AstraZeneca (LSE:AZN) has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for Enhertu as a monotherapy in adult patients with unresectable or metastatic HER2‑positive (IHC 3+) solid tumours who have received prior treatment and have no satisfactory treatment options.
The CHMP based its recommendation on subgroup data from three Phase II trials, DESTINY‑PanTumor02, DESTINY‑Lung01 and DESTINY‑CRC02, in which Enhertu showed confirmed objective response rates of 51.4% (n=111) with a median duration of response of 14.2 months in DESTINY‑PanTumor02, 52.9% (n=17) with a 6.9‑month DOR in DESTINY‑Lung01, and 46.9% (n=64) with a 5.5‑month DOR in DESTINY‑CRC02, and the safety profile was consistent with prior studies.
"This positive CHMP opinion underscores the importance of precision oncology and marks an important step toward bringing a new targeted option to more patients in the EU living with HER2‑positive solid tumours," said Susan Galbraith, Executive Vice President, Oncology Haematology R&D at AstraZeneca.
Enhertu already holds a tumour‑agnostic approval in the US and other countries based on DESTINY‑PanTumor02 and additional EU submissions are under review, including combinations with pertuzumab in first‑line HER2‑positive breast cancer (DESTINY‑Breast09) and for residual invasive disease after neoadjuvant therapy (DESTINY‑Breast05).
Enhertu is a HER2‑directed DXd antibody‑drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
