Daiichi Sankyo and AstraZeneca's Enhertu (fam-trastuzumab deruxtecan-nxki) has been honored with The Galien Foundation's 2024 Prix Galien USA Award for Best Biotechnology Product. The award, presented at the American Museum of Natural History in New York, recognizes Enhertu's significant contribution to improving the human condition through innovative biomedical technology.
About Enhertu
Enhertu is a HER2-directed antibody-drug conjugate (ADC) engineered using Daiichi Sankyo’s proprietary DXd ADC Technology. It consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. This design allows for targeted delivery of the cytotoxic payload to HER2-expressing cancer cells.
Clinical Approvals and Indications
Enhertu has secured approvals in over 65 countries for various indications, demonstrating its broad clinical utility:
- HER2-Positive Breast Cancer: Approved (5.4 mg/kg) for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen.
- HER2-Low Breast Cancer: Approved (5.4 mg/kg) for adult patients with unresectable or metastatic HER2-low breast cancer who have received prior systemic therapy.
- HER2-Mutant NSCLC: Approved (5.4 mg/kg) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations and who have received prior systemic therapy.
- HER2-Positive Gastric Cancer: Approved (6.4 mg/kg) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
- HER2-Positive Solid Tumors: Approved (5.4 mg/kg) in the US for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options.
These approvals were based on the results of pivotal trials such as DESTINY-Breast03, DESTINY-Breast04, DESTINY-Lung02, DESTINY-Lung05, DESTINY-Gastric01, DESTINY-Gastric02, DESTINY-Gastric06, DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02.
Ongoing Clinical Development
A comprehensive global clinical development program is underway to evaluate the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers. Trials are also exploring Enhertu in combination with other anticancer treatments, including immunotherapy.
Collaboration and Manufacturing
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize Enhertu in March 2019. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu.
Daiichi Sankyo's ADC Portfolio
Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. Daiichi Sankyo's ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house.
Sunao Manabe, representative director, executive chairperson and CEO of Daiichi Sankyo, stated, "Enhertu is redefining the classification and treatment of metastatic breast cancer to include new segments of eligible patients and is transforming the treatment landscape for HER2 positive solid tumours."
