Enhertu gains EU approval as the first tumour-agnostic HER2-directed therapy and antibody drug conjugate for patients with previously treated HER2-positive metastatic solid tumours

AstraZeneca and Daiichi Sankyo’s Enhertu has recently secured approval in the European Union as a monotherapy for adults with unresectable or metastatic HER2-positive solid tumours, defined by immunohistochemistry scoring of 3+, who have already undergone prior treatment and for whom no satisfactory alternative options remain.

The European Commission’s decision follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency, and is grounded in results drawn from a subgroup of patients with HER2-positive tumours across three Phase II trials: DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02.

“HER2 overexpression occurs across multiple tumour types and is associated with aggressive disease and a poor prognosis. Until now, HER2-directed therapies were only available for specific tumour types. The approval of trastuzumab deruxtecan as a tumour-agnostic therapy opens a new treatment option for patients with HER2-positive cancers regardless of where the tumour originated,” said Benedikt Westphalen, MD, Head of the Precision Oncology Program, Comprehensive Cancer Center of the University of Munich, Germany.

“Precision medicine is reshaping cancer care by helping inform treatment decisions based on the molecular and biological characteristics of a patient’s disease. Enhertu is already approved in breast, gastric, and lung cancers, and with this approval, clinicians may now consider Enhertu for patients with HER2-positive status across multiple additional tumour types. This highlights the importance of biomarker testing to identify eligible patients and ensure that those with HER2-positive disease are considered for targeted treatment,” said Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca.

“This approval of Enhertu marks a significant milestone in the EU for patients with HER2-positive metastatic solid tumours and establishes the first tumour-agnostic indication for a HER2-directed therapy and antibody drug conjugate in the region. Enhertu is now approved for six indications in the EU, which demonstrates our commitment to advancing innovative medicines in areas of high unmet need to patients with cancer,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc.

Within the DESTINY-PanTumor02 Phase II trial, Enhertu achieved a confirmed objective response rate of 52.3% and a median duration of response of 21.1 months among patients with previously treated IHC 3+ solid tumours, a group encompassing biliary tract, bladder, cervical, endometrial, ovarian, pancreatic, and other tumour types. In DESTINY-Lung01, a confirmed objective response rate of 52.9% was recorded alongside a median duration of response of 6.9 months in patients with previously treated IHC 3+ non-small cell lung cancer. DESTINY-CRC02 yielded a confirmed objective response rate of 46.9% and a median duration of response of 5.5 months among those with previously treated IHC 3+ colorectal cancer.

The safety profile of Enhertu was established through a pooled analysis spanning patients enrolled across DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02, and DESTINY-Breast01, and aligned with what had been observed in earlier clinical work, with no previously unidentified safety concerns arising.

---

---

Related Topics and Keywords

AstraZeneca, enhertu, HER2, HER2-positive metastatic solid tumours