TOKYO & BASKING RIDGE, N.J. - Daiichi Sankyo and AstraZeneca reported Saturday that their antibody-drug conjugate ENHERTU (trastuzumab deruxtecan) demonstrated a statistically significant improvement in pathologic complete response (pCR) rate in the phase 3 DESTINY-Breast11 trial for patients with high-risk, locally advanced HER2 positive early-stage breast cancer.
The trial showed ENHERTU followed by paclitaxel, trastuzumab and pertuzumab (THP) in the neoadjuvant setting achieved a pCR rate of 67.3% compared to 56.3% with the current standard treatment of dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP), representing an 11.2% improvement (p=0.003).
Improvements were observed across both hormone receptor positive and negative subgroups, with 81.3% of patients in the ENHERTU arm having no or minimal residual invasive cancer after surgery compared to 69.1% in the standard treatment arm.
"For patients with early breast cancer who are at high risk of disease recurrence, using the most effective treatment option at the earliest opportunity is critical," said trial principal investigator Nadia Harbeck, Director of Breast Center at LMU University Hospital in Germany.
The safety profile was favorable compared to standard treatment, with lower rates of grade 3 or higher adverse events (37.5% vs. 55.8%) and serious adverse events (10.6% vs. 20.2%). Interstitial lung disease rates were low and similar between treatment arms.
Ken Takeshita, Global Head of R&D at Daiichi Sankyo, noted that approximately half of patients still show evidence of residual disease following surgery with currently available neoadjuvant treatments, highlighting the significance of the improved outcomes with ENHERTU.
A supplemental Biologics License Application based on these results is currently under review by the U.S. Food and Drug Administration.
The findings were presented at the European Society for Medical Oncology Congress alongside results from the DESTINY-Breast05 trial, further supporting ENHERTU's potential as a foundational treatment in the curative-intent early breast cancer setting. With a robust gross profit margin of 78.5% and revenue growth of 14% over the last twelve months, Daiichi Sankyo continues to demonstrate strong commercial execution. InvestingPro analysis suggests the stock is currently trading below its Fair Value, potentially presenting an opportunity for investors interested in the pharmaceutical sector. For comprehensive analysis and additional insights, investors can access over 10 exclusive ProTips and detailed financial metrics through InvestingPro.
In other recent news, AstraZeneca and Daiichi Sankyo's ENHERTU showed a 92.4% invasive disease-free survival rate over three years in a phase 3 trial for HER2 positive early breast cancer. The trial, presented at the European Society for Medical Oncology Congress, revealed a 53% reduction in the risk of invasive disease recurrence or death compared to trastuzumab emtansine. Additionally, AstraZeneca and Daiichi Sankyo announced promising results for their drug DATROWAY in combination with rilvegostomig for urothelial cancer, with a confirmed objective response rate of 68.2% in untreated patients. In another development, AstraZeneca reported that DATROWAY met its main goals in a phase 3 trial for metastatic triple-negative breast cancer, showing significant improvements in overall and progression-free survival.
Furthermore, the FDA has granted Breakthrough Therapy Designation to raludotatug deruxtecan for certain ovarian and related cancers, a drug being developed by Daiichi Sankyo and Merck. Also, ifinatamab deruxtecan demonstrated a 48.2% response rate in a trial for small cell lung cancer, marking another potential advancement in cancer treatment. These developments reflect ongoing efforts by AstraZeneca and Daiichi Sankyo in the field of oncology, with several drugs showing promising results across different types of cancer.
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