On March 27, 2026 Daiichi Sankyo reported ENHERTU (trastuzumab deruxtecan) followed by paclitaxel, trastuzumab and pertuzumab (THP) has been approved in China for the neoadjuvant treatment (before surgery) of adult patients with HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) stage 2 (high risk) or stage 3 breast cancer. This indication was granted conditional approval based on the DESTINYBreast11 phase 3 trial, which showed an improvement in pathologic complete response (pCR) rate. Full approval will depend on whether ongoing adjuvant studies confirm long-term clinical benefit in patients with early or locally advanced breast cancer.
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ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN).
Breast cancer is the second most common cancer in women in China, with approximately 357,000 cases of breast cancer diagnosed and nearly 75,000 deaths in 2022. 1 Approximately one in five cases of breast cancer is considered HER2 positive, a breast cancer subtype which is often associated with aggressive disease and poor prognosis. 2,3 For patients with HER2 positive early breast cancer, reaching a pCR with neoadjuvant treatment is the earliest indicator of improved long-term survival.4 However, approximately half of patients who receive neoadjuvant treatment do not reach pCR, putting them at increased risk of disease recurrence.
The conditional approval of ENHERTU by China’s National Medical Products Administration (NMPA) is based on results from the DESTINY-Breast11 phase 3 trial presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and simultaneously published in the Annals of Oncology.
In DESTINY-Breast11, ENHERTU followed by THP demonstrated a statistically significant and clinically meaningful improvement in pCR rate compared to dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP) in patients with high-risk HER2 positive early-stage breast cancer. The pCR rate with ENHERTU followed by THP was 67.29% compared to 56.25% with ddAC-THP, representing an improvement of 11.17% (95% confidence interval [CI]: 3.95-18.28; p=0.003). Similar improvement in pCR rate was observed across most prespecified subgroups, including hormone receptor positive and negative patients. At the time of the analysis, the secondary endpoint of event-free survival (EFS) was not mature (4.5% maturity at data cut-off). However, an early analysis showed a trend favoring ENHERTU followed by THP versus ddAC-THP (hazard ratio [HR]=0.56; 95% CI: 0.26-1.17). Efficacy results were consistent in the China subgroup.
"In patients with high-risk HER2 positive early-stage breast cancer, effective neoadjuvant treatment is critical to lower the risk of disease recurrence and maximize the chance of cure while potentially enabling less intensive surgery," said Professor Jiong Wu, Secretary of the Party Committee of Fudan University Shanghai Cancer Center and China leading primary investigator of the DESTINY-Breast11 trial. "Findings from DESTINY-Breast11 showed that approximately 67% of patients had a pathologic complete response with ENHERTU followed by THP, suggesting a potential new standard of care in this setting."
"As the first approval of ENHERTU globally for the neoadjuvant treatment of HER2 positive early-stage breast cancer and the first HER2 directed antibody drug conjugate approved in China in this setting, ENHERTU followed by THP offers patients in China a new treatment option with the opportunity to reach a pathologic complete response and the potential for improved long-term outcomes," said Michio Hayashi, China President, Daiichi Sankyo. "This third approval of ENHERTU in the last three months and seventh approval in three years reinforces the rapid progress we are making in bringing ENHERTU to more patients in China, where there is a high incidence of breast cancer and a continued need for new treatment approaches."
"ENHERTU followed by THP is the first treatment regimen in more than a decade to demonstrate a clinically meaningful improvement in pathologic complete response and safety in the neoadjuvant setting for patients with HER2 positive early-stage breast cancer, underscoring the significance of this new approval," said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. "ENHERTU is already an important option in the metastatic setting, and this decision will bring it into earlystage disease where cure is possible."
The safety profile of ENHERTU followed by THP in DESTINY-Breast11 was consistent with the known profiles of each individual therapy with no new safety concerns identified. The most common grade 3 or 4 adverse reactions in patients that received at least one dose of ENHERTU 5.4 mg/kg followed by THP in DESTINY-Breast11 (N=320) were neutropenia (13.8%), diarrhea (5.9%), increased transaminases (5.0%), leukopenia (4.4%), nausea (1.9%), peripheral neuropathy (1.9%) and anemia (1.6%). Grade 5 adverse reactions occurred in 0.3% of patients, including interstitial lung disease (ILD; 0.3%). The most frequent adverse reactions associated with permanent discontinuation were peripheral neuropathy (2.2%), ILD (1.9%) and increased transaminases (1.3%).
An application for ENHERTU followed by a taxane, trastuzumab and pertuzumab (THP) also is under review in the U.S. for the neoadjuvant treatment of patients with HER2 positive early-stage breast cancer based on the results from the DESTINY-Breast11 trial.
About DESTINY-Breast11
DESTINY-Breast11 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of neoadjuvant ENHERTU (5.4 mg/kg) monotherapy or ENHERTU followed by THP compared to ddAC-THP in patients with high-risk HER2 positive early-stage breast cancer.
Patients were randomized 1:1:1 to receive either eight cycles of ENHERTU monotherapy; four cycles of ENHERTU followed by four cycles of THP; or four cycles of ddAC followed by four cycles of THP.
The primary endpoint of DESTINY-Breast11 is rate of pCR (absence of invasive disease in the breast and lymph nodes). Secondary endpoints include EFS, invasive disease-free survival, overall survival and safety.
DESTINY-Breast11 enrolled 927 patients across multiple sites in Asia, Europe, North America and South America. For more information about the trial, visit ClinicalTrials.gov.
About Neoadjuvant HER2 Positive Early Breast Cancer
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 10 More than two million breast cancer cases were diagnosed in 2022, with more than 665,000 deaths globally.10 In China, breast cancer is the second most common cancer in women.1 Approximately 357,000 cases of breast cancer were diagnosed in China in 2022, with nearly 75,000 deaths.1
HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast cancer.3 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer. 3 Approximately one in five cases of breast cancer is considered HER2 positive.2
Approximately one in three patients with HER2 positive early-stage breast cancer is considered high-risk, meaning they are more likely to experience disease recurrence and have a poor prognosis.11 For patients with HER2 positive early breast cancer, reaching pCR with neoadjuvant treatment is the earliest indicator of improved long-term survival.4 However, approximately half of patients who receive neoadjuvant treatment do not reach pCR, putting them at increased risk of disease recurrence.
The current standard of care in the HER2 positive neoadjuvant setting in China consists of a combination regimen of carboplatin, trastuzumab, pertuzumab and a taxane.
(Press release, Daiichi Sankyo, MAR 27, 2026, View Source(5.4%20mg/kg)%20followed%20by%20THP%20is,HER2%20positive%20(IHC%203+%20or%20ISH+)%20stage [SID1234665018])