AstraZeneca Plc (NYSE:AZN) on Monday reported a mix of clinical trial outcomes for its lung cancer treatments, achieving notable successes in two late-stage trials while discontinuing a third study due to missed primary endpoints.
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.
This 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.
According to the data, these patients exhibited high MET amplification or overexpression, a frequent resistance mechanism associated with a poor prognosis.
The safety profile remained consistent with prior studies, and findings will be shared with global regulatory bodies.
Orpathys is co-developed by AstraZeneca and HUTCHMED Ltd (NASDAQ:HCM).
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
On Monday, AstraZeneca said 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.
Meanwhile, other Phase 3 volrustomig evaluations targeting mesothelioma, cervical cancer, and head and neck squamous cell carcinoma will proceed as scheduled.
AZN Stock Price Activity: AstraZeneca shares were up 0.20% at $156.76 during premarket trading on Monday, according to Benzinga Pro data.
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