Astrazeneca Plc Stock Price, News & Analysis

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.

AstraZeneca’s FARXIGA (dapagliflozin) has received Priority Review status from the FDA for treating chronic kidney disease (CKD) in adults, with or without type 2 diabetes. This review reflects the potential of FARXIGA to significantly improve patient outcomes. The FDA aims for a decision by Q2 2021. In clinical trials, FARXIGA reduced the risk of worsening renal function or cardiovascular death by 39% and overall mortality by 31%. This treatment, already indicated for diabetes and heart failure, has shown promising efficacy according to the DAPA-CKD Phase III trial.

AstraZeneca's TAGRISSO^® (osimertinib) has received approval from the US FDA for adjuvant treatment in adult patients with early-stage EGFR-mutated non-small cell lung cancer (NSCLC) post-tumor resection. The decision was supported by the ADAURA Phase III trial, which showed an 83% reduction in disease recurrence risk for Stage II and IIIA patients. The treatment demonstrated a 89% disease-free survival rate at two years compared to 52% for placebo. TAGRISSO's approval also involved five international health authorities through Project Orbis.

AstraZeneca and Daiichi Sankyo presented updated results from the DESTINY-Breast01 trial for ENHERTU (fam-trastuzumab deruxtecan-nxki), showing continued efficacy in HER2-positive metastatic breast cancer patients. With a median follow-up of 20.5 months, the trial indicated a 61.4% objective response rate (ORR) and a median duration of response of 20.8 months. The median progression-free survival was 19.4 months, and 74% of patients remained alive at 18 months. The treatment demonstrated consistent safety profiles, though 18.5% discontinued due to adverse events. ENHERTU is approved in the US and Japan.

A pooled analysis of 762 CLL patients treated with CALQUENCE (acalabrutinib) monotherapy showed a low incidence of cardiac adverse events (AEs) leading to treatment discontinuation. At a median follow-up of 25.9 months, 17% reported cardiac AEs, with only 0.9% discontinuing treatment due to these issues. The analysis concluded that CALQUENCE has a favorable cardiovascular safety profile, akin to untreated CLL patient populations. AstraZeneca plans further trials for CALQUENCE in CLL, aiming to enhance treatment efficacy and safety.