Introduction: About one-fifth of gastric cancer patients are HER2 positive. For HER2-positive advanced or metastatic gastric cancer, combined chemotherapy plus trastuzumab (an anti-HER2 drug) is the first-line treatment option, which can improve survival after chemotherapy is added. However, treatment options for metastatic patients who progressed after initial treatment with this program are limited, and no other drugs for HER2 are available. Enhertu is an antibody-conjugated drug (ADC) targeting HER2 that has only been approved in recent years.
Stomach cancer
Yesterday, AstraZeneca (AstraZeneca) and Daiichi Sankyo Pharmaceutical (Daiichi Sankyo) jointly announced the treatment of Enhertu(+trastuzuma cancer)/GE der New data, In the DESTINY-Gastric02 phase II trial, Enhertu showed a clinically meaningful and durable response in patients with HER2-positive advanced gastric cancer. The research results have been announced in the latest small oral report at the European Society of Medical Oncology (ESMO) conference in 2021.
DESTINY-Gastric02 is a global, open-label, one-arm, phase II trial designed to evaluate the safety of Enhertu (6.4mg/kg) in the treatment of patients with HER2-positive metastasis and/or unresectable gastric or GEJ adenocarcinoma And efficacy, these patients progressed on or after the treatment regimen containing trastuzumab. The trial enrolled 79 patients at multiple locations in North America and Europe.
In the preliminary analysis of this trial, Enhertu’s first trial specifically targeted Western patients with HER2-positive metastatic gastric cancer or GEJ adenocarcinoma.According to an independent central review (ICR) assessment, Enhertu (6.4 mg/kg) confirmed an overall response rate (ORR) of 38%. In Enhertu-treated patients, 3 cases (3.8%) were observed in complete remission and 27 cases (34.2%) in partial remission.
These results are consistent with the results of the previously registered DESTINY-Gastric01 phase II trial published in the New England Journal of Medicine.
After a median follow-up of 5.7 months, Enhertu's median duration of response (DoR) 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 with a confirmed disease control rate (DCR) of 81% (95% CI; 70.6-89.0) was observed.
Enhertu's overall safety in DESTINY-Gastric02 is the same as seen in DESTINY-Gastric01. The most common grade 3 or higher drug-related treatment emergency adverse events in DESTINY-Gastric02 were anemia (7.6%), neutropenia (7.6%), nausea (3.8%) and fatigue (3.8%) ).
According to the independent adjudication committee, 6 cases (7.6%) have been reported for treatment-related interstitial lung disease (ILD) or pneumonia. Most (83%) were low-grade (grade 1 or 2), and 1 case was grade 5 ( ILD or pneumonia-related death).
Enhertu (trastuzumab deruxtecan)
Enhertu is composed of a HER2 monoclonal antibody that is connected to the topoisomerase I inhibitor payload exatecan derivative via a stable tetrapeptide-based cleavable linker. According to the results of the DESTINY-Gastric01 trial, Enhertu is approved in Israel, Japan and the United States for the treatment of locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in adult patients who have previously received a regimen based on trastuzumab .
Currently, Enhertu is conducting further evaluations in a comprehensive clinical development plan to evaluate the efficacy and safety of a variety of HER2-targeted cancers, including breast, gastric, lung, and colorectal cancer .
During the ESMO conference in 2021, several keynote speeches will show the strength and depth of Enhertu data in a variety of tumor types (including gastric cancer, lung cancer, and breast cancer), enhancing the drug's transformative potential in HER2-targeted cancer therapy .
Note: This article is intended to introduce medical and health research and does not provide any basis for medication. For specific medication guidelines, please consult the attending physician.
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