AstraZeneca Plc (NYSE: AZN) reported dual advances in its oncology portfolio on Tuesday, securing a European Union regulatory approval for its breast cancer treatment and posting positive Phase 3 trial results for a lung cancer combination therapy.

The pharmaceutical major announced that the European Commission approved Enhertu, developed jointly with Daiichi Sankyo, as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer. This authorization follows a positive recommendation from the European Medicines Agency’s medicinal committee.

Enhertu Approval Details

The regulatory decision was based on data from the DESTINY-Breast09 trial. The study showed that the Enhertu combination therapy with pertuzumab reduced the risk of disease progression or death by 44% compared to standard THP therapy.

European regulators are also reviewing Enhertu for residual invasive HER2-positive breast cancer, based on data from the DESTINY-Breast05 study.

Lung Cancer Trial Results

In parallel, AstraZeneca released high-level outcomes from the SANOVO Phase 3 study. The trial evaluated Tagrisso combined with Orpathys in untreated patients with epidermal growth factor receptor-mutated, locally advanced or metastatic non-small cell lung cancer featuring MET overexpression.

The study met its primary endpoint, demonstrating a statistically significant and clinically meaningful progression-free survival benefit over Tagrisso monotherapy. This benefit was observed across both high MET and intention-to-treat patient groups. The combination also showed encouraging clinical trends in overall survival, a secondary endpoint.

AstraZeneca jointly develops Orpathys with HUTCHMED Ltd. (NASDAQ: HCM) but holds sole commercialization rights. Previous studies, including SACHI and SAFFRON, had already established the combination’s clinical benefits, leading to an existing approval in China.

What the Numbers Show

The clinical data highlights a distinct divergence in survival outcomes between the new regimen and standard care. The 13.8-month extension in median progression-free survival (from 26.9 months to 40.7 months) underscores the magnitude of the risk reduction cited in the DESTINY-Breast09 trial.

Market Reaction

AstraZeneca shares were down 0.81% at $160.81 during premarket trading on Tuesday, according to Benzinga Pro data.

AstraZeneca and Amgen announced positive high-level results from the Phase III CROSSING trial for TEZSPIRE (tezepelumab-ekko) in eosinophilic esophagitis (EoE). The drug met both co-primary endpoints at week 24, with efficacy sustained through week 52.

Trial Results

The randomized, double-blind trial evaluated TEZSPIRE administered subcutaneously every four weeks against placebo in adults and adolescents with symptomatic, uncontrolled EoE on maintenance therapy. A total of 368 patients were randomized in a 1:1:1 ratio to receive either a low dose, a high dose, or placebo.

TEZSPIRE demonstrated statistically significant and clinically meaningful improvements across both co-primary endpoints:

• Histologic remission: Defined as peak esophageal eosinophil count ≤6 per high-power field.
• Dysphagia symptoms: Measured by mean change from baseline in the Dysphagia Symptom Questionnaire (DSQ) score.

Improvements were maintained through week 52 for both doses tested. The safety profile was generally consistent with approved indications.

Market Context

EoE is a chronic, progressive epithelial-driven inflammatory disorder affecting more than 470,000 people in the US. Prevalence has increased five-fold since 2009. Nearly half of patients, including adolescents, do not achieve adequate disease control with first-line treatments such as dietary restriction, swallowed topical corticosteroids, or proton pump inhibitors.

What the Numbers Show

TEZSPIRE represents the third epithelial-driven inflammatory disease where the drug has demonstrated clinically meaningful efficacy. It is currently approved for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Since 2021, more than 100,000 patients have been treated with TEZSPIRE for severe asthma globally.

Collaboration Details

AstraZeneca and Amgen share costs and profits equally after AstraZeneca pays a mid-single-digit inventor royalty to Amgen. AstraZeneca leads development; Amgen leads manufacturing. The companies jointly commercialize TEZSPIRE in the US, with Amgen recording sales and AstraZeneca recording its share as Alliance Revenue. Outside the US, AstraZeneca records product sales.

Phase III trials in chronic obstructive pulmonary disease (COPD), named JOURNEY and EMBARK, are ongoing.