Enhertu, Jointly Developed, Commercialized By Daiichi Sankyo And Astrazeneca, Recommended For Approval In EU By CHMP As Monotherapy For Treatment Of Adult Patients With HER2 Positive Solid Tumors
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Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options.
Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (NYSE:AZN).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from patients with HER2 positive (IHC 3+) tumors in three phase 2 trials including DESTINY-PanTumor02,DESTINY-Lung01 andDESTINY-CRC02 where Enhertu demonstrated clinically meaningful responses across a broad range of tumors. The recommendation will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU.
In DESTINY-PanTumor02, Enhertu demonstrated a confirmed objective response rate (ORR) of 51.4% (95% confidence interval [CI]: 41.7-61.0) and median duration of response (DOR) of 14.2 months (range: 10.3-23.6) in previously treated patients (n=111) with centrally or locally assessed HER2 positive solid tumors including either biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumors. In DESTINY-Lung01, Enhertu demonstrated a confirmed ORR of 52.9% (95% CI: 27.8-77.0) and median DOR of 6.9 months (range: 4.0-11.7) in previously treated patients (n=17) with centrally confirmed HER2 positive non-small cell lung cancer (NSCLC). In DESTINY-CRC02, Enhertu demonstrated a confirmed ORR of 46.9% (95% CI: 34.3-59.8) and median DOR of 5.5 months (range: 1.3-9.7) in previously treated patients (n=64) with centrally confirmed HER2 positive colorectal cancer.