AstraZeneca and Daiichi Sankyo announced that the European Medicines Agency's committee has recommended approval of Enhertu for adult patients with unresectable or metastatic HER2-positive solid tumors.
The recommendation is based on results from three Phase II trials: DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02.
In DESTINY-PanTumor02, Enhertu showed a confirmed objective response rate of 51.4% and median duration of response of 14.2 months in patients with IHC 3+ solid tumors.
In DESTINY-Lung01, the response rate was 52.9% with median duration of 6.9 months in IHC 3+ non-small cell lung cancer.
In DESTINY-CRC02, the response rate was 46.9% with median duration of 5.5 months in IHC 3+ colorectal cancer.
The safety profile was consistent with previous trials, with no new safety concerns identified.
If approved, Enhertu would be the first HER2-directed therapy to receive a tumor agnostic indication in the EU.
The drug already has tumor agnostic approval in the US and other countries based on the DESTINY-PanTumor02 trial.
