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Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) has shown clinically meaningful 'improvement' in the DESTINY-Gastric04 Phase III trial, regarding the primary endpoint of overall survival (OS) in individuals with gastric or gastroesophageal junction (GEJ) adenocarcinoma.
This global, randomised, open-label trial enrolled 494 subjects in Europe, South America, and Asia.
The trial compared the safety and efficacy of the antibody drug conjugate (ADC) to ramucirumab and paclitaxel in individuals with second-line human epidermal growth factor receptor 2 (HER2) positive unresectable and/or metastatic GEJ adenocarcinoma.
Secondary trial endpoints include duration of response, objective response rate, investigator-evaluated progression-free survival, disease control rate, and safety.
Daiichi discovered the ADC and tailored it leveraging its DXd ADC Technology. It is being developed and commercialised in collaboration with AstraZeneca.
Due to the ADC’s 'superior' efficacy, the Independent Data Monitoring Committee recommended unblinding the study at a planned interim analysis.
DESTINY-Gastric04 claims to be the first Phase III trial to evaluate the ADC in HER2-positive advanced gastric cancer, and its safety profile remains consistent with previous findings.
Daiichi Sankyo R&D global head Ken Takeshita said: “Enhertu is the first HER2 directed medicine to demonstrate an improvement in overall survival in a randomised Phase III trial in the second-line metastatic setting of patients with HER2 positive gastric cancer, reinforcing previous findings seen in our other earlier phase gastric cancer trials.
“With these DESTINY-Gastric04 results, we will work with global regulatory authorities to seek approval in regions where Enhertu is not currently indicated as a second-line option as well as work to secure full approval in regions where Enhertu is conditionally approved.”
The therapy’s current approval in over 65 nations is supported by the DESTINY-Gastric01 Phase II trial and two single-arm Phase II trials, DESTINY-Gastric02 and DESTINY-Gastric06.
In September 2024, AstraZeneca and Daiichi Sankyo reported outcomes from the TROPION-Breast01 Phase III trial of datopotamab deruxtecan (Dato-DXd) for treating breast cancer.
"Daiichi Sankyo and AstraZeneca’s Enhertu shows OS improvements in Phase III trial" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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