DATROWAY® Improves Overall and Progression-Free Survival in Metastatic Triple-Negative Breast Cancer
Breakthrough Clinical Results
AstraZeneca and Daiichi Sankyo's DATROWAY® (datopotamab deruxtecan-dlnk) demonstrated statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) compared to chemotherapy in the TROPION-Breast02 Phase III trial. This trial focused on patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option. DATROWAY is the first therapy to significantly improve OS vs. chemotherapy in this patient population. The safety profile was consistent with previous trials. The companies plan to present the data at an upcoming medical meeting and discuss it with regulatory authorities.
Key Highlights
- DATROWAY showed statistically significant and clinically meaningful improvement in overall survival (OS) as 1st-line therapy for patients with metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option.
- DATROWAY also demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS).
- DATROWAY is the first antibody drug conjugate and the only therapy to significantly improve overall survival compared to chemotherapy in patients with metastatic TNBC for whom immunotherapy is not an option.
- The safety profile of DATROWAY was consistent with previous clinical trials in breast cancer.
Recent Studies
Breast Cancer Studies Information
I cannot provide information about recent breast cancer studies based on the available data. The context provided does not contain any information about breast cancer clinical trials, interventions, or outcomes. The available information instead relates to studies on:
- Venetoclax-rituximab for chronic lymphocytic leukemia (CLL) from the MURANO study
- SGLT-2 inhibitors for heart failure, type 2 diabetes, and chronic kidney disease
- Tirzepatide in East Asian participants with type 2 diabetes from the SURPASS trials
None of these studies address breast cancer research, treatments, or clinical outcomes. To provide accurate information about recent breast cancer studies, their interventions, and safety/efficacy outcomes, different source material would be needed.
Drug used in other indications
Datopotamab Deruxtecan-dlnk Trials Beyond Breast Cancer
Non-Small Cell Lung Cancer (NSCLC)
Datopotamab deruxtecan (Dato-DXd) is being actively investigated for non-small cell lung cancer (NSCLC) through several clinical trials:
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TROPION-Lung08: A phase III study evaluating first-line Dato-DXd plus pembrolizumab versus pembrolizumab monotherapy in patients with advanced/metastatic NSCLC without actionable genomic alterations and with PD-L1 tumor proportion score ≥50%
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Intervention model: Two-arm comparison
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Primary endpoints: Progression-free survival and overall survival
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Secondary endpoints: Objective response rate, duration of response, safety and presence of antidrug antibodies
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Trial identifier: NCT05215340
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TROPION-Lung01: A phase 3 study comparing Dato-DXd to docetaxel in pretreated patients with advanced NSCLC
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This was a randomized controlled trial comparing an anti-TROP-2 regimen to docetaxel
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Dato-DXd showed early signals of efficacy, particularly in non-squamous NSCLC and patients with actionable genomic alterations
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Considered a pivotal study in demonstrating efficacy across different patients
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TROPION-PanTumor01: A Phase 1 study evaluating Dato-DXd across multiple tumor types including NSCLC
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This was considered a pivotal study alongside TROPION-Lung01
Efficacy Results in NSCLC
In the TROPION-Lung01 trial, Dato-DXd demonstrated: - Improved objective response rate (ORR) of 26.4% vs. 12.8% compared to docetaxel - Improved progression-free survival (PFS) of 4.4 vs. 3.7 months compared to docetaxel
A systematic review and pooled analysis found that anti-TROP-2 ADCs (including Dato-DXd): - Showed a better safety profile but failed to demonstrate relevant clinical improvement over docetaxel in the general NSCLC population - Demonstrated a statistically significant improvement in overall survival specifically in patients with actionable genomic alterations (HR: 0.63; 95% CI, 0.41-0.95; P = 0.03)
Future Development
Dato-DXd is being further developed for: - Solid tumors where it targets TROP2 on cancer cells - Combination therapy in NSCLC - Neoadjuvant therapy prior to surgery
As of December 9, 2024, marketing applications for datopotamab deruxtecan were undergoing review by at least one regulatory agency, highlighting its potential as a promising ADC in the pipeline for clinical development in non-small cell lung cancer.
