AstraZeneca and Daiichi Sankyo have reported positive high-level results from an ongoing analysis of the Phase II DESTINY-PanTumor02 clinical trial of Enhertu (trastuzumab deruxtecan) for solid tumours.

In the trial, the antibody drug conjugate (ADC) demonstrated clinically meaningful and durable responses across multiple HER2-expressing tumour types and met prespecified criteria for objective response rate and duration of response (DoR).

The international, multi-cohort, multicentre, open-label trial is designed for assessing Enhertu’s efficacy and safety at doses of 5.4mg/kg to treat HER2-expressing tumours.

They include bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumours.

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The trial’s primary efficacy endpoint is confirmed objective response rate (ORR) as evaluated by the investigator.

DoR, disease control rate, progression-free survival, overall survival, safety, tolerability, and pharmacokinetics are the secondary endpoints.

Results from the trial analysis demonstrated that Enhertu met the prespecified target for ORR and demonstrated durable responses across multiple HER2-expressing advanced solid tumours in patients who were heavily pretreated.

The specifically engineered HER2-directed ADC Enhertu is being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

AstraZeneca chief medical officer and oncology chief development officer Cristian Massacesi 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.”

In this trial, the safety profile observed in patients treated with Enhertu was found to be consistent with that seen in other trials of the ADC and no new safety signals were identified.​