AstraZeneca unveils Zegfrovy deal, lung trial win and Enhertu approval

AstraZeneca PLC on Tuesday announced positive developments across its oncology portfolio, including a new lung-cancer licensing deal, positive trial results and EU approval for Enhertu breast-cancer treatment.

The Cambridge, England-based pharmaceuticals company said it had completed its global licensing agreement with Dizal Pharmaceutical Co for Zegfrovy, an oral epidermal growth factor receptor inhibitor for lung cancer.

The deal, previously announced in July, will see AstraZeneca acquire worldwide rights to develop and commercialise the drug.

AstraZeneca will make an upfront payment of USD600 million to Dizal, with additional payments of up to USD900 million upon achievement of development, regulatory and sales-related milestones, the company said.

The drug is approved in China and the US as a second-line treatment for certain patients with non-small cell lung cancer, with a US launch planned in the fourth quarter.

The company said the deal does not affect its 2026 financial guidance.

Separately, AstraZeneca announced positive results from a phase III trial testing its Tagrisso and Orpathys combination as a first-line treatment for a specific type of lung cancer.

In the Sanovo trial in China, the combination was tested against Tagrisso alone in previously untreated patients with epidermal growth factor receptor-mutated non-small cell lung cancer and MET overexpression.

AstraZeneca said the combination produced a statistically significant and "highly clinically meaningful" improvement in progression-free survival in both patients with high metastatic cancer levels and the broader trial population.

The combination also showed encouraging results for overall survival, although the trial will continue to follow patients.

AstraZeneca said the results could support the use of Orpathys alongside Tagrisso as a first-line treatment for these patients. Detailed results will be presented at a forthcoming medical meeting and shared with regulators.

Professor and leading principal investigator of the trial Yi-Long Wu of the Guangdong Provincial People's Hospital said the finding "offers a powerful new approach" for patients.

In addition, AstraZeneca said its Enhertu combination with pertuzumab had been approved in the EU as a first-line treatment for adults with HER2-positive metastatic breast cancer.

Enhertu is a prescription antibody-drug conjugate used to treat specific types of HER2-positive and HER2-low breast, lung, and gastric cancer.

The approval is based on the Phase III DESTINY-Breast09 trial, which showed the combination reduced the risk of disease progression or death by 44% compared with standard treatment.

Median progression-free survival was 40.7 months with Enhertu and pertuzumab, compared with 26.9 months with standard treatment.

AstraZeneca said the approval makes the combination the first new first-line treatment for HER2-positive metastatic breast cancer in more than a decade.

Following approval, AstraZeneca will pay its collaboration partner Daiichi Sankyo Co Ltd USD100 million in milestone payments.

Shares in AstraZeneca were down 0.9% at £11,866.00 on Tuesday morning in London, while Daiichi Sankyo shares closed 0.1% higher at JPY2,850.50 in Tokyo.

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