AstraZeneca PLC develops and commercializes prescription medicines across oncology, rare diseases, and BioPharmaceuticals, including cardiovascular, renal and metabolism, respiratory, and immunology. News about AZN commonly covers clinical-trial results, FDA and advisory-committee actions, product approvals, and updates to marketed medicines such as TRUQAP, BREZTRI, SAPHNELO, IMFINZI, IMJUDO, and ULTOMIRIS.
Company updates also address quarterly revenue and earnings trends, alliance and collaboration revenue, licensing transactions for pipeline assets, and governance changes. Recurring development themes include targeted oncology, COPD, asthma, systemic lupus erythematosus, liver cancer, prostate cancer, and rare or immune-mediated diseases.
Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan has gained a positive recommendation from the European Medicines Agency for treating HER2 positive metastatic breast cancer. This recommendation is based on the DESTINY-Breast03 trial, which demonstrated a 72% reduction in disease progression risk compared to T-DM1. The therapy's safety profile aligns with previous studies, and the European Commission will now evaluate this recommendation. With over 530,000 breast cancer diagnoses in Europe annually, there is a critical need for effective treatment options.
ALXN1840, an investigational treatment for Wilson disease, demonstrated significant efficacy in a Phase III trial. The study showed a three-times increase in copper mobilization from tissues compared to standard care (p0.0001). Patients experienced rapid responses by four weeks, sustained for 48 weeks. Notably, initial improvements in neurological scores were observed in symptomatic patients. The treatment was well tolerated, with most adverse events being non-serious. This pioneering approach could redefine management strategies for Wilson disease, which has seen limited innovation for decades.
Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan has received validation from the European Medicines Agency (EMA) for a Type II Variation application. This approval is for treating adult patients with unresectable or metastatic HER2 low breast cancer who have undergone prior systemic therapy. Results from the DESTINY-Breast04 trial indicated significant improvements in progression-free and overall survival compared to standard chemotherapy. The application marks a potential shift in treatment options for patients with low HER2 expression, expanding the reach of targeted therapy.
Results from the PROpel Phase III trial reveal that LYNPARZA (olaparib), in combination with abiraterone, significantly enhances radiographic progression-free survival (rPFS) by 34% for metastatic castration-resistant prostate cancer (mCRPC) patients, regardless of HRR gene mutations. The combination showed a median rPFS of 24.8 months, compared to 16.6 months for abiraterone alone. The data published in NEJM Evidence highlights the need for new first-line treatment options and suggests potential approval for broader patient groups. Safety profiles align with prior trials, indicating no detrimental health effects.
AstraZeneca and Ionis Pharmaceuticals announced positive interim results from the NEURO-TTRansform Phase III trial for eplontersen, a treatment for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). After 35 weeks, the drug met co-primary endpoints, showing significant reductions in serum transthyretin levels and improvements in neuropathy impairment scores. Eplontersen also demonstrated a favorable safety profile and improved quality of life metrics. Following these results, the companies plan to file a New Drug Application with the FDA in 2022.
Daiichi Sankyo announced the dosing of the first patient in the global TROPION-Breast02 phase 3 trial for datopotamab deruxtecan (Dato-DXd). This trial will evaluate the efficacy and safety of Dato-DXd versus chemotherapy in patients with untreated, locally recurrent inoperable or metastatic triple negative breast cancer (TNBC), which constitutes 10-15% of breast cancers. The trial aims to improve survival rates for TNBC patients in need of alternative treatments.
AstraZeneca's Tagrisso® is now part of a clinical trial evaluating EMB-01, a bispecific antibody from EpimAb Biotherapeutics, for non-small cell lung cancer (NSCLC). The U.S. FDA has approved an IND application for a Phase Ib/II study, which intends to assess the safety, pharmacokinetics, and anti-tumor activity of this combination therapy. Dr. Chengbin Wu emphasized the importance of this milestone. The trial aims to tackle the unmet needs of NSCLC patients with EGFR mutations resistant to third-generation TKIs, potentially enhancing treatment options.
AstraZeneca and Daiichi Sankyo's ENHERTU has shown promising results in the DESTINY-Breast04 trial, offering significant improvements in overall survival (OS) and progression-free survival (PFS) for patients with HER2-low metastatic breast cancer. ENHERTU demonstrated a 49% reduction in the risk of disease progression or death compared to chemotherapy, with median PFS of 10.1 months vs. 5.4 months and median OS of 23.9 months vs. 17.5 months. These findings suggest a potential shift in standard treatment for approximately half of breast cancer patients previously considered HER2-negative.
Daiichi Sankyo and AstraZeneca's ENHERTU has shown promising results in the DESTINY-Breast04 trial, enhancing median overall survival by over 6 months compared to chemotherapy for patients with HER2 low metastatic breast cancer. Key findings include a 49% reduction in disease progression or death risk and a median progression-free survival of 10.1 months. The treatment demonstrated a confirmed overall response rate of 52.6%, significantly higher than chemotherapy's 16.3%. The safety profile remains consistent, with most adverse events being manageable.
AstraZeneca announced updates on CALQUENCE® (acalabrutinib) during the ASCO Annual Meeting, showcasing its efficacy and safety in treating chronic lymphocytic leukemia (CLL). The ELEVATE-TN trial results indicated a statistically significant progression-free survival (PFS) benefit, with CALQUENCE combination therapy reducing disease progression or death risk by 89% compared to chlorambucil plus obinutuzumab. Additionally, CALQUENCE showed sustained PFS benefits in the ASCEND trial. Both trials confirmed CALQUENCE's long-term safety profile with no new severe adverse events reported.