AstraZeneca PLC - AZN STOCK NEWS

AstraZeneca highlights its commitment to redefining breast cancer care at the 2021 San Antonio Breast Cancer Symposium, showcasing data from 14 medicines and potential new treatments across 33 abstracts. Key data from the DESTINY-Breast03 trial confirms the efficacy of ENHERTU for HER2-positive metastatic breast cancer. Notable presentations include promising results from BEGONIA and TROPION-PanTumor01 trials, focusing on personalized medicine approaches. The OlympiA trial illustrates the quality of life improvements associated with LYNPARZA for early breast cancer patients. The company emphasizes a diverse portfolio aimed at improving outcomes for breast cancer patients.

Daiichi Sankyo announced the initiation of the DESTINY-Breast11 phase 3 trial, investigating ENHERTU (trastuzumab deruxtecan) as a neoadjuvant therapy for high-risk HER2 positive early-stage breast cancer. This global trial aims to evaluate ENHERTU's efficacy against the current standard of care, assessing its potential to improve patient outcomes while reducing treatment toxicity. Approximately 624 patients will be enrolled across various regions, with a primary focus on achieving a pathologic complete response (pCR) before surgery.

AstraZeneca's supplemental New Drug Application for LYNPARZA^® (olaparib) has been accepted for Priority Review in the US, targeting BRCA-mutated HER2-negative high-risk early breast cancer. The FDA's Priority Review is reserved for drugs that offer significant clinical advantages, with a decision expected in Q1 2022. LYNPARZA demonstrated a 42% reduction in cancer recurrence risk based on the OlympiA Phase III trial. This marks a significant milestone in adjuvant therapy, as breast cancer remains the most diagnosed cancer globally, with 2.3 million cases in 2020.

Tempus announced a multi-year strategic collaboration with AstraZeneca (AZN) to advance oncology drug discovery and development. The partnership aims to leverage Tempus' AI and multimodal data repository to enhance AstraZeneca's research and development efforts. The collaboration seeks to identify novel drug targets and will utilize AI-enabled solutions for better therapeutic outcomes. Both companies expressed optimism about transforming cancer treatment through advanced data analysis.

Daiichi Sankyo has initiated the global TROPION-Breast01 phase 3 trial, assessing the safety and efficacy of datopotamab deruxtecan (Dato-DXd) for treating inoperable or metastatic HR positive, HER2 negative breast cancer. This ADC aims to address significant unmet needs among patients previously treated with chemotherapy, as current therapies show diminished efficacy. Approximately 700 patients will be enrolled across multiple regions globally. The dual primary endpoints focus on progression-free survival and overall survival, marking a pivotal step in oncology development.

AZD7442, AstraZeneca's COVID-19 treatment, demonstrated significant effectiveness in recent studies. The PROVENT trial showed an 83% reduction in symptomatic COVID-19 cases among participants treated with a single 300mg dose, with no severe cases or deaths reported. Meanwhile, the TACKLE trial revealed an 88% decrease in severe COVID-19 or death for patients treated within three days of symptoms. AstraZeneca plans to submit findings for regulatory approval and has already secured agreements for 700,000 doses from the U.S. Government.

AstraZeneca has received Fast Track Designation from the FDA for LOKELMA (sodium zirconium cyclosilicate) to address cardiovascular outcomes related to arrhythmia in patients on chronic hemodialysis with recurrent hyperkalemia. This decision underlines the potential of LOKELMA to mitigate life-threatening cardiovascular risks in this population, which is currently under investigation in the Phase III DIALIZE-Outcomes trial. Hyperkalemia significantly impacts 24% to 48% of patients with chronic kidney disease, representing a crucial unmet medical need. Results from the trial are expected in 2024.

AstraZeneca presented promising new data on CALQUENCE at the 63rd American Society of Hematology Annual Meeting, focusing on chronic lymphocytic leukemia (CLL). New findings include a three-year follow-up from the ASCEND trial demonstrating CALQUENCE's durable efficacy compared to standards of care. Additionally, a new tablet formulation aims to expand patient eligibility. The emerging pipeline shows potential in developing innovative therapies for hard-to-treat blood cancers, enhancing long-term patient care.

Integral Molecular announced an exclusive worldwide antibody license agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop cancer therapeutics. Integral Molecular will supply highly specific monoclonal antibodies, while AstraZeneca will handle all research and commercial activities. This collaboration aims to enhance personalized cancer treatments and improve patient outcomes. The antibodies were discovered using Integral Molecular's advanced technology platforms, ensuring remarkable specificity and efficacy against challenging cancer targets.