Astrazeneca Plc - AZN STOCK NEWS

AstraZeneca announced positive results from a Phase III trial (NCT01554618) evaluating exenatide extended-release 2mg in adolescents aged 10-17 with type 2 diabetes (T2D). The study demonstrated a significant reduction in HbA1c levels compared to placebo, achieving its primary endpoint with a LS mean difference of -0.85% (P=0.012). The treatment was generally well tolerated, with adverse events comparable to adults. This is the first trial of a GLP-1 receptor agonist for this age group, and AstraZeneca has filed for FDA priority review for adolescent use.

PathAI announced its participation in the ASCO Virtual Scientific Program 2021, presenting new data on a quality control tool for HER2 testing in digital pathology images. The presentation includes the poster Machine learning models to quantify HER2 for real-time tissue image analysis in prospective clinical trials (Abstract #3061). Together with AstraZeneca (AZN) and Daiichi Sankyo, PathAI developed ML-based models demonstrating high accuracy in HER2 scoring, consistent with ASCO/CAP guidelines, enhancing testing quality in breast cancer clinical trials.

AstraZeneca's CALQUENCE (acalabrutinib) has shown promising results in the ELEVATE-RR Phase III trial, demonstrating non-inferior progression-free survival (PFS) compared to ibrutinib in chronic lymphocytic leukemia (CLL) patients. Median PFS reached 38.4 months for both arms, with CALQUENCE exhibiting a significantly reduced incidence of atrial fibrillation (9.4% versus 16.0%). Additionally, updated ELEVATE-TN trial results indicated a strong PFS benefit for CALQUENCE in previously untreated patients, achieving 87% PFS at 48 months when combined with obinutuzumab.

AstraZeneca’s IMFINZI® (durvalumab) showed significant five-year overall survival (OS) and progression-free survival (PFS) benefits in the updated PACIFIC Phase III trial for patients with unresectable Stage III non-small cell lung cancer (NSCLC) post-chemoradiation therapy. The estimated five-year OS rate was 42.9% for IMFINZI-treated patients versus 33.4% for placebo. Notably, 33.1% of IMFINZI patients had not progressed, compared to 19% for placebo. IMFINZI represents a major advancement, marking the first new treatment available in decades for this patient group.

AstraZeneca and Merck have announced significant results from the OlympiA Phase III trial, demonstrating that LYNPARZA® (olaparib) significantly improves invasive disease-free survival (iDFS) in patients with germline BRCA-mutated, HER2-negative early breast cancer compared to placebo. Data presented at ASCO 2021 shows a 42% reduction in the risk of invasive breast cancer recurrence, with three-year iDFS rates at 85.9% for LYNPARZA versus 77.1% for placebo. The trial continues to monitor overall survival, with regulatory discussions ongoing to expedite treatment access for eligible patients.

AstraZeneca is set to present significant oncology data at the American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8, 2021. The data involves over 100 abstracts focusing on 21 existing and potential cancer treatments, with highlights on LYNPARZA and IMFINZI showcasing their effectiveness in treating early-stage breast and lung cancers. Notably, the OlympiA trial results demonstrate LYNPARZA's potential as the first PARP inhibitor for adjuvant breast cancer treatment. Data from CALQUENCE and ENHERTU will also emphasize improvements in patient outcomes.

New data from the MELTEMI Phase III extension trial confirms that FASENRA^® (benralizumab) is well-tolerated over five years, with a safety profile consistent with earlier studies in severe asthma patients. Adverse events were similar to placebo, and serious infections were low. Patients on high-dosage inhaled corticosteroids saw asthma exacerbation rates drop significantly, with 87% experiencing zero exacerbations in the final year. FASENRA remains approved in multiple regions as an add-on treatment for severe eosinophilic asthma.

AstraZeneca and Amgen's tezepelumab has demonstrated significant efficacy in the NAVIGATOR Phase III trial for severe asthma patients, showing superiority across all primary and key secondary endpoints compared to placebo. Results include a 77% reduction in annualized asthma exacerbation rates (AAER) in patients with elevated eosinophil counts, and an 85% reduction in hospitalizations. Key secondary endpoints, including lung function and quality of life, also improved significantly. However, the SOURCE Phase III trial did not meet its primary endpoint regarding oral corticosteroid reduction.

Amgen announced that AstraZeneca submitted a Biologics License Application (BLA) for tezepelumab to the FDA. This potential first-in-class treatment aims to address severe asthma, with clinical trials indicating a significant reduction in asthma exacerbations. The pivotal NAVIGATOR Phase 3 trial showed tezepelumab's ability to reduce exacerbation rates regardless of baseline eosinophil counts, making it unique among biologics. Tezepelumab targets thymic stromal lymphopoietin, key in asthma inflammation.

This submission is a step towards offering a transformative treatment for severe asthma patients.