Enhertu Outperforms Kadcyla in Early Breast Cancer Trial, Positioning for Expanded Use
AstraZeneca and Daiichi Sankyo's antibody-drug conjugate (ADC) Enhertu has demonstrated superior efficacy in early-stage HER2-positive breast cancer, potentially establishing itself as a foundational treatment option in the curative-intent setting. The latest phase 3 trial results, coupled with previous successes, signal a significant advancement in breast cancer therapy and underscore Enhertu's growing importance in the pharmaceutical landscape.
Destiny-Breast05 Trial Results
In the 1,635-patient Destiny-Breast05 trial, Enhertu showed a "highly statistically significant and clinically meaningful improvement" in invasive disease-free survival (IDFS) compared to Roche's Kadcyla (T-DM1). The study focused on patients with HER2-positive early breast cancer at high risk of recurrence who had residual invasive disease following neoadjuvant treatment.
Dr. Susan Galbraith, AstraZeneca's Head of Oncology Hematology R&D, stated, "This landmark trial is the first to directly compare Enhertu and T-DM1 in early breast cancer and the results clearly show that Enhertu delivers superior outcomes, indicating that it may be a better option for patients with high-risk HER2-positive early breast cancer in the post-neoadjuvant setting."
Expanding Enhertu's Reach
The success in Destiny-Breast05 follows earlier positive results from the Destiny-Breast11 trial, where Enhertu demonstrated superiority as a presurgical treatment in patients with high-risk, locally advanced HER2-positive early breast cancer. These combined outcomes position Enhertu for potential expansion into earlier stages of breast cancer treatment.
Enhertu, which entered the market in 2019 as a third-line treatment for HER2-positive breast cancer, has since gained six additional indications. The drug generated sales of $3.75 billion in 2024, reflecting its growing importance in cancer therapy.
AstraZeneca and Daiichi Sankyo plan to present detailed data from both Destiny-Breast05 and Destiny-Breast11 at the upcoming 2025 European Society for Medical Oncology (ESMO) Congress. The companies will also share results with global regulatory authorities, potentially paving the way for new approvals in early-stage breast cancer treatment.
References
- AZ, Daiichi's Enhertu shows early breast cancer prowess with another trial win, topping Roche's Kadcyla
The results, coupled with a prior win, could set up Enhertu to be a "foundational treatment option” in the curative-intent breast cancer setting, AstraZeneca and Daiichi Sankyo said.
Explore Further
What specific clinical data supported Enhertu's superiority in invasive disease-free survival (IDFS) compared to Kadcyla during the Destiny-Breast05 trial?
What are the current sales figures and market positioning of Kadcyla, and how might Enhertu's success impact its competitive standing?
What regulatory hurdles might AstraZeneca and Daiichi Sankyo face in seeking approval for Enhertu in early-stage breast cancer treatment, and what are the expected timelines?
What are the key safety considerations associated with Enhertu's use, particularly in early-stage HER2-positive breast cancer patients?
How does Enhertu's antibody-drug conjugate (ADC) technology differ from other HER2-targeted therapies in terms of mechanism of action and therapeutic benefits?