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AstraZeneca PLC (AZN) is a global biopharmaceutical leader focused on oncology, cardiovascular, respiratory, and immunology research. This centralized hub provides verified company announcements, press releases, and market-moving developments from authoritative sources.
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AstraZeneca and Alexion will present 14 studies on amyloidosis therapies at the 2024 International Symposium on Amyloidosis from May 26-30. Key presentations include new subgroup analyses for eplontersen, approved by the FDA in December 2023, and data on ALXN2220 and anselamimab in Phase III trials. The symposium will also feature real-world evidence and patient outcomes from various studies. AstraZeneca aims to advance the science of amyloidosis and improve patient outcomes. Important findings include the use of ALXN2220 for cardiac amyloid removal and the prevalence of phenotypes in ATTR amyloidosis. The company is also seeking regulatory approval for WAINUA in Europe.
Nona Biosciences announced a global license and option agreement with AstraZeneca for the development of monoclonal antibodies into targeted cancer therapies. Under this deal, Nona will receive $19 million initially, with potential milestone payments totaling up to $575 million, and tiered royalties on net sales. Nona may also receive additional payments if AstraZeneca exercises further options. This partnership leverages Nona's antibody discovery platform alongside AstraZeneca's expertise in oncology.
AstraZeneca is set to present new data from its oncology portfolio at the ASCO 2024 Annual Meeting.
Key highlights include results from the LAURA and ADRIATIC Phase III trials of TAGRISSO® (osimertinib) and IMFINZI® (durvalumab) for early lung cancer.
The DESTINY-Breast06 trial will showcase ENHERTU® (fam-trastuzumab deruxtecan-nxki) for HR-positive, HER2-low breast cancer.
Other notable presentations include data on novel therapies like C-CAR031 and updates from I-SPY2.2 Phase II trials.
This reinforces AstraZeneca's commitment to transforming cancer treatment across various stages and types.
AstraZeneca aims to reach $80 billion in total revenue by 2030, up from $45.8 billion in 2023. This growth will be driven by significant expansions in existing oncology, biopharmaceuticals, and rare disease portfolios, alongside the introduction of 20 new medicines by 2030. The company plans to continue investing in transformative technologies for sustained growth beyond 2030. AstraZeneca also targets a mid-30s percentage core operating margin by 2026, with further evolution expected post-2026. Additionally, the company aims to decouple carbon emissions from revenue growth, achieving carbon zero for Scope 1 and 2 emissions by 2026 and halving Scope 3 emissions by 2030.
New data from the Phase IIa COURSE trial suggests TEZSPIRE (tezepelumab) may reduce COPD exacerbations. The trial, involving 337 patients, showed a 17% reduction in annual COPD exacerbation rates compared to placebo, which was not statistically significant. However, in patients with blood eosinophil counts (BEC) ≥150 cells/µL, a significant 37% reduction was noted. For BEC ≥300 cells/µL, the reduction was 46%. Improvements in lung function and quality of life were also reported. Safety profiles were consistent with TEZSPIRE’s use in severe asthma. AstraZeneca and Amgen are planning Phase III trials based on these promising results.
AstraZeneca's CALQUENCE in combination with standard-of-care chemoimmunotherapy demonstrated a significant improvement in progression-free survival in mantle cell lymphoma patients. The trial also showed a favorable trend in overall survival, potentially extending patient survival. The safety profile of CALQUENCE remains consistent with known data, with no new safety concerns identified. The positive results from the ECHO Phase III trial could set a new standard of care for mantle cell lymphoma patients, transforming treatment outcomes earlier in the disease course.
AstraZeneca presents new data for TEZSPIRE and BREZTRI at ATS 2024 focusing on innovative treatments for COPD, severe asthma, and other respiratory diseases. Key highlights include the COURSE Phase IIa trial investigating tezepelumab in COPD patients and the potential of BREZTRI to reduce cardiopulmonary risk in COPD. The PR also covers advancements in asthma treatment, early pipeline science, and real-world evidence in COPD and asthma patients.
ENHERTU demonstrated a significant improvement in progression-free survival in HR-positive, HER2-low metastatic breast cancer patients in the DESTINY-Breast06 Phase III trial. The trial also showed a meaningful improvement in patients with HER2-ultralow expression. The results suggest that ENHERTU could become a new standard of care for this patient population, potentially redefining the treatment of metastatic breast cancer.
The safety profile of ENHERTU was consistent with previous breast cancer clinical trials, with no new safety signals identified. Overall survival data is still pending, but early trends show a potential improvement in patients with HER2-low metastatic breast cancer. The trial will continue to assess other secondary endpoints and further explore the potential of ENHERTU in the treatment landscape.
ENHERTU® Demonstrated Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in HR Positive, HER2 Low Metastatic Breast Cancer Following One or More Lines of Endocrine Therapy in DESTINY-Breast06 Phase 3 Trial
ENHERTU (trastuzumab deruxtecan) has shown positive topline results in the DESTINY-Breast06 phase 3 trial, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard of care chemotherapy in patients with HR positive, HER2 low metastatic breast cancer following one or more lines of endocrine therapy. The trial also revealed a statistically significant and clinically meaningful improvement in PFS in the overall trial population, including patients with HER2 low and HER2 ultralow metastatic breast cancer. Additionally, ENHERTU is expected to become a new standard of care for patients with HER2 low and HER2 ultralow metastatic breast cancer following endocrine therapy, potentially challenging the current treatment paradigms for metastatic breast cancer treatment. The safety profile of ENHERTU remained consistent with previous breast cancer clinical trials.
ENHERTU, a specifically engineered HER2 directed DXd antibody drug conjugate, has displayed promising results in improving patient outcomes and presents a potential shift in the treatment landscape for HR positive, HER2 expressing metastatic breast cancer. The outcomes from DESTINY-Breast06 emphasize the potential for earlier use of ENHERTU in the treatment landscape and highlight the broad patient population that could benefit from this innovative treatment.
