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Enhertu Phase II trial met primary endpoint
Enhertu Phase II trial met primary endpoint.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 9767A AstraZeneca PLC 27 January 2020 \n\n27 January 2020 07:00 GMT\n \nPhase II DESTINY-Gastric01 trial of Enhertu versus\nchemotherapy met primary endpoint\n \nTrial met primary endpoint of objective response rate and key secondary\nendpoint of overall survival in patients with previously treated HER2-positive metastatic gastric cancer\n \nHigh-level results from the positive registrational Phase II trial DESTINY-Gastric01 showed AstraZeneca's and Daiichi Sankyo Company, Limited (Daiichi Sankyo)'s Enhertu (trastuzumab deruxtecan), achieved a statistically significant and clinically meaningful improvement in objective response rate (ORR) and overall survival (OS) in patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction cancer that had progressed following two or more treatment regimens including trastuzumab and chemotherapy.\n \nThe trial met its primary endpoint of an improvement in ORR, as assessed by an independent review committee, in patients treated with Enhertu compared to investigator's choice of chemotherapy (irinotecan or paclitaxel monotherapy). Enhertu also showed a statistically significant and clinically meaningful improvement in OS, a key secondary endpoint.\n \nJosé Baselga, Executive Vice President, Oncology R&D, said: \"Gastric cancer is usually diagnosed in the advanced stage and patients face markedly high mortality rates, making the need for new therapies especially urgent. Given the previous results seen in our HER2-positive development programme and now in HER2-positive metastatic gastric cancer, we believe this antibody drug conjugate has the potential to redefine the treatment of patients with HER2-expressing cancers.\"\n \nGilles Gallant, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo, said: \"We are excited to report positive top-line results from this trial. Our development plan remains on track in gastric cancer, including an initial regulatory application in Japan where gastric cancer is highly prevalent, and where SAKIGAKE designation has been granted for this indication. We are strongly committed to bringing this therapy as rapidly as possible to patients in need.\"\n \nThe overall safety and tolerability profile of Enhertu in DESTINY-Gastric01 was consi...