AiRuiKang (dalpiciclib) / Jiangsu Hengrui Pharma - LARVOL DELTA

Triple combination therapy trial for HR+/HER2− breast cancer halts early due to toxicity concerns (News-Medical) - "Dr. Min Yan from the Department of Breast Disease at Henan Cancer Hospital led an investigator-initiated, single-center, open-label phase Ib/II trial to evaluate the triple combination of famitinib, dalpiciclib, and fulvestrant....A total of 46 eligible patients were enrolled. In the phase Ib dose-finding phase (n = 18), the recommended phase II dose (RP2D) was established as famitinib 10 mg daily plus dalpiciclib 100 mg daily in combination with fulvestrant. In the phase II cohort (n = 28), the confirmed objective response rate (ORR) was 51.9% and the disease control rate (DCR) was 92.6%, thereby meeting the prespecified efficacy threshold for the first-stage analysis. However, the median PFS was 15.7 months, which did not demonstrate an advantage over current standard first-line regimens..."

P1/2 data • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

Dalpiciclib combined with endocrine therapy and capecitabine in high-risk HR+/HER2- advanced breast cancer: a multicenter phase II study (ESMO 2026) - No abstract available

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

An Open-label, Single-arm Study of Dalpiciclib in Combination with Aromatase Inhibitor (AI) and Capecitabine as Neoadjuvant Therapy for high-risk HR+/HER2- Early Breast Cancer (ESMO 2026) - No abstract available

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

Outcomes and Toxicity of Concurrent CDK46 Inhibitor and Adjuvant Radiation Therapy in Early Breast Cancer (ASTRO 2026) - "Abemaciclib and radiotherapy appears to be better tolerated than ribociclib or dalpiciclib combined with radiotherapy. Although high grade hematologic toxicities were often observed, but most patients treated with abemaciclib did not modify their treatment during radiotherapy."

Clinical • Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A Phase 1b/2 Study of JS105 in Combination with Dalpiciclib and Fulvestrant in Patients with Advanced Breast Cancer (ESMO 2026) - No abstract available

Clinical • Combination therapy • Metastases • P1/2 data • Breast Cancer • Oncology • Solid Tumor

Dalpiciclib plus Pyrotinib-Based Chemotherapy-Free Regimens as first line treatment in Trastuzumab-Sensitive, HER2-Positive Metastatic Breast Cancer (DAP-HER-02): A Dual-Cohort, Phase II Study (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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

BCTOP-L-M04: Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=145 | Active, not recruiting | Sponsor: Fudan University | Recruiting ➔ Active, not recruiting | Trial primary completion date: Nov 2025 ➔ Jul 2026

Enrollment closed • Trial primary completion date • 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 plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. (PubMed, Lancet Oncol) - P3 | "Our findings suggest that dalpiciclib plus letrozole or anastrozole could be a novel standard first-line treatment for patients with hormone receptor-positive, HER2-negative advanced breast cancer, and is an alternative option to the current treatment landscape."

Journal • Metastases • P3 data • 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

Dalpiciclib Plus Toremifene for First-line Advanced HR Positive and HER2 Negative Breast Cancer (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2026 ➔ Dec 2026

Enrollment open • Trial completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor 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

Dalpiciclib Combined With Aromatase Inhibitors and Olmesartan as the First-line Treatment for HR+/HER2- Advanced Breast Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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

Abiraterone With Dalpiciclib in Salivary Gland Carcinoma (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

New P2 trial • Head and Neck Cancer • Oncology • Salivary Gland Cancer • AR • HER-2

Efficacy and safety of dalpiciclib combined with endocrine therapy in elderly patients with HR+/HER2- advanced breast cancer: a real-world study. (PubMed, Front Oncol) - "Grade 4 adverse events included leukopenia (2.9%), neutropenia (7.1%), and thrombopenia (1.4%). Dalpiciclib plus endocrine therapy possesses acceptable efficacy and safety for the treatment of elderly patients with HR+/HER2- advanced breast cancer."

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

Efficacy and safety of dalpiciclib, exemestane, and goserelin as neoadjuvant therapy in premenopausal HR-positive, HER2-negative breast cancer patients: A phase II clinical trial (ESMO 2024) - P2/3 | "Participants initially received two cycles of TAC (docetaxel, doxorubicin, and cyclophosphamide). Preliminary results advocate for the use of dalpiciclib, exemestane, and goserelin as an effective alternative to continued chemotherapy in premenopausal HR-positive, HER2-negative BC patients unresponsive to initial neoadjuvant chemotherapy. This strategy offers notable treatment benefits, diminishes adverse events, and enhances patient quality of life. Further enrollment up to 43 participants will continue based on these findings."

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

Adebrelimab Combined With Dalpiciclib Isethionate Plus Chemotherapy for Neoadjuvant Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=32 | Not yet recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

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

IN10018 in Combination With Dalpiciclib for Progressive Meningiomas (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Capital Medical University | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Meningioma • Oncology • Solid Tumor

Discovery of rigid linker-based CDK4/6 PROTACs for the treatment of breast cancer. (PubMed, Bioorg Chem) - "In this study, we designed and synthesized a series of novel CDK4/6 PROTACs based on dalpiciclib incorporating rigid linkers...Importantly, P11 showed potential to overcome acquired resistance to CDK4/6 inhibitors. Therefore, P11 could be a promising preclinical candidate for further development."

Journal • Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Targeted Protein Degradation • CDK4 • CRBN

Dalpiciclib combined with endocrine therapy for patients with HR+/HER2- metastatic breast cancer: a multicenter real-world study. (PubMed, Ther Adv Med Oncol) - "In this real-world cohort of HR+/HER2- MBC patients, dalpiciclib plus ET retains its favorable clinical activity. This regimen also showed promising activity in patients with BMs and those previously exposed to CDK4/6 inhibitors."

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

Dalpiciclib with or without Camrelizumab in patients with advanced Intrahepatic Cholangiocarcinoma after failure or intolerance of first-line therapy: A prospective, double-Cohort, phase ?b/? study (ChiCTR) - P1/2 | N=42 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P1/2 trial • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor

Hengrui’s innovative drug Dalpiciclib has achieved the primary endpoint in the Phase III clinical study of adjuvant treatment of HR-positive breast cancer [Google translation] (Jiangsu Hengrui Press Release) - P3 | N=NA | "Recently, Hengrui Medicine's independently developed CDK4/6 inhibitor Dalpiciclib tablets combined with endocrine therapy in the adjuvant treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative female breast cancer achieved statistical significance in the first interim analysis of the primary endpoint (study code: DAWNA-A). The results of the DAWNA-A study showed that Dalpiciclib combined with endocrine therapy can significantly reduce the risk of recurrence and improve the invasive disease-free survival (IDFS) of patients compared with placebo combined with endocrine therapy. The company has recently submitted a pre-marketing communication application to the Center for Drug Evaluation of the National Medical Products Administration."

P3 data: top line • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

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 2028 ➔ Sep 2029 | Trial primary completion date: Dec 2026 ➔ Dec 2027

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

Tolerability of Dalpiciclib vs. Abemaciclib/Ribociclib in Early HR+/HER2- Breast Cancer (clinicaltrials.gov) - P=N/A | N=456 | Not yet recruiting | Sponsor: Henan Cancer Hospital

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