Results from the Phase II DESTINY-CRC01 trial of
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.
Colorectal cancer
Colorectal cancer is the third most common cancer and second most common cause of cancer death globally.1
Approximately 25% of patients have metastatic disease at diagnosis, meaning the disease has spread to distant organs, and about 50% of patients with colorectal cancer will eventually develop metastases.3 Overexpression and amplification of HER2, a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast, gastric, lung and colorectal cancers, occurs in approximately 2-5% of all patients with colorectal cancer.2,4 Research indicates that HER2 amplification may be associated with resistance to anti-epidermal growth factor receptor (EGFR)-targeted therapy and shorter survival.4,5
DESTINY-CRC01
DESTINY-CRC01 is a global, Phase II, open-label, multi-centre trial testing the safety and efficacy of Enhertu in patients (n=78) with HER2-expressing, unresectable and/or metastatic colorectal cancer. DESTINY-CRC01 excluded patients with a mutation in the RAS or BRAF gene. The primary cohort of the trial enrolled patients (n=53) with HER2-positive disease (defined as IHC3+ or IHC2+/ISH+). The primary endpoint of the trial is confirmed ORR by independent central review in the primary cohort. ORR, or tumour response rate, represents the percentage of patients whose disease decreased and/or disappears. Secondary endpoints include DCR, DoR, PFS and OS. Two additional exploratory cohorts enrolled patients whose tumours had lower levels of HER2 expression [HER2 IHC2+/ISH- (n=7) and HER2 IHC1+ (n=18), respectively].6
Enhertu
Enhertu (trastuzumab deruxtecan, fam-trastuzumab deruxtecan-nxki in the US) is a HER2-directed antibody drug conjugate (ADC) and is the lead ADC in the oncology portfolio of
Enhertu (5.4mg/kg) is approved in the US and
Enhertu clinical development
A comprehensive development programme is underway globally with six registrational trials evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers including breast, gastric and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.
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Collaboration between AstraZeneca and
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AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. With six new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZeneca's main capabilities, the Company is actively pursuing innovative partnerships and investment that accelerate the delivery of our strategy, as illustrated by the investment in
By harnessing the power of four scientific platforms - Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and ADCs - and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.
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