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Trastuzumab deruxtecan for patients with HER2-positive tumors (3+ on IHC or 2+ on IHC with a positive FISH)
Source: Gastric Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: February 21, 2025 · Captured 2026-09-09.
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Trastuzumab deruxtecan is an antibody-drug conjugate combining an anti-HER2 antibody with a topoisomerase I inhibitor via a cleavable tetrapeptide-based linker. The U.S. Food and Drug Administration (FDA) approved trastuzumab deruxtecan for patients with locally advanced or metastatic gastric or gastroesophageal junction cancer that is HER2-positive who have previously received a trastuzumab-based regimen.
Evidence (trastuzumab deruxtecan for patients with HER2-positive tumors):
The international, open-label, randomized, phase II DESTINY-Gastric01 trial (NCT03329690) included 187 patients from Japan and South Korea with HER2-positive advanced gastric cancer that had progressed after at least two previous therapies (including trastuzumab). Patients were randomly assigned in a 2:1 ratio to receive either trastuzumab deruxtecan (6.4 mg/kg every 3 weeks) or the physician’s choice of chemotherapy. The primary study end point was objective response.[36]
Source links and citations
The international, open-label, randomized, phase II DESTINY-Gastric01 trial (NCT03329690) included 187 patients from Japan and South Korea with HER2-positive advanced gastric cancer that had progressed after at least two previous therapies (including trastuzumab). Patients were randomly assigned in a 2:1 ratio to receive either trastuzumab deruxtecan (6.4 mg/kg every 3 weeks) or the physician’s choice of chemotherapy. The primary study end point was objective response.[36]
The objective response rate was 51% for patients who received trastuzumab deruxtecan and 14% for patients who received chemotherapy (P < .001).
The international, open-label, randomized, phase II DESTINY-Gastric01 trial (NCT03329690) included 187 patients from Japan and South Korea with HER2-positive advanced gastric cancer that had progressed after at least two previous therapies (including trastuzumab). Patients were randomly assigned in a 2:1 ratio to receive either trastuzumab deruxtecan (6.4 mg/kg every 3 weeks) or the physician’s choice of chemotherapy. The primary study end point was objective response.[36]
The OS was 12.5 months for patients who received trastuzumab deruxtecan and 8.4 months for patients who received chemotherapy (HR, 0.59; 95% CI, 0.39–0.88, P = .02).[36][Level of evidence A1]
Source links and citations
The international, open-label, randomized, phase II DESTINY-Gastric01 trial (NCT03329690) included 187 patients from Japan and South Korea with HER2-positive advanced gastric cancer that had progressed after at least two previous therapies (including trastuzumab). Patients were randomly assigned in a 2:1 ratio to receive either trastuzumab deruxtecan (6.4 mg/kg every 3 weeks) or the physician’s choice of chemotherapy. The primary study end point was objective response.[36]
Common side effects of trastuzumab deruxtecan included neutropenia (grade 3–4 in 51% of patients, with six patients developing neutropenic fever) and anemia (grade 3–4 in 38% of patients). Twelve patients (10%) developed drug-related interstitial lung disease.
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Preserved source evidence · Not medical advice