AstraZeneca PLC - AZN STOCK NEWS

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.

Long-term follow-up data from the ACE-LY-004 Phase II trial showed CALQUENCE® (acalabrutinib) effectively treats relapsed or refractory mantle cell lymphoma (MCL). Patients achieved a median progression-free survival of 22 months, with overall survival data still pending after three years. The trial included 124 patients, demonstrating a 28.6% overall response rate and 41.9% estimated duration of response at 36 months. The safety profile remained stable, with 11% discontinuing due to adverse events. CALQUENCE is an important treatment option, particularly as MCL is aggressive and typically diagnosed late.

AstraZeneca is set to present new findings on breast cancer therapies at the 2020 San Antonio Breast Cancer Symposium (SABCS) from December 8-11. Key highlights include updated data from the DESTINY-Breast01 Phase II trial, showcasing ENHERTU's efficacy in HER2-positive metastatic breast cancer, and promising results from the SERENA-1 Phase I trial evaluating AZD9833 in HR-positive, HER2-negative advanced breast cancer. AstraZeneca emphasizes its commitment to improving outcomes for breast cancer patients through innovative treatments and collaborations.

AstraZeneca's IMFINZI® (durvalumab) has received FDA approval for a new 1,500mg fixed dosing option every four weeks for patients with unresectable Stage III non-small cell lung cancer (NSCLC) post-chemoradiation and previously treated advanced bladder cancer. This alternative to the current weight-based dosing aims to improve patient convenience and reduce healthcare visits. This decision follows the FDA's Priority Review status and is based on data from pivotal clinical trials, including the PACIFIC and CASPIAN studies.