AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma - LARVOL DELTA

Safety and quality of life of CDK4/6 inhibitors therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: a multicenter cross-sectional survey in China. (PubMed, BMC Cancer) - "The safety profile of different CDK4/6i varies and has different impacts on patients' quality of life, which needs more attention in clinical practice."

HEOR • Journal • Alopecia • Breast Cancer • Fatigue • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Immunology • Leukopenia • Neutropenia • Oncology • Solid Tumor • HER-2

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

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

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

Dalpiciclib (Dalp) plus endocrine therapy (ET) as adjuvant treatment for HR+/HER2– early breast cancer (BC): The randomized, phase 3, DAWNA-A trial. (ASCO 2025) - P3 | "Patients (pts) were randomized (1:1) to receive oral Dalp (125 mg QD; 3-wk on/1-wk off, for 2 y) + ET (letrozole 2.5 mg/anastrozole 1 mg/tamoxifen 10 mg/toremifene 60 mg QD, for 5 y) or placebo + ET. Addition of Dalp to ET as adjuvant treatment significantly improved iDFS, with a tolerable safety profile. These data support the use of Dalp for treating HR+/HER2- early BC. Efficacy outcomes.*Kaplan–Meier method."

Clinical • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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

Dalpiciclib plus aromatase inhibitor versus neoadjuvant chemotherapy for ER-positive, HER2-negative breast cancer. (PubMed, Front Oncol) - "This study indicates that the combination of dalpiciclib and AI elicits comparable responses and demonstrates improved safety profiles when compared to NCT in patients with HR+ HER2 negative breast tumors. Furthermore, RCB and pCR may not serve as optimal endpoints for evaluating the efficacy of CDK4/6i-based NET."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CDK4 • ER • HER-2

DNADalHR: ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer (clinicaltrials.gov) - P2 | N=393 | Not yet recruiting | Sponsor: Peking University People's Hospital

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

Mecapegfilgrastim for the Prevention of Dalpiciclib -Induced Neutropenia in Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=132 | Active, not recruiting | Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2023 ➔ Jan 2025

Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

Efficacy and safety of first-line CDK4/6 inhibitors plus AI therapy for patients with HR +/HER2- advanced breast cancer: a network meta-analysis. (PubMed, BMC Cancer) - "There was no statistically significant difference in PFS among the four CDK4/6 inhibitors. Dalpiciclib has the best therapeutic effect in PFS. Meanwhile, dalpiciclib has the highest risk of adverse events and the 3/4 adverse events incidence compared with the others."

Clinical • Journal • Retrospective data • Review • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Hengrui Medicine (600276.SH): The application for marketing authorization of CDK4/6 inhibitor dalpiciclib Isethionate Tablets has been accepted [Google translation] (Zhitong Finance) - "According to the Zhitong Finance APP, Hengrui Medicine...issued an announcement that recently, the company received the 'Acceptance Notice' issued by the National Medical Products Administration ('NMPA'), and the company's independently developed CDK4/6 inhibitor dalpiciclib Isethionate Tablets' drug marketing authorization application was accepted by the NMPA. It is said that the main purpose of SHR6390-Ⅲ-303 is to evaluate the effectiveness of dalpiciclib combined with endocrine therapy in the adjuvant treatment of HR-positive and HER2-negative breast cancer."

China filing • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Discovery of INV-6452, a CDK2/4 inhibitor for the treatment of HR-positive HER2-negative breast cancer resistant to current CDK4/6 therapy (AACR 2025) - "CDK4/6 Inhibitors represented by palbociclib, ribociclib, abemaciclib and dalpiciclib, working through their inhibitory activities toward G1/S transition cyclin-dependent protein kinases 4 and 6 coupled with cyclins D1 and D3, have emerged as one of the mainstream therapies for HR positive HER2 negative breast cancer. Additionally, INV-6452 had a limited impact on the proliferation and myeloid-specific differentiation of human hematopoietic stem and progenitor cells. The promising profiles of INV-6452 suggest its potential in addressing unmet medical needs, and its clinical development is being planned."

Late-breaking abstract • Breast Cancer • Endometrial Cancer • Eye Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Solid Tumor • CDK1 • CDK4 • CDK9 • HER-2

Clinical and Translational Study for the Strategy Optimization of Neoadjuvant Endocrine Therapy in HR+/HER2- Breast Cancer (GBCC 2025) - P4 | "Patients were grouped according to Ki-67 (cut-off 10%): (A) AIs-response (Ki- 67 ≤ 10% after NET), patients underwent surgery; (B) AIs-nonresponse (Ki-67 > 10%), patients received AIs+CDK4/6i (Dalpiciclib) for 1 cycle, then performed surgery... Neoadjuvant endocrine therapy identified patients sensitive to AIs based on their Ki-67 response. For patients initially unresponsive, CDK4/6i combination therapy significantly reduced Ki-67 levels, highlighting these individuals as potential candidates for intensive adjuvant therapy with CDK4/6i. Additionally, malignant epithelial cells and SERPINA6 emerged as potential therapeutic targets for addressing CDK4/6i- resistance."

Clinical • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • BATF • CD8 • CDK4 • HER-2 • PMAIP1 • SERPINA6

Dalpicilib Plus Cetuximab Compared With Cetuximab Alone in HPV-negative, Anti-PD-1-resistant R/M HNSCC (clinicaltrials.gov) - P2 | N=98 | Recruiting | Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Dalpiciclib Plus Aromatase Inhibitor Versus Neoadjuvant Chemotherapy for ER-Positive, HER2-negative Breast Cancer (Front Oncol) - "Between May 2022 and June 2023, a total of 36 patients were treated with dalpiciclib plus AI, while 137 patients received NCT for the final analysis. Prior to propensity score matching (PSM), the rates of RCB 0 were 0% in the NET group and 7.3% in the NCT group (p=0.205). The rates of bpCR were 2.8% for the NET group and 13.1% for the NCT group (p=0.142). The ORR was comparable between the two groups (p=0.397), as were the rates of BCS (p=0.608). Both treatment groups demonstrated significant reductions in Ki-67 levels, although the extent of reduction was similar (p=0.174). Notably, a Ki-67 level of ≤ 10% post-treatment was more prevalent in the NET group (p<0.0001)."

Retrospective data • Estrogen Receptor Positive Breast Cancer • HER2 Negative Breast Cancer

To evaluate the efficacy of trastuzumab + pyrotinib + dalpiciclib ± letrozole in HER2-positive early breast cancer without chemotherapy (single center, single arm study) (ChiCTR) - P4 | N=161 | Not yet recruiting | Sponsor: Xiangya Hospital, Central South University; Xiangya Hospital, Central South University

New P4 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy and safety of dalsiris in combination with an adjuvant aromatase inhibitor in patients with HR+/HER2- locally advanced breast cancer: a multicenter, cohort study (ChiCTR) - P=N/A | N=300 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Union Hospital, Tongji Medical College, Huazhong University o

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

CDK4/6 as a Therapeutic Target in HR+/HER2- Breast Cancer Cells-Current Treatment Status. (PubMed, Cancers (Basel)) - "Moreover, dalpiciclib is being investigated in HR+/HER2- BC treatment. This article will summarize clinical efficacy, recommendations, and differences in toxicity profile between palbociclib, ribociclib, and abemaciclib and will also discuss the possibility of using dalpiciclib in the treatment of breast cancer."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • CDK4 • HER-2

A meta-analysis and systematic review of different cyclin-dependent kinase 4/6 inhibitors in breast cancer. (PubMed, Front Oncol) - "Meanwhile, we recommend close monitoring and management of these potential side effects when utilizing these inhibitors in breast cancer treatment. https://www.crd.york.ac.uk/PROSPERO, identifier CRD42023490499."

Journal • Retrospective data • Review • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

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

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer (clinicaltrials.gov) - P1 | N=102 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Trial primary completion date: Dec 2024 ➔ Jun 2025

Monotherapy • Trial primary completion date • Breast Cancer • Oncology • Solid Tumor

Hepatic Adverse Events with CDK4/6 Inhibitors: A systematic review combining meta-analysis and FAERS Database. (PubMed, Expert Opin Drug Saf) - "Palbociclib, ribociclib, and abemaciclib caused liver damage, while dalpiciclib did not. The most common manifestations were elevated ALT and AST levels."

Adverse events • Journal • Retrospective data • Review • Breast Cancer • Hepatology • Oncology • Solid Tumor