Dalpiciclib
Dalpiciclib is Hengrui's CDK4/6 inhibitor, the first China-developed drug of the class, approved for hormone-driven advanced breast cancer on the DAWNA trials.
Overview
DAWNA-1 (361 patients, Nature Medicine 2021) showed median progression-free survival of 15.7 versus 7.2 months when dalpiciclib was added to fulvestrant after endocrine therapy (hazard ratio 0.42), the basis of NMPA approval in December 2021; DAWNA-2 with an aromatase inhibitor in the first line followed in 2023. Neutropenia is frequent, as with palbociclib. It gives Chinese patients a reimbursed domestic alternative to imported CDK4/6 inhibitors.
- AmivantamabApproved
- CamizestrantApproved
- Comprehensive genomic profilingStandard of care
- Liquid biopsy (ctDNA)Standard of care
- LorlatinibApproved
- MRD / molecular residual disease testingEstablished
- ADC payload neutralisersPhase 1
- BGB-16673Phase 3
- Bispecific ADCPhase 3
- BRUIN CLL-321Positive
- CaDAnCe-304Recruiting
- CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)Active
- A clone report from blood at every treatment cycle
- A fast route to the matched drug when it is licensed for another cancer
- A multi-cancer platform trial of adaptive (dose-holiday) therapy
- A national rapid research autopsy network for end-stage cancer
- A standard evolvability score for every tumour
- A standing platform trial that assigns treatment by how the tumour escaped
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance atlas: how tumours escape and what closes the route · Lines of therapy.
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Approvals
| Region | Year | Indication |
|---|---|---|
| China | 2021 | HR-positive, HER2-negative advanced breast cancer with fulvestrant after endocrine therapy (DAWNA-1) |
| China | 2023 | First-line HR-positive, HER2-negative advanced breast cancer with an aromatase inhibitor (DAWNA-2) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Dalpiciclib" OR ABSTRACT:"Dalpiciclib" OR TITLE:"Airuikang" OR ABSTRACT:"Airuikang" OR TITLE:"SHR6390" OR ABSTRACT:"SHR6390") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Dalpiciclib, not a curated reading list.
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