Enhertu demonstrated clinically meaningful progression-free survival and overall survival across multiple HER2-expressing advanced solid tumors in DESTINY-PanTumor02 Phase II trial

Enhertu demonstrated clinically meaningful progression-free survival and overall survival across multiple HER2-expressing advanced solid tumors in DESTINY-PanTumor02 Phase II trial

High-level results from the primary analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed Enhertu (trastuzumab deruxtecan) demonstrated clinically meaningful progression-free survival (PFS) and overall survival (OS) in previously treated patients across multiple HER2-expressing advanced solid tumours, two secondary endpoints of the trial.

In the primary analysis, Enhertu continued to show durable responses based on investigator-assessed confirmed objective response rate (ORR), the primary endpoint of the trial, and duration of response (DoR), a secondary endpoint; reinforcing results from an interim analysis of the trial recently presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. 

Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, 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.”

Mark Rutstein, Global Head, Oncology Development, Daiichi Sankyo, said: “These updated results from the DESTINY-PanTumor02 trial are important as we work to reshape the clinical landscape in HER2-expressing advanced cancers, where patients currently have limited treatment options and face a poor prognosis. The overall survival demonstrated by Enhertu in these patients is a significant step forward in the potential to advance current standards of care and offer new options for patients with HER2-expressing cancers.”

The DESTINY-PanTumor02 Phase II trial is evaluating the efficacy and safety of Enhertu in patients with previously treated locally advanced, unresectable, or metastatic HER2-expressing solid tumours not eligible for curative therapy, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic, and other cancers.

The safety profile observed in the primary analysis was consistent with prior data and with other trials of Enhertu with no new safety concerns identified. Interstitial lung disease (ILD) rates and severity were consistent with those observed in other trials of Enhertu, with a low rate of Grade 5 ILD events observed as determined by an independent adjudication committee.

These data will be presented at a forthcoming medical meeting and will support ongoing discussions with global health authorities.

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Source link:https://www.astrazeneca.com/

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