AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma - LARVOL DELTA

Next Frontier in HER2+/HR+ Breast Cancer: Leveraging Cell Cycle Control with CDK4/6 Inhibitors. (PubMed, J Pers Med) - "Preclinical studies have demonstrated synergistic antitumor activity when CDK4/6 inhibitors are combined with trastuzumab, pertuzumab, or newer HER2-targeted agents across multiple HER2+ breast cancer models. In the metastatic setting, phase II trials including MonarcHER and PATRICIA II have shown encouraging efficacy signals, while the phase III PATINA trial demonstrated a clinically meaningful 15.2-month progression-free survival benefit with palbociclib plus anti-HER2 therapy and endocrine therapy...Despite these advances, key challenges remain including the identification of predictive biomarkers, optimal treatment sequencing, and the integration of emerging HER2-targeted agents such as trastuzumab deruxtecan. Novel CDK4/6 inhibitors including dalpiciclib and next-generation agents are expanding therapeutic options, while combination strategies incorporating CDK7 inhibition represent future therapeutic frontiers. The evolving landscape of HER2+/HR+ breast cancer..."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • CCND1 • ER • HER-2

Efficacy and Safety of Dalpiciclib in HR-Positive Advanced Breast Cancer: A Two-Center Retrospective Study. (PubMed, Cancers (Basel)) - " Dalpiciclib combined with endocrine therapy is associated with favorable efficacy and safety in real-world settings, with early-line treatment and lower tumor proliferative activity associated with better outcomes. While findings suggest potential for clinical application, further large-scale prospective studies are needed to validate its effectiveness in different patient subgroups and optimize treatment strategies."

Journal • Retrospective data • Breast Cancer • Febrile Neutropenia • Hematological Disorders • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Leukopenia • Neutropenia • Oncology • Solid Tumor

CDK4/6 inhibitor dalpiciclib combined with mFOLFOX6 in pretreated metastatic colorectal cancer: Results from a Simon two-stage phase II study (AACR 2026) - "Abstract is embargoed at this time."

Metastases • P2 data • Colorectal Cancer • Oncology • Solid Tumor

A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy. (clinicaltrials.gov) - P3 | N=912 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2026 ➔ Mar 2026

Enrollment open • Trial initiation date • Breast Cancer • Oncology • Solid Tumor

Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Hebei Medical University Fourth Hospital

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

OBU-BC-II-164: Multigene Risk Score Combined With Ki-67 Dynamic Assessment in Stratified Neoadjuvant Endocrine Therapy Treatment With or Without CDK4/6 Inhibitors in HR+/HER2- Breast Cancer (clinicaltrials.gov) - P2 | N=100 | Enrolling by invitation | Sponsor: Peking University | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment (clinicaltrials.gov) - P3 | N=258 | Recruiting | Sponsor: Fujian Cancer Hospital

New P3 trial • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Dalpicilib combined with cetuximab in patients with HPV-negative, anti-PD-1-resistant recurrent or metastatic head and neck squamous cell carcinoma: A phase II trial. (PubMed, Nat Commun) - P2 | "No grade 4 or 5 TRAEs were observed. Dalpiciclib combined with cetuximab was well-tolerated and showed promising efficacy in patients with anti-PD-1-resistant, HPV-negative recurrent and/or metastatic HNSCC."

Journal • P2 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Dalpiciclib Combined with Endocrine Therapy and Concomitant Radiotherapy in Early-Stage HR+/HER2– Breast Cancer:A Phase II Study (EBCC 2026) - No abstract available

P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

CDK4/6 Inhibitors Intensification for Chemotherapy Omission in Small Size High-risk ER-positive Breast Cancer（Cinnamon） (clinicaltrials.gov) - P3 | N=2288 | Not yet recruiting | Sponsor: Fudan University

New P3 trial • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

Adebrelimab in combination with dalpiciclib and endocrine therapy as neoadjuvant treatment for HR+/HER2- early breast cancer: an exploratory study. (PubMed, Int J Surg) - "This triplet regimen demonstrated modest clinical activity in HR+/HER2- early BC, with the safety profile of this regimen remains a concern and warrants particular attention in clinical practice."

Journal • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Infectious Disease • Leukopenia • Neutropenia • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • HER-2

Real-world effectiveness of dalpiciclib-based regimens in patients with hormone receptor-positive advanced breast cancer (ESMO-BC 2026) - No abstract available

Clinical • Metastases • Real-world • Real-world effectiveness • Real-world evidence • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Dalpiciclib plus letrozole or anastrozole as first-line treatment for HR+/HER2- advanced breast cancer (DAWNA-2): A phase III trial (ESMO 2022) - P3 | "Clinical trial identification NCT03966898. Conclusions Adding dalp to letrozole/anastrozole significantly prolonged PFS in HR+/HER2- ABC, with manageable toxicities. Dalp is the 4 th CDK4/6 inhibitor showing survival benefit with letrozole or anastrozole in untreated HR+/HER2- ABC, or with fulvestrant in pretreated HR+/HER2- ABC, in addition to palbociclib, ribociclib and abemaciclib."

Clinical • Late-breaking abstract • P3 data • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Cyclin-Dependent 4/6 Kinase Inhibitors for Treatment of HER2-Positive Breast Cancer: 2026 Update. (PubMed, Cancers (Basel)) - "Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i; palbociclib, ribociclib, abemaciclib, dalpiciclib) combined with endocrine therapy (ET) were a major advance in the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) worldwide...However, clinical development of CDK4/6i in HER2+ MBC slowed, given the advent of highly effective tyrosine-kinase inhibitors (TKIs) (i.e., tucatinib) and antibody-drug conjugates (ADCs) (i.e., trastuzumab deruxtecan), which currently dominate the treatment armamentarium...Subsequently, the phase III PATINA trial (which included patients with 1L HR+HER2+ MBC, treated with palbociclib vs. placebo with maintenance ET+ H[P]) noted a striking PFS improvement of >15 months in the palbociclib arm, renewing interest in CDK4/6i-based treatments for HR+HER2+ MBC. Herein, we review the development of CDK4/6i in HER2+ BC, discussing current challenges and potential future..."

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

Real-world efficacy and prognostic factors of CDK4/6 inhibitors in HR+/HER2- metastatic breast cancer: a multicenter retrospective study from the Dongting Lake region of China. (PubMed, Transl Breast Cancer Res) - "The most commonly used CDK4/6i were abemaciclib (33.39%), dalpiciclib (28.98%), palbociclib (25.76%), and ribociclib (10.85%). CDK4/6i demonstrates favorable real-world efficacy in HR+/HER2- MBC patients in central China, particularly in the first-line setting. Several clinical factors may aid in treatment selection and risk stratification."

Biomarker • Journal • Real-world evidence • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Study of Neoadjuvant Endocrine Therapy in HR Positive and HER2 Negative Premenopausal Breast Cancer Patients (clinicaltrials.gov) - P2/3 | N=119 | Completed | Sponsor: Tianjin Medical University Cancer Institute and Hospital | Recruiting ➔ Completed | Trial completion date: Sep 2026 ➔ Sep 2025

Trial completion • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2

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 (ChiCTR) - P4 | N=220 | Not yet recruiting | Sponsor: Cancer Hospital of Shandong First Medical University; Cancer Hospital of Shandong First Medical University

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

The synergistic tumor suppressor effect of CDK4/6 inhibitors and BRD4 inhibitors in acute myeloid leukemia. (PubMed, Leuk Res Rep) - "5. SHR6390 and OTX015 Synergistically Inhibit the Growth of AML Xenografts In Vivo."

Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • BRD4

Dalpiciclib in HR+/HER2- ABC (clinicaltrials.gov) - P=N/A | N=103 | Recruiting | Sponsor: RenJi Hospital | Trial primary completion date: Dec 2025 ➔ Jan 2027

Real-world evidence • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Efficacy and safety of Dalpiciclib in the treatment of hormone receptor-positive advanced breast cancer a multicenter observational real-world study (ChiCTR) - P=N/A | N=500 | Recruiting | Sponsor: Harbin Medical University Affiliated Cancer Hospital; Harbin Medical University Affiliated Cancer Hospital

New trial • Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • PGR

A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy. (clinicaltrials.gov) - P3 | N=912 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P3 trial • Breast Cancer • Oncology • Solid Tumor

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

Circulating tumor DNA • Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

Dalpiciclib versus placebo in combination with letrozole or anastrozole as first-line treatment for women with HR+/HER2- advanced breast cancer: prespecified final analysis of progression-free survival of the phase 3 DAWNA-2 trial. (SABCS 2024) - P3 | "The addition of dalpiciclib to letrozole or anastrozole continues to demonstrate PFS benefits with no new safety signals identified after prolonged follow-up, further supporting this regimen as an alternative option in the current treatment landscape for patients with HR+/HER2- advanced breast cancer, regardless of menopausal status."

Clinical • Combination therapy • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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

Dalpiciclib Combined With Pyrotinib and Letrozole in Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer (LORDSHIPS): A Phase Ib Study. (PubMed, Front Oncol) - P1/2 | "The planned dose-expansion phase II study is ongoing. ClinicalTrials.gov, identifier NCT03772353."

Journal • P1 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Leukopenia • Mucositis • Neutropenia • Oncology • Solid Tumor • Stomatitis • HER-2