Corporate Update: Daiichi Sankyo Receives Positive EMA Recommendation for Enhertu + Pertuzumab Combination
Date: 26 July 2026
Daiichi Sankyo Co. Ltd. (DS) has secured a favorable opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) regarding the combination of Enhertu (trastuzumab deruxtecan) and pertuzumab as a first‑line therapy for patients with HER2‑positive metastatic breast cancer (mBC). The recommendation follows the pivotal DESTINY‑Breast09 phase‑III trial, which demonstrated a substantial improvement in efficacy and a safety profile consistent with known data for each component.
Key Findings from DESTINY‑Breast09
| Endpoint | Result |
|---|---|
| Primary efficacy – Risk of disease progression or death | 44 % relative risk reduction versus the standard taxane‑trastuzumab‑pertuzumab regimen (HR = 0.56; 95 % CI 0.47‑0.67) |
| Median progression‑free survival (PFS) | > 3 years (36.7 months vs. 23.2 months in control) |
| Overall response rate (ORR) | 85 % (95 % CI 0.80‑0.90) |
| Median duration of response | 39 months (95 % CI 32‑48) |
| Trial population | 383 randomized patients, predominantly female (≈ 96 %) with confirmed HER2‑positive metastatic disease |
These outcomes represent the most robust evidence to date for first‑line therapy in this setting, surpassing the historical benchmark set by taxane‑based regimens.
Safety Profile
The safety data collected over a median follow‑up of 30 months were consistent with the established profile of each agent:
| Adverse Event (AE) | Incidence (%) | Serious AEs (SAEs) |
|---|---|---|
| Neutropenia | 38 | 12 |
| Hypokalaemia | 26 | 5 |
| Anemia | 22 | 3 |
| Interstitial lung disease (ILD) | 12 (low‑grade in 90 % of cases) | 1 |
| Other notable AEs | – | – |
No new safety signals were identified. Grade ≥ 3 AEs were manageable with standard supportive care measures, and dose modifications were infrequently required. The ILD incidence aligns with historical reports for Enhertu, with no evidence of accelerated progression or fatal outcomes during the study period.
Regulatory Pathway
The CHMP’s positive recommendation will be transmitted to the European Commission for a final decision. Upon approval, Enhertu + pertuzumab would become the first new first‑line therapy for HER2‑positive mBC in the European Union in over a decade. This milestone is expected to influence treatment algorithms, reimbursement policies, and clinical practice guidelines across the region.
Strategic Implications for Daiichi Sankyo
- Portfolio Expansion – The addition of a first‑line indication strengthens DS’s position within the oncology ADC segment, complementing its existing portfolio of DXd‑based agents.
- Global Collaboration – The partnership with AstraZeneca has facilitated harmonized regulatory submissions, enabling simultaneous progress across multiple indications, including adjuvant therapy in early‑stage disease and treatment of HER2‑positive tumors beyond breast cancer.
- Market Presence – EU approval would significantly broaden DS’s market footprint, providing a competitive edge against established HER2‑targeted therapies such as trastuzumab‑emtansine and lapatinib‑based regimens.
Practical Implications for Patients and Healthcare Systems
- Improved Patient Outcomes – The 44 % risk reduction and extended median PFS translate into a clinically meaningful extension of disease control, potentially improving quality of life and reducing symptom burden.
- Safety Management – The predictable safety profile allows for streamlined monitoring protocols, with early detection of neutropenia and ILD being critical to maintain treatment continuity.
- Cost‑Effectiveness Considerations – While the cost of ADCs remains high, the substantial efficacy gains and reduced need for subsequent lines of therapy could offset direct treatment expenses in the long term. Health technology assessment bodies will likely consider both clinical benefit and resource allocation when determining reimbursement.
- Clinical Implementation – Oncology practices will need to adapt infusion infrastructure, laboratory monitoring, and patient education strategies to accommodate the new regimen.
Conclusion
The CHMP’s endorsement of Enhertu + pertuzumab marks a pivotal advancement for Daiichi Sankyo’s oncology strategy and offers a promising new option for patients with HER2‑positive metastatic breast cancer. The robust clinical evidence, coupled with a manageable safety profile, positions this combination as a potential new standard of care in the European market, with far‑reaching implications for treatment pathways, reimbursement frameworks, and patient outcomes.
