AstraZeneca : Enhertu achieved a tumour response rate of 45.3% in patients with HER2-positive metastatic colorectal cancer in Phase II DESTINY-CRC01 trial

Results from the Phase II DESTINY-CRC01 trial of AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)'s Enhertu (trastuzumab deruxtecan) demonstrated clinically meaningful activity in patients with HER2-positive unresectable and/or metastatic colorectal cancer who received at least two prior lines of standard treatment.

Colorectal cancer is the third most common cancer and second most common cause of cancer death globally.¹ There are currently no medicines approved to specifically treat HER2-positive colorectal cancer, which affects approximately 2-5% of patients with colorectal cancer.²

The primary endpoint of confirmed objective response rate (ORR), assessed by independent central review, showed 45.3% of patients with HER2-positive (defined as IHC3+ or IHC2+/ISH+) advanced colorectal cancer treated with Enhertu monotherapy (6.4mg/kg) achieved a tumour response. A disease control rate (DCR) of 83.0% was observed with a median progression-free survival (PFS) of 6.9 months. Median duration of response (DoR) and overall survival (OS) had not yet been reached at the time of data cut-off.

Salvatore Siena, MD, Professor of Medical Oncology, Department of Oncology and Hemato-Oncology, Università degli Studi di Milano, and Niguarda Cancer Center, Milan, Italy and principal investigator of the DESTINY-CRC01 trial, said: 'Understanding new ways we can treat patients with colorectal cancer, such as targeting HER2, is critical as patients have few remaining treatment options once progression occurs in the advanced disease setting. The results from DESTINY-CRC01 in patients with HER2-positive advanced colorectal cancer are striking and warrant further research, especially considering many of these patients have had numerous prior therapies.'

José Baselga, Executive Vice President, Oncology R&D, said: 'These clinically meaningful and durable responses in patients with advanced HER2-positive colorectal cancer support our belief that HER2 is an important treatment target in this disease. Enhertu has now demonstrated impressive clinical activity in four different cancer settings, reinforcing the potential of this remarkable medicine to transform patient outcomes across a range of HER2-targetable tumours.'

Antoine Yver, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo, said: 'Metastatic colorectal cancer has a devastating prognosis and there have been limited treatment advances following progression on 1st-line treatment and there are no therapies approved that specifically target HER2. We are encouraged by the tumour response rates seen in patients with previously treated advanced colorectal cancer and we will continue to explore the potential of Enhertu to address this unmet medical need.'

Summary of results