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.

AstraZeneca Plc (NYSE: AZN) reported a mix of clinical trial outcomes for its lung cancer treatments on Monday, achieving success in two late-stage studies while discontinuing a third due to missed primary endpoints.

The company secured favorable results for its targeted therapies in the SAFFRON and DESTINY-Lung04 Phase 3 trials. However, it halted the eVOLVE-Lung02 study after an independent review determined the treatment would likely fail to meet its dual primary endpoints in the specified patient cohort.

Favorable Results For Targeted Therapies

In the SAFFRON Phase 3 study, the combination of Tagrisso and Orpathys delivered a clinically meaningful and statistically significant extension in both overall survival and progression-free survival (PFS) against standard platinum-based chemotherapy.

The trial focused on patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who experienced disease progression after earlier Tagrisso therapy. These patients exhibited high MET amplification or overexpression, a frequent resistance mechanism associated with a poor prognosis.

Orpathys is co-developed by AstraZeneca and Hutchmed Ltd (NASDAQ: HCM). The safety profile remained consistent with prior studies, and findings will be shared with global regulatory bodies.

Separately, the DESTINY-Lung04 Phase 3 trial yielded encouraging results for Enhertu as a primary treatment for unresectable, locally advanced, or metastatic HER2-mutant non-squamous NSCLC. The engineered antibody-drug conjugate, jointly developed with Daiichi Sankyo, demonstrated substantial PFS improvements over the global standard of care.

Discontinuation Of eVOLVE-Lung02 Study

AstraZeneca announced it is halting the eVOLVE-Lung02 Phase 3 trial. The study assessed volrustomig combined with chemotherapy as an initial therapy for metastatic NSCLC patients exhibiting PD-L1 expression below 50%.

Following a scheduled review, the Independent Data Monitoring Committee determined the combination would likely fall short of its dual primary endpoints in the PD-L1-negative patient cohort. Consequently, the trial is ending, though no unexpected safety signals emerged.

Other Phase 3 volrustomig evaluations targeting mesothelioma, cervical cancer, and head and neck squamous cell carcinoma will proceed as scheduled.

Market Reaction

AstraZeneca shares were up 0.20% at $156.76 during premarket trading on Monday, according to Benzinga Pro data.