AstraZeneca Plc (NYSE:AZN) announced major progress across its oncology portfolio on Tuesday, highlighting positive Phase 3 trial results in non-small cell lung cancer alongside a key regulatory approval in the European Union for its metastatic breast cancer treatment.
Positive Phase 3 Lung Cancer Trial Results
The pharmaceutical major reported high-level outcomes from the SANOVO Phase 3 study, which evaluated Tagrisso combined with Orpathys in untreated patients facing epidermal growth factor receptor-mutated, locally advanced or metastatic non-small cell lung cancer with MET overexpression.
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful progression-free survival benefit over Tagrisso monotherapy across both high MET and intention-to-treat patient groups.
The combination therapy also revealed encouraging clinical trends in overall survival, a secondary trial endpoint.
AstraZeneca jointly develops Orpathys alongside HUTCHMED Ltd. (NASDAQ:HCM), while maintaining sole commercialization rights.
Earlier studies, including the SACHI and SAFFRON trials, previously established the combination’s clinical benefits, leading to an existing approval in China.
European Approval Expands Enhertu Indication
Separately, the European Union approved AstraZeneca and Daiichi Sankyo’s Enhertu combination therapy with pertuzumab as a first-line treatment for adults suffering from unresectable or metastatic HER2-positive breast cancer.
The European Commission granted the authorization following a positive recommendation from the European Medicines Agency’s medicinal committee.
This regulatory decision relies on results from the DESTINY-Breast09 trial, where the Enhertu combination slashed the risk of disease progression or death by 44% compared to standard THP therapy.
The regimen extended median progression-free survival to 40.7 months compared to 26.9 months for THP.
European regulators are also reviewing Enhertu for residual invasive HER2-positive breast cancer based on DESTINY-Breast05 study data.
AZN Price Action: AstraZeneca shares were down 0.81% at $160.81 during premarket trading on Tuesday, according to Benzinga Pro data.
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