AstraZeneca ENHERTU improves PFS in Phase III

• AstraZeneca and Daiichi Sankyo said ENHERTU significantly improved progression-free survival versus standard first-line therapy in the Phase III DESTINY-Lung04 trial.
• AstraZeneca ADRs were down 0.5% at $156.45 in pre-market trading amid several same-day lung cancer pipeline updates.
• The companies plan to present detailed results at a medical meeting and share the data with global regulators while overall survival continues to be assessed.

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo said ENHERTU significantly improved progression-free survival versus standard first-line treatment in the Phase III DESTINY-Lung04 lung cancer trial.

The trial compared ENHERTU with platinum-pemetrexed chemotherapy plus pembrolizumab in patients with unresectable, locally advanced or metastatic HER2-mutant non-squamous NSCLC, a mutation found in about 2%–4% of NSCLC cases.

“DESTINY-Lung04 becoming the first Phase III trial to demonstrate a progression-free survival benefit versus the global standard of care,” said AstraZeneca Executive Vice President, Oncology Haematology R&D Susan Galbraith.

The trial will continue evaluating secondary endpoints including overall survival, while the companies said ENHERTU's safety profile remained consistent with its known profile and showed no new safety concerns.

AstraZeneca and Daiichi Sankyo plan to present the data and share it with global regulators.

Following the announcement, AstraZeneca's share price was down 0.5% at $156.45 in U.S. pre-market trading.

ENHERTU is already approved in the U.S. for previously treated unresectable or metastatic NSCLC with activating HER2 mutations, with that indication granted under accelerated approval.

Daiichi Sankyo discovered the HER2-directed DXd antibody-drug conjugate, while AstraZeneca and Daiichi Sankyo jointly develop and commercialize ENHERTU across multiple cancer indications.