalpiciclib arm and 85.2% of those in the placebo arm remained on study treatment. The researchers found that dalpiciclib improved invasive disease-free survival (iDFS). The 24-month iDFS rates were 94.7% in the dalpiciclib arm and 90.2% in the placebo arm. The 36-month iDFS rates were 89.1% and 86.2%, respectively (hazard ratio [HR], 0.56; 95% CI, 0.43-0.71; P <.0001). Dalpiciclib also improved disease-free survival (HR, 0.53; 95% CI, 0.42-0.67; P <.0001) and distant disease-free survival (HR, 0.60; 95% CI, 0.46-0.78; P <.0001)."

P3 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Efficacy and safety of neoadjuvant stereotactic body radiation therapy plus dalpiciclib and exemestane for hormone receptor-positive, HER2-negative breast cancer: A prospective pilot study. (PubMed, Elife) - P=N/A | "None. ClinicalTrials.gov: NCT05132790."

IO biomarker • Journal • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • HER-2 • PD-L1

Dalpiciclib combined with pyrotinib and endocrine therapy in women with ER-positive, HER2-positive advanced breast cancer: A prospective, multicenter, single-arm, phase 2 trial. (PubMed, PLoS Med) - P1/2 | "The non-intravenous, chemotherapy-sparing combination of dalpiciclib, pyrotinib, and endocrine therapy demonstrated anti-tumor activity with a manageable safety profile in the frontline treatment of ER-positive, HER2-positive ABC, supporting its further evaluation as a potential alternative."

Journal • P2 data • Alopecia • Breast Cancer • Estrogen Receptor Positive Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Immunology • Interstitial Lung Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Solid Tumor • BRCA • ER • HER-2

A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors (clinicaltrials.gov) - P1/2 | N=306 | Recruiting | Sponsor: Risen (Suzhou) Pharma Tech Co., Ltd. | Trial completion date: Feb 2026 ➔ Feb 2027 | Trial primary completion date: Feb 2026 ➔ Feb 2027

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

Advancements in Dalpiciclib for the Treatment of Breast Cancer Patients: A Review. (PubMed, Breast Cancer (Dove Med Press)) - "For the present, the CDK4/6 inhibitors that have been widely used for the treatment of breast cancer are palbociclib, abemaciclib and ribociclib. The researches about dalpiciclib with different anti-tumor drugs are ongoing to explore the efficacy and the best strategies to use dalpiciclib. This review provides an overview of the research progress on dalpiciclib across different breast cancer subtypes with various anti-tumor drugs in different treatment opportunities."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Efficacy and Safety of SHR-A1811 Followed by Dalpiciclib and Endocrine Therapy in HR+/HER2-Low/Ultra-Low Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=45 | Not yet recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

New P2 trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A Single-Arm, Exploratory Clinical Study of Pyrotinib Combined with Dalpiciclib and Standard Endocrine Neoadjuvant Therapy in HR-Positive, HER2-Low-Expressing Breast Cancer (ChiCTR) - P=N/A | N=33 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Xiamen University; The First Affiliated Hospital of Xiamen University

New trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Hengrui Pharma Showcases Global Impact at the 2025 ASCO: 72 Study Results Highlight Chinese Cancer Innovation (The Manila Times) - "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."

Clinical data • Breast Cancer • Cholangiocarcinoma • Hepatocellular Cancer • Non Small Cell Lung Cancer • Pancreatic Cancer

Efficacy and safety of dalpiciclib plus toremifene in advanced HR-positive HER2-negative breast cancer as first-line treatment: A multicenter, single-arm phase II trial. (ASCO 2025) - P2 | "The combination of dalpiciclib and toremifene indicated a manageable, expected safety profile. This regimen may offer an viable first-line treatment option for HR+/HER2- mBC, especially for patients intolerant to aromatase inhibitors."

Clinical • Metastases • P2 data • Anorexia • Breast Cancer • CNS Disorders • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Insomnia • Neutropenia • Oncology • Sleep Disorder • Solid Tumor • HER-2

Dalpiciclib plus chidamide in HR+/HER2- advanced breast cancer following CDK4/6 inhibitor treatment failure: Final results of a phase Ib trial. (ASCO 2025) - P1 | "Our results revealed that dalpicilib plus chidamide achieved promising efficacy and safety in HR+/HER2- BC. The combination of dalpiciclib and chidamide may serve as an alternative treatment strategy in HR+/HER2- BC patients following CDK4/6i therapy failure."

Clinical • Metastases • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • ER • HER-2 • MYC • PIK3CA • TP53

Efficacy and safety of dalpiciclib plus fulvestrant and pyrotinib in HR+, HER2-low advanced breast cancer following CDK4/6 inhibitor and aromatase inhibitor: A Bayesian optimal phase Ⅱ trial. (ASCO 2025) - P2 | "Among these patients, 21 (70.0%) received abemaciclib, and 10 (33.3%) received palbociclib and ribociclib. Our results indicated that dalpiciclib plus fulvestrant and pyrotinib achieves promising efficacy and safety in in HR+, HER2-low advanced BC patients following CDK4/6i and AI treatment."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

Dalpiciclib combined with chidamide and letrozole as neoadjuvant therapy for HR-positive, HER2-negative early or locally advanced breast cancer: A single-arm, prospective, exploratory clinical study. (ASCO 2025) - P4 | "Our results showed that the combination of dalpiciclib, chidamide and letrozole demonstrates an acceptable safety profile and promising clinical efficacy, suggesting its potential as an alternative fully oral, chemotherapy-free neoadjuvant treatment for HR-positive, HER2-negative early or locally advanced breast cancer. Further research is needed to validate these findings."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Phase Ib/II study of fluzoparib in combination with dalpiciclib in patients with locally advanced or metastatic sarcoma. (ASCO 2025) - P2 | "This novel combination therapy of CDK4/6 inhibitor and PARP inhibitor showed manageable toxicity that could provide a strategy for advanced or metastatic sarcoma. Part 2 to evaluate safety and efficacy is currently recruiting pts. TRAEs with an incidence of ≥30% and any grade ≥3 TRAEs."

Clinical • Combination therapy • Metastases • P1/2 data • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Sarcoma • Solid Tumor • Thrombocytopenia • HRD

Cetuximab plus dalpiciclib in patients with HPV-negative, anti-PD-1-resistant recurrent or metastatic head and neck squamous cell carcinoma. (ASCO 2025) - P2 | "Dalpiciclib combined with cetuximab was well-tolerated and demonstrated potentially favorable efficacy in patients with anti-PD-1-resistant, HPV-negative R/M HNSCC."

Clinical • Metastases • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Biomarkers of neoadjuvant dalpiciclib in patients with operable HER2-negative luminal B breast cancer in the DANCER trial. (ASCO 2025) - P2 | "Patients with operable HER2-negative luminal B breast cancer who exhibit early ctDNA clearance, MammaPrint low-risk status, GSTM1 deletion, increased pRb/CDK4 expression, and higher plasma CCL4/CCL19 levels may derive substantial benefit from neoadjuvant dalpiciclib therapy."

Biomarker • Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • CCL19 • GSTM1 • HER-2