British drug maker AstraZeneca Plc (AZN,AZN.L) and Daiichi Sankyo (DSKYF.PK)
announced Monday that Enhertu (trastuzumab deruxtecan) in DESTINY-PanTumor02 Phase II trial showed clinically meaningful and durable responses across multiple HER2-expressing tumour types.
The positive high-level results from an analysis of the ongoing trial showed Enhertu met the prespecified target for objective response rate or ORR and demonstrated durable response across multiple HER2-expressing advanced solid tumours in heavily pretreated patients.
Enhertu is a specifically engineered HER2-directed antibody drug conjugate or ADC being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
The trial is evaluating the efficacy and safety of Enhertu in patients with locally advanced, unresectable, or metastatic previously treated, HER2-expressing solid tumours not eligible for curative therapy. These include biliary tract, bladder, cervical, endometrial, ovarian, pancreatic, and rare cancers.
The primary endpoint of the trial is investigator-assessed confirmed ORR, while investigator-assessed duration of response or DoR is a key secondary endpoint.
The companies plan to present the trial data at an upcoming medical meeting and to share with global regulatory authorities.
Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said, "Enhertu has already demonstrated its potential to improve outcomes for patients with HER2-targetable breast, gastric and lung cancers, and these positive initial results in other tumour settings with significant unmet need are very encouraging. The DESTINY-PanTumor02 results mark an important step forward in our understanding of the potential role of Enhertu across multiple HER2-expressing tumour types."
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