LONDON (dpa-AFX) - Daiichi Sankyo Co., Ltd. (DSKYF.PK) announced Monday that Enhertu (trastuzumab deruxtecan), co-developed and commercialized with British drug major AstraZeneca Plc. (AZN.L, AZN), Plus Pertuzumab showed positive topline results in a phase 3 trial in breast cancer patients.
The results from a planned interim analysis of the DESTINY-Breast09 phase 3 trial showed that Enhertu in combination with pertuzumab demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival or PFS compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment for patients with HER2 positive metastatic breast cancer.
HER2 positive metastatic breast cancer is an aggressive disease driven by overexpression or amplification of HER2 that affects 15% to 20% of patients with metastatic breast cancer. HER2 targeted therapies have improved outcomes, while most patients experience disease progression within two years of first-line treatment with THP, which has been the standard of care for more than a decade.
Enhertu, discovered by Daiichi Sankyo, is a specifically engineered HER2 directed DXd antibody drug conjugate or ADC.
DESTINY-Breast09 is a global, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of ENHERTU either alone or in combination with pertuzumab versus standard of care THP as a first-line treatment in patients with HER2 positive metastatic breast cancer.
The company noted that the PFS improvement was seen across all pre-specified patient subgroups with ENHERTU in combination with pertuzumab. The key secondary endpoint of overall survival was not mature at the time of the planned interim analysis. However, interim OS data showed an early trend favoring the ENHERTU combination compared to THP.
According to Daiichi Sankyo, the second arm assessing ENHERTU monotherapy versus THP remains blinded to patients and investigators and will continue to the final PFS analysis.
The companies will present data from the combination arm of DESTINY-Breast09 at an upcoming medical meeting and will be shared with regulatory authorities.
Susan Galbraith, Executive Vice President, Oncology Hematology R&D, AstraZeneca, said, 'This is the first trial in more than a decade to demonstrate superior efficacy across a broad HER2 positive metastatic breast cancer patient population compared to the current first-line standard of care. This is a significant milestone for patients and sets the foundation for ENHERTU in combination with pertuzumab as an important treatment option in the first-line HER2 positive setting.'
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