Enhertu (trastuzumab deruxtecan) has yielded high-level results from the positive registrational Phase II trial – DESTINY-Gastric01 – AstraZeneca and Daiichi Sankyo have announced.
The companies have announced that the drug 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.
They also confirmed that the indication was for patients whose disease had progressed following two or more treatment regimens, including trastuzumab and chemotherapy.
As well as its primary endpoint of an improvement in ORR, 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.
The companies say that the results confirm activity seen in the non-randomised Phase I trial of Enhertu in patients with HER2-positive advanced gastric cancer published in The Lancet Oncology.
Gilles Gallant, senior vice president, 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.”
The drug recently 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 additional global regulatory submissions in HER2-positive metastatic breast cancer are underway.