AstraZeneca, Daiichi Sankyo report phase 3 Enhertu results

• AstraZeneca and Daiichi Sankyo said Enhertu improved progression-free survival versus standard first-line treatment in the phase 3 DESTINY-Lung04 trial.
• AstraZeneca shares rose 1.4% to £116.20 in early London trading following a broader set of lung cancer pipeline updates.
• The companies plan to present the trial data at a medical meeting and share the results with global regulators.

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo said Enhertu significantly improved progression-free survival versus standard first-line treatment for advanced HER2-mutant non-small cell lung cancer.

The phase 3 DESTINY-Lung04 trial compared Enhertu with platinum-pemetrexed chemotherapy plus pembrolizumab, the current global standard of care for this first-line setting.

“The positive results seen in DESTINY-Lung04 show that treatment with Enhertu in the first-line setting delays disease progression compared to the global standard of care,” said Daiichi Sankyo Global Head of R&D John Tsai.

DESTINY-Lung04 enrolled 454 patients across Asia, Europe and North America, while the trial will continue to assess secondary endpoints including overall survival.

The companies said the results support studying Enhertu earlier in HER2-mutant lung cancer treatment and plan to submit the data to regulators.

Following the announcement, AstraZeneca's share price was up 1.4% at £116.20 in early London trading.

Enhertu is already approved in more than 80 countries and regions for previously treated metastatic NSCLC with activating HER2 mutations and in more than 45 for certain HER2-positive solid tumors.

The randomized trial assigned patients 1:1 to Enhertu at 5.4 mg/kg or standard therapy, with Daiichi Sankyo and AstraZeneca reporting no new safety concerns.