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‘Excitement’ around new data for Enhertu

New analyses from the DESTINY-Breast03 trial shows Enhertu is effective against metastatic HER2-positive breast cancer in specific patient subgroups including those with stable brain metastases


The discovery in the early 1980s that the mutated gene HER-2 could stimulate excessive cell growth and division transformed the treatment of cancer, leading to the development of trastuzumab (Herceptin) and launching the era of targeted drug therapy.

Decades later, trastuzumab remains a core part of standard treatment for breast cancer, usually in combination with chemotherapy in first-line.

However, despite initial treatment with trastuzumab and a taxane, patients with HER2-positive metastatic breast cancer will often experience disease progression, including brain metastases, which affect between 30% and 50% of patients.

While HER2 therapies can improve systemic disease control, prognosis following the development of brain metastases remains poor.

However, recent developments in the use of antibody-drug conjugates (ADC) involving trastuzumab are offering hope to women with metastatic breast cancer. These include data from AstraZeneca’s DESTINY-Breast03 phase 3 trial that showed its ADC Enhertu (trastuzumab deruxtecan) reduced the risk of disease progression or death by 72% compared to trastuzumab emtansine (T-DM1).

In the trial, nearly all patients treated with Enhertu were alive at one year (94.1%) compared to 85.9% of patients treated with T-DM1.

These primary data from DESTINY-Breast03 led to Enhertu – jointly developed by AstraZeneca and Daiichi Sankyo – receiving its fourth breakthrough therapy designation (BTD) in the US in September 2021 for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.

Building on this, this week AstraZeneca has presented additional analyses from DESTINY-Breast03 focusing on specific patient subgroups including those with stable brain metastases.

These analyses show that Enhertu demonstrated a higher progression-free survival (PFS) and objective response rate (ORR) in pre-specified patient subgroups including patients defined by stable brain metastases, hormone receptor status, number of prior lines of therapy, prior pertuzumab treatment or status of visceral metastasis.

“The main goals in the treatment of HER2-positive metastatic breast cancer, including those with stable brain metastases are to improve symptoms, stabilise or reduce the tumour size and improve overall survival,” said Professor Sara Hurvitz, director of the Breast Cancer Clinical Trials Program at the David Geffen School of Medicine at University of California, Los Angeles.

“The higher progression-free survival seen in DESTINY-Breast03 in the subgroup of patients with stable brain metastases are encouraging, and underscores the excitement around another potential treatment option for patients who have experienced disease progression on currently available therapies,” said Professor Hurvitz.

Ken Takeshita, R&D head at Daiichi Sankyo added that the additional analyses illustrated “the potential of this treatment to become the new standard of care in patients with previously treated HER2-positive metastatic breast cancer. These data will support our ongoing conversations with global health authorities to realise our commitment to bring Enhertu to patients with previously treated HER2-positive breast cancer earlier in the metastatic setting”.

As part of a comprehensive clinical development programme, Enhertu is being evaluated across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers.

Article by
Hugh Gosling

10th December 2021

From: Research



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