AstraZeneca–Daiichi Sankyo have reported data from the Phase II DESTINY-PanTumor02 clinical trial, where Enhertu (trastuzumab deruxtecan) showed offering survival benefits in patients with HER2-expressing advanced solid tumours.
The international, multi-cohort, open-label, multicentre, trial is assessing the safety and efficacy of Enhertu in patients who were previously treated, have locally advanced, unresectable, or metastatic HER2-expressing solid tumours and are ineligible for curative treatment.
The study enrolled 267 subjects at various trial centres in North America, Asia and Europe.
The confirmed objective response rate (ORR) as evaluated by the investigator is the trial’s primary efficacy endpoint.
Secondary endpoints include safety, tolerability, pharmacokinetics, duration of response (DoR), disease control rate, progression-free survival (PFS) and overall survival (OS).
According to the initial assessment findings from the trial, Enhertu offered clinically meaningful PFS and OS in trial subjects.
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By GlobalDataThe therapy also continued to provide lasting responses in the trial subjects.
Safety issues linked to usage of Enhertu were not reported in the trial with its safety profile found to be in line with previously observed findings.
An antibody drug conjugate (ADC) targeting HER2, Enhertu is being co-developed and marketed by the companies.
AstraZeneca oncology chief development officer and chief medical officer Cristian Massacesi said: “The progression-free survival and overall survival results for Enhertu alongside the continued robust and durable tumour responses seen with further follow up underscore the potential value of this important medicine for patients with HER2-expressing cancers who currently have no targeted treatment options.
“With a high unmet need in these cancers, we are working with health authorities to bring Enhertu to patients with HER2-expressing cancers that could potentially benefit from this medicine as quickly as possible.”
AstraZeneca and Daiichi Sankyo reported positive data from the Phase III DESTINY-Breast03 trial of Enhertu in patients with HER2-positive, unresectable and/or metastatic breast cancer.