EMA Recommends Approval of Datopotamab Deruxtecan for Advanced Breast Cancer Patients
the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has recommended the approval of datopotamab deruxtecan, a groundbreaking antibody-drug conjugate (ADC), for adult patients with inoperable or metastatic hormone receptor-positive (HR+) and HER2-negative breast cancer. This recommendation is based on the promising results of the TROPION-Breast01 Phase 3 study, which demonstrated critically important clinical benefits compared too standard chemotherapy.
A new Hope for Advanced Breast Cancer patients
Datopotamab deruxtecan, a conjugate antibody-drug, has shown remarkable efficacy in reducing the risk of disease progression or death by 37% compared to chemotherapy. The study revealed a median progression-free survival (PFS) of 6.9 months for patients treated with the ADC, versus 4.9 months for those receiving chemotherapy.
Beyond PFS, the ADC also achieved a higher objective response rate (ORR) of 36.4%, compared to 22.9% in the chemotherapy group. Additionally, the median duration of response (DOR) was 6.7 months for the ADC arm, surpassing the 5.7 months observed in the chemotherapy arm.The disease control rate (DCR) at 12 weeks was also significantly higher at 75.3% for ADC-treated patients, compared to 63.8% for those on chemotherapy.
Key Findings from the TROPION-Breast01 Study
The TROPION-Breast01 study was an open-label, randomized Phase 3 trial involving 732 patients with inoperable or metastatic HR+/HER2-negative breast cancer. Participants were randomized to receive either datopotamab deruxtecan (6 mg/kg intravenously every three weeks) or investigator-chosen chemotherapy, including eribulin, capecitabine, vinorelbine, or gemcitabine.
Patients were stratified based on the number of prior chemotherapy lines, geographical region, and previous exposure to CDK4/6 inhibitors. The primary endpoints were PFS and overall survival (OS), while secondary endpoints included ORR, DCR, DOR, and time to subsequent treatments or disease progression.
Although OS data were not yet mature at the time of publication,interim results indicated a favorable trend for the ADC,with a hazard ratio of 0.84, suggesting a potential survival benefit over chemotherapy.
Long-Term Benefits and Improved Outcomes
The study also highlighted improvements in other key metrics, such as time to first subsequent therapy or death (TFST), time to second subsequent therapy or death (TSST), and time to second progression or death (PFS2). These findings underscore the long-term advantages of datopotamab deruxtecan as a treatment option for advanced breast cancer patients.
safety and Tolerability Profile
The median treatment duration with datopotamab deruxtecan was 6.7 months, compared to 4.1 months with chemotherapy.Treatment-related adverse events (TRAEs) were observed in 93.6% of ADC-treated patients and 86.3% of those on chemotherapy.Notably, only 2.8% of ADC patients experienced Grade 3 or higher TRAEs, compared to 44.7% in the chemotherapy group.
Common side effects associated with the ADC included nausea (51.1%), stomatitis (50%), alopecia (36.4%), fatigue (23.6%), and dry eyes (21.7%). Severe TRAEs were reported in 5.8% of ADC patients and 9.1% of chemotherapy patients. Dose reductions or interruptions due to TRAEs occurred in 20.8% and 11.9% of ADC-treated patients, respectively, compared to 30.2% and 24.5% in the chemotherapy group.
A milestone in Cancer Treatment
This positive recommendation by the CHMP marks a significant step toward the approval of datopotamab deruxtecan in Europe, following its recent approvals in the united States and Japan.
| Key Metrics | Datopotamab Deruxtecan | Chemotherapy |
|——————————–|—————————-|——————|
| Median PFS | 6.9 months | 4.9 months |
| Objective Response Rate (ORR) | 36.4% | 22.9% |
| Median Duration of Response | 6.7 months | 5.7 months |
| Disease Control Rate (DCR) | 75.3% | 63.8% |
| Grade 3+ TRAEs | 2.8% | 44.7% |
For more details on the latest advancements in antibody-drug conjugates, visit this detailed resource.
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this recommendation brings hope to countless patients battling advanced breast cancer, offering a safer and more effective treatment option.