Enhertu demonstrated clinically meaningful and durable responses in patients across multiple HER2-expressing advanced solid tumours

Positive results from an interim analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed that Enhertu (trastuzumab deruxtecan) demonstrated clinically meaningful and durable responses across a broad range of HER2-expressing advanced solid tumours in previously treated patients.

These results will be presented today as a late-breaking oral presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract #LBA3000).

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

In the trial, previously treated patients (2 median prior lines of therapy) with HER2-expressing advanced solid tumours including either biliary tract, bladder, cervical, endometrial, ovarian and pancreatic cancers or other tumours treated with Enhertu showed a confirmed objective response rate (ORR) of 37.1%, as assessed by investigator at an interim analysis. A greater response was observed in patients with the highest level of HER2 expression (immunohistochemistry (IHC) 3+), where Enhertu demonstrated a confirmed ORR of 61.3% as confirmed by central testing. A complete response (CR) was observed in 15 (5.6%) patients in the overall trial population, with 84 (31.5%) partial responses (PR) observed, and 123 (46.1%) patients achieving stable disease. The disease control rate (DCR) in the overall trial population was 68.2%, as assessed by investigator.

Nearly half (49.6%) of all patients in DESTINY-PanTumor02 who achieved a response remained in response at one year. Median duration of response (DoR) was 11.8 months (95% confidence interval [CI] 9.8-NE) in the overall trial population and 22.1 months (CI 9.3-NE) in patients with IHC 3+ expression.

Funda Meric-Bernstam, MD, Chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, US and principal investigator for the trial, said: “The DESTINY-PanTumor02 data showed encouraging and durable response rates across a broad range of HER2-expressing solid tumours where there are currently no approved HER2-targeted treatments. Based on these results, Enhertu has the potential to benefit specific patients with HER2-expressing advanced disease who currently have limited options and may face a poor prognosis.”

Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said: “While HER2 is an established biomarker in breast, gastric, lung and colorectal cancers, data from the DESTINY-PanTumor02 trial validate HER2 as an actionable biomarker across a broad range of tumour types. Enhertu is the first treatment to demonstrate broad activity across HER2-expressing solid tumours where there are currently no approved HER2-directed therapies. These data will support our ongoing conversations with global health authorities as we look to bring Enhertu to as many patients as possible.”

Mark Rutstein, MD, Global Head, Oncology Development, Daiichi Sankyo, said: “Nearly half of patients who achieved a response with Enhertu as a late-line treatment for HER2-expressing advanced solid tumours in DESTINY-PanTumor02 remained in response at one year, demonstrating the potential of this important medicine to provide benefit to patients with hard-to-treat cancers in need of new options. The results further reinforce the important role of antibody drug conjugates like Enhertu to provide potential new solutions to advance current standards of care in areas of high unmet need and improve the outcomes of patients.”

Summary of results: DESTINY-PanTumor02

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