Jan 27, 2020: High-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 considerable and clinically meaningful development in objective response rate (ORR) and overall survival (OS) in patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction cancer that had developed following two or more treatment regimens including trastuzumab and chemotherapy.
The trial met its primary endpoint of an improvement in ORR, as measured by an independent review committee, in patients treated with Enhertu compared to the investigator’s choice of the chemotherapy (irinotecan or paclitaxel monotherapy).
Enhertu showed a statistically important and clinically meaningful improvement in OS, a key secondary endpoint.
Adverse effect: In general, safety and tolerability profile of Enhertu in DESTINY-Gastric01 was reliable with that seen in the published Phase I trial in which the most common adverse actions (≥30 percent, any grade) were haematologic and gastrointestinal that includes neutrophil count decrease, anaemia, nausea and decreased appetite.
Also, there were cases of treatment-related interstitial lung disease (ILD) and pneumonitis, the popular of which were Grade 1 and 2 with two Grade 3 and one Grade 4. No ILD-related deaths (Grade 5) occurred in the gastric patients in the Phase I trial or in the DESTINY-Gastric01 trial.Data from DESTINY-Gastric01 will be presented at a upcoming medical meeting.
In addition to the planned discussion with the Japan Ministry of Health, Labour and Welfare (MHLW), both companies plan to discuss their data with other health authorities.
Recently Enhertu received Accelerated Approval in the US for HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based treatment regimens and the additional global regulatory submissions in HER2-positive metastatic breast cancer are underway.
Enhertu is being jointly developed and commercialised worldwide with AstraZeneca except in the Japan where Daiichi Sankyo maintains exclusive rights.
DESTINY-Gastric01: DESTINY-Gastric01 is the registrational Phase II, open-label, multi-centre trial assessing the safety and effectiveness of Enhertu in 189 patients from Japan and South Korea with HER2-expressing advanced gastric cancer or gastroesophageal junction adenocarcinoma (defined as IHC3+ or IHC2+/ISH+) who have progressed on two or more prior treatment regimens that includes fluoropyrimidine (5-FU) and platinum chemotherapy and trastuzumab.
