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JCO announced the efficacy of DS8201 in the treatment of HER2 low expression of gastric/gastroesophageal junction adenocarcinoma
▎ Clinical problems:
About one-fifth of the adenocarcinoma of the gastroesophageal junction adenocarcinoma will experience HER2 overexpression or amplification. The expression levels of HER2 differ in and between tumors and change after anti-HER2 treatment. The effectiveness and safety of DS8201 in the treatment of HER2-low expression of gastroesophageal junction adenocarcinoma is unknown.
A cohort trial result from J Clin Oncol initially proves that DS8201 has clinical benefit in patients with severely treated HER2 low expression of gastroesophageal junction adenocarcinoma.
▎ Study Protocol:
(1) Inclusion Criteria: The subjects were locally advanced and metastatic HER2 low expression (cohort 1 IHC 2+ or in situ hybrid -negative; cohort 2, IHC 1+) patients with gastroesophageal junction adenocarcinoma, who had received at least two regimens, including fluorouracil and platinum drugs, but had not received anti-HER2 treatment; 19 and 21 of the 21 patients in cohort 1 and 24 patients in cohort 2, respectively, had central HER2 confirmation, received T-DXd treatment, and had measurable tumors at baseline;
(2) Subjects received T-DXd 6.4 mg/kg intravenously, once every 3 weeks;
(3) The primary endpoint was the objective response rate (ORR) reviewed by independent centers.
▎ mainly found: 5 cases of
(1) Cohort 1 partially remission, confirmed that the ORR was 26.3% (95%CI, 9.1%-51.2%), and 2 cases of 2 cases of 2 cohort 2 were partially remission, confirm that the ORR was 9.5% (95%CI, 1.2%-30.4%);
(2) Reduction of tumor volume in 13 patients (68.4%) and 12 patients (60.0%) in cohort 2;
(3) The median overall survival (OS) in cohort 1 was 7.8 months (95% CI, 4.7-unpredictable), while the median OS in cohort 2 was 8.5 months (95% CI, 4.3-10.9);
(4) The median progression-free survival (PFS) was 4.4 months (95%CI, 2.7-7.1) in cohort 2, and the median PFS was 2.8 months (95%CI, 1.5-4.3);
(5) The most common grade ≥3 treatment-related adverse events in cohort 1 and cohort 2 were anemia (30.0% and 29.2%), neutrophil count (25.0% and 29.2%), and decreased appetite (20.0% and 20.8%);
(6) In each cohort, there was no drug-related death event.
▎ Outlook:
This study preliminarily demonstrates the effectiveness and safety of DS8201 on the adenocarcinoma of the gastroesophageal junction of HER2, but further research is needed to provide more reliable evidence.
References:
[1]
s://ascopubs.org/doi/full/10.1200/JCO.22.00575
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This article was first published: Medical World Tumor Channel
Author: Dingchao Jingyao Group
Editor: Sweet
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