AstraZeneca PLC - AZN STOCK NEWS

AstraZeneca's US Phase III trial of AZD1222 shows 79% efficacy in preventing symptomatic COVID-19 and 100% efficacy against severe disease. The interim analysis involved 32,449 participants with 141 symptomatic cases. Notably, the vaccine demonstrated 80% efficacy in participants aged 65 and above. The data safety monitoring board reported no safety concerns, including no increased risk of thrombotic events. AstraZeneca is preparing to submit the data to the FDA for emergency use authorization and plans a broad rollout if approved.

AstraZeneca and Amgen's tezepelumab has shown significant results in the NAVIGATOR Phase III trial, with a 56% reduction in annualized asthma exacerbation rate (AAER) for severe asthma patients compared to placebo. Notably, tezepelumab was effective across various eosinophil counts, achieving a 41% reduction in patients with eosinophil counts <300 cells/μL. The trial demonstrated improvements in lung function, asthma control, and quality of life. Safety results were comparable to placebo, with common adverse events being mild.

AstraZeneca and Merck announced the OlympiA Phase III trial for LYNPARZA (olaparib) has progressed to early primary analysis after a recommendation from the Independent Data Monitoring Committee (IDMC). The trial demonstrated superior efficacy for LYNPARZA versus placebo in improving invasive disease-free survival (iDFS) for patients with germline BRCA-mutated high-risk HER2-negative early breast cancer. The IDMC raised no new safety concerns, and the trial continues to assess key secondary endpoints. This advancement may provide new options for high-risk breast cancer patients.

AliveCor has partnered with AstraZeneca (AZN) to develop innovative disease management solutions in cardiovascular, renal, and metabolism therapeutic areas. This collaboration will utilize AliveCor's potassium detection technology, which allows non-invasive measurement of potassium levels outside of traditional blood tests. The initiative aims to support nearly 30 million U.S. adults with chronic kidney disease, potentially improving patient outcomes and addressing high potassium risks associated with kidney disease.

AstraZeneca's TAGRISSO® (osimertinib) has demonstrated significant disease-free survival (DFS) benefits in the ADAURA Phase III trial for patients with EGFR-mutated non-small cell lung cancer (NSCLC). TAGRISSO reduced the risk of disease recurrence or death by 84% in patients previously treated with chemotherapy and by 77% in those untreated. The trial also showed consistent DFS benefits across disease stages. Following its recent US approval for adjuvant treatment, AstraZeneca aims to expand TAGRISSO's availability globally.

AstraZeneca announced positive results from the ELEVATE-RR Phase III trial of CALQUENCE^® (acalabrutinib) for high-risk chronic lymphocytic leukemia (CLL). The drug demonstrated non-inferior progression-free survival compared to ibrutinib, while showing significantly lower atrial fibrillation rates. With more than 40 months of follow-up, CALQUENCE maintained a favorable safety profile without compromising efficacy. The trial involved 533 patients, and results highlight CALQUENCE's potential in treating CLL, which affects many adults worldwide.

AstraZeneca's ENHERTU® (fam-trastuzumab deruxtecan-nxki) has received FDA approval for treating adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma after prior trastuzumab-based therapy. This marks a significant step forward as only about 5% of patients survive beyond five years after diagnosis. The approval followed the successful DESTINY-Gastric01 Phase II trial, demonstrating a 41% reduction in the risk of death and improved overall survival (12.5 months vs. 8.4 months) compared to chemotherapy.

AstraZeneca will showcase data from its lung cancer treatments at the IASLC 2020 WCLC from January 28-31, 2021. The presentation will feature 39 abstracts, including 11 from its current and pipeline drugs. Notable highlights include updated Phase I data on datopotamab deruxtecan for advanced non-small cell lung cancer (NSCLC) and promising results for ENHERTU in HER2-expressing metastatic NSCLC. The ADAURA Phase III trial data will emphasize TAGRISSO's benefits in early-stage EGFR-mutated NSCLC. AstraZeneca aims to advance early lung cancer detection and treatment during the pandemic.

Recombinetics Inc. announced a collaboration with AstraZeneca to study the treatment of cutaneous neurofibromas associated with Neurofibromatosis Type 1 (NF1) using preclinical models. NF1 affects 1 in 3,000 births, leading to learning disabilities and tumor predisposition. Selumetinib, the first FDA-approved therapy for NF1, will be evaluated in this research. Surrogen's NF1 minipig model mimics the human disease, providing a unique opportunity for treatment exploration. The study aims to enhance understanding and potential therapies for NF1 patients globally.