Enhertu® has received approval in the European Union (EU) as the first tumor agnostic HER2 directed therapy for patients with HER2 positive metastatic solid tumors. The approval allows Enhertu® to be used as a monotherapy for adults with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors.
The treatment is intended for patients who have received previous therapies and have no satisfactory treatment alternatives available. Furthermore, this approval introduces a new targeted treatment approach for patients across multiple cancer types.
Enhertu® is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC). Daiichi Sankyo discovered the therapy, and the company jointly develops and commercializes it with AstraZeneca.
The European Commission granted the approval following a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Moreover, the decision was supported by clinical data from HER2 positive tumor subgroups across three Phase 2 trials.
These studies included DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02. Together, the trials evaluated Enhertu® in patients with different HER2 positive metastatic solid tumors.
Enhertu® Demonstrates Positive Clinical Trial Outcomes
In the DESTINY-PanTumor02 trial, Enhertu® showed a confirmed objective response rate (ORR) of 52.3%. The analysis included 111 previously treated patients with HER2 positive solid tumors.
The patient group included individuals with biliary tract, bladder, cervical, endometrial, ovarian, pancreatic, and other tumor types. Additionally, the median duration of response (DOR) reached 21.1 months.
In the DESTINY-Lung01 trial, Enhertu® demonstrated a confirmed ORR of 52.9%. The results came from 17 previously treated patients with centrally confirmed HER2 positive non-small cell lung cancer (NSCLC).
Furthermore, the median duration of response in this group reached 6.9 months. In the DESTINY-CRC02 trial, Enhertu® achieved a confirmed ORR of 46.9%.
The study involved 64 previously treated patients with centrally confirmed HER2 positive colorectal cancer. The median duration of response reached 5.5 months.
“HER2 overexpression occurs across multiple tumor types and is associated with aggressive disease and a poor prognosis. Until now, HER2 directed therapies were only available for specific tumor types,” said Benedikt Westphalen, MD, Head of the Precision Oncology Program, Comprehensive Cancer Center of the University of Munich, Germany. “The approval of trastuzumab deruxtecan as a tumor agnostic therapy opens a new treatment option for patients with HER2 positive cancers regardless of where the tumor originated.”
Advancing Precision Oncology With HER2 Targeted Treatment
The safety profile of Enhertu® remained consistent across the DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02 studies. Additionally, no new safety concerns were identified during the clinical evaluations.
A pooled safety analysis of patients receiving Enhertu® 5.4 mg/kg across multiple tumor studies reported several Grade 3 or Grade 4 adverse reactions.
These reactions included neutropenia, anemia, fatigue, leukopenia, thrombocytopenia, nausea, lymphopenia, hypokalemia, increased transaminases, diarrhea, vomiting, decreased appetite, pneumonia, and decreased ejection fraction.
Grade 5 adverse reactions occurred in 1.1% of patients. This included interstitial lung disease/pneumonitis in 1.0% of patients.
“This approval of Enhertu marks a significant milestone in the EU for patients with HER2 positive metastatic solid tumors and establishes the first tumor agnostic indication for a HER2 directed therapy and antibody drug conjugate in the region,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “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.”
“Precision medicine is reshaping cancer care by helping inform treatment decisions based on the molecular and biological characteristics of a patient’s disease,” said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. “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 tumor 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.”
Enhertu® 5.4 mg/kg is currently approved in more than 40 countries and regions worldwide. The approval covers adults with unresectable or metastatic HER2 positive (IHC 3+) solid tumors.
The treatment availability is based on efficacy results from DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02, and HERALD clinical trials. Therefore, Enhertu® continues expanding its role in precision oncology and targeted cancer treatment.
Explore Health Tech Insiders for the latest medical innovations and reliable strategic insights driving the future of technology-driven healthcare transformation.
News Source: Businesswire.com
