A British-Swedish pharmaceutical giant that develops and sells prescription medicines for cancer, heart disease, respiratory illness and other conditions, including drugs used by doctors and hospitals worldwide. It was born in 1999 when Sweden's Astra AB merged with Zeneca, the drug and agrochemical arm that Britain's Imperial Chemical Industries had spun off six years earlier. Its name is simply the two companies' names glued together—"Astra" plus "Zeneca."
SAFFRON Phase III trial: Tagrisso plus Orpathys improves PFS and OS in EGFRm lung cancer
Tagrisso (osimertinib) plus Orpathys (savolitinib) showed statistically significant and clinically meaningful improvements in progression-free survival (PFS) and overall survival (OS) versus doublet platinum-based chemotherapy in patients with EGFR-mutated non-small cell lung cancer (NSCLC) with MET overexpression or amplification who progressed on prior Tagrisso.
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SAFFRON is the first global Phase III trial to show significant PFS and OS benefits in this setting, enrolling 338 patients across 230 centres in 29 countries.
The safety profile of the combination was consistent with the known profiles of each medicine, with no new safety findings.
The combination is already approved in China for this patient population based on the SACHI Phase III trial, and the SAFFRON results support global registrations.
Orpathys is jointly developed by AstraZeneca and HUTCHMED and commercialised by AstraZeneca.
AstraZeneca discontinues eVOLVE-Lung02 Phase III trial of volrustomig plus chemotherapy in mNSCLC
The decision follows an Independent Data Monitoring Committee (IDMC) recommendation that the combination was unlikely to meet dual primary endpoints of progression-free survival (PFS) or overall survival (OS) in patients with PD-L1 negative tumours (<1%).
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AstraZeneca is discontinuing the eVOLVE-Lung02 Phase III trial evaluating volrustomig plus chemotherapy as 1st-line therapy in metastatic non-small cell lung cancer (mNSCLC) with PD-L1 <50%.
The safety profile of volrustomig plus chemotherapy was consistent with known profiles of the individual medicines, with no new safety signals identified.
The trial enrolled 895 patients across 25 countries; patients were randomized 1:1 to volrustomig plus chemotherapy or pembrolizumab plus chemotherapy.
Other Phase III volrustomig trials in cervical cancer, head and neck squamous cell carcinoma, and mesothelioma continue as planned.
Enhertu improves PFS in 1L HER2-mutant lung cancer in DESTINY-Lung04 Phase III trial
Enhertu (trastuzumab deruxtecan) showed statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus global standard of care (platinum-pemetrexed doublet chemotherapy plus pembrolizumab) as 1st-line treatment for HER2-mutant advanced non-small cell lung cancer (NSCLC).
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DESTINY-Lung04 is a global, randomized, open-label Phase III trial enrolling 454 patients with unresectable, locally advanced or metastatic HER2-mutant non-squamous NSCLC.
The trial will continue to evaluate secondary endpoints including overall survival; safety was consistent with Enhertu's known profile with no new concerns.
Enhertu is the first and only HER2-directed medicine to improve PFS over global standard of care in a Phase III trial in this first-line setting.
Data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.