Key Takeaways:
The European Commission approved AstraZeneca PLC and Daiichi Sankyo's Enhertu as a monotherapy for adults with previously treated unresectable or metastatic HER2-positive solid tumors, the companies' sixth EU indication for the antibody-drug conjugate.
"Until now, HER2-directed therapies were only available for specific tumor types," Benedikt Westphalen, MD, head of the Precision Oncology Program at the Comprehensive Cancer Center of the University of Munich, said. "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."
The approval covers patients with HER2-positive (IHC 3+) tumors who have received prior treatment and lack satisfactory alternatives. In the DESTINY-PanTumor02 trial, 111 patients across biliary tract, bladder, cervical, endometrial, ovarian, pancreatic and other cancers achieved a confirmed objective response rate of 52.3 percent with a median duration of response of 21.1 months. Among 17 patients with HER2-positive non-small cell lung cancer in DESTINY-Lung01, the ORR was 52.9 percent with a median DOR of 6.9 months. In DESTINY-CRC02, 64 colorectal cancer patients showed a 46.9 percent ORR and median DOR of 5.5 months.
The approval establishes Enhertu as the first HER2-targeted therapy and ADC to receive a tumor-agnostic indication in the EU, following a similar US accelerated approval in April 2024. AstraZeneca will pay Daiichi Sankyo $25 million as a milestone payment under their collaboration agreement. Enhertu is now approved for six indications in the EU, including breast, gastric and lung cancers. The European Medicines Agency's Committee for Medicinal Products also recommended approval of Daiichi Sankyo and AstraZeneca's Datroway as a first-line monotherapy for unresectable or metastatic triple-negative breast cancer patients ineligible for PD-1/PD-L1 inhibitors, supported by the Phase 3 TROPION-Breast02 study showing statistically significant improvements in overall survival and progression-free survival versus chemotherapy.
The EU approval expands the addressable patient population for Enhertu beyond tumor-site-specific indications, potentially driving revenue growth for both partners. Investors will watch for additional regulatory decisions on Datroway in China and Japan, as well as ongoing submissions for Enhertu in combination with pertuzumab for first-line HER2-positive breast cancer based on the DESTINY-Breast09 trial.
This article is for informational purposes only and does not constitute investment advice.
