Enhertu demonstrated clinically meaningful and durable response in patients with HER2-positive advanced gastric cancer in DESTINY-Gastric02 Phase II trial

Sep 22, 2021

Detailed results from the positive Phase II DESTINY-Gastric02 trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) HER2-directed antibody drug conjugate (ADC), provided a clinically meaningful and durable tumour response in patients with HER2-positive metastatic and/or unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma previously treated with a trastuzumab-containing regimen. Results were presented during a late-breaking mini-oral presentation at the European Society for Medical Oncology (ESMO) Congress 2021.

Gastric cancer is associated with a poor prognosis, particularly in the advanced stages of the disease, with only 5% to 10% of metastatic patients surviving five years globally. Approximately one in five gastric cancers are HER2-positive.

In the primary analysis of DESTINY-Gastric02, the first trial of Enhertu specifically in Western patients with HER2-positive metastatic gastric cancer or GEJ adenocarcinoma, Enhertu (6.4 mg/kg) demonstrated a confirmed overall response rate (ORR) of 38% as assessed by independent central review (ICR). Three (3.8%) complete responses (CR) and 27 (34.2%) partial responses (PR) were observed in patients treated with Enhertu.

These results were consistent with those from the registrational DESTINY-Gastric01 Phase II trial previously published in The New England Journal of Medicine.

After a median follow-up of 5.7 months, the median duration of response (DoR) of Enhertu was 8.1 months (95% CI 4.1-NE). The median progression-free survival (PFS) was 5.5 months (95% CI 4.2-7.3). An exploratory endpoint of confirmed disease control rate (DCR) of 81% (95% CI; 70.6-89.0) was seen.

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