AstraZeneca PLC - AZN STOCK NEWS

Initial results from the TROPION-PanTumor01 phase 1 trial for datopotamab deruxtecan (Dato-DXd), jointly developed by Daiichi Sankyo and AstraZeneca, show promising efficacy in heavily pretreated hormone receptor positive, HER2 low or negative metastatic breast cancer. With a 27% objective response rate (ORR) and 85% disease control rate (DCR), the safety profile is consistent with prior studies. Further evaluation is planned in the pivotal TROPION-Breast01 phase 3 trial. These findings underscore the potential of Dato-DXd in addressing unmet needs in this patient population.

AstraZeneca presented SERENA-2 Phase II trial results at the 2022 San Antonio Breast Cancer Symposium. The trial evaluated camizestrant, a next-generation oral selective estrogen receptor degrader, showing a 42% reduction in disease progression risk at 75mg and a 33% reduction at 150mg compared to FASLODEX in post-menopausal patients with ER-positive advanced breast cancer. The median progression-free survival was 7.2 months for 75mg and 7.7 months for 150mg, highlighting camizestrant's potential for improved patient outcomes.

AstraZeneca announced positive results from the Phase III CAPItello-291 trial for capivasertib, an investigational AKT inhibitor, in combination with FASLODEX. This treatment significantly improved progression-free survival (PFS) by 40% in the overall population and 50% in patients with AKT pathway alterations. Median PFS was 7.2 months versus 3.6 months for placebo. The objective response rate (ORR) was 22.9% compared to 12.2% for placebo. Safety profiles were consistent with prior trials. The trial enrolled 708 patients, targeting advanced HR-positive, HER2-low or negative breast cancer.

AstraZeneca and Daiichi Sankyo announced updated results for ENHERTU in the DESTINY-Breast03 Phase III trial, showing a 36% reduction in risk of death compared to T-DM1 in HER2-positive breast cancer patients, with median overall survival not yet reached after 28.4 months. Additionally, ENHERTU demonstrated a 22-month improvement in progression-free survival (PFS) over T-DM1. The safety profile remained consistent with previous trials, with no new concerns. The findings support ENHERTU as the potential new standard of care for previously treated HER2-positive metastatic breast cancer.

Daiichi Sankyo and AstraZeneca presented updated results from the DESTINY-Breast03 trial, showing that ENHERTU significantly improved overall survival (OS) by 36% compared to T-DM1 in HER2 positive metastatic breast cancer patients. The median OS was not reached for ENHERTU versus 34.0 months for T-DM1. Furthermore, ENHERTU offered a 22-month improvement in progression-free survival (PFS) over T-DM1 (28.8 vs 6.8 months), and a confirmed objective response rate of 78.5%. Safety profiles were consistent with prior studies, with grade 3 or higher adverse events in 47.1% of patients receiving ENHERTU.

AstraZeneca showcased 47 abstracts at the 64th American Society of Hematology (ASH) Annual Meeting, emphasizing the efficacy and safety of its hematology portfolio, notably CALQUENCE and new pipeline drugs like TNB-486 (AZD0486). Key data included long-term results and early-stage trials across various blood cancers. CALQUENCE demonstrated a consistent safety profile in chronic lymphocytic leukemia (CLL), while TNB-486 showed potential in relapsed B-cell non-Hodgkin lymphoma. Research on rare diseases was also highlighted, aiming to improve diagnosis and treatment.

AstraZeneca (AZN) and National Resilience, Inc. announced a long-term partnership for biomanufacturing. Resilience will acquire AstraZeneca's facility in West Chester, Ohio, transforming it into a global center for drug product manufacturing. This multi-year supply agreement allows AstraZeneca strategic access to Resilience's manufacturing capabilities. The facility, spanning 580,000 square feet, will enhance the production of various medicines and supports Resilience's mission to ensure broad access to complex treatments, while also retaining over 500 jobs at the site.

AstraZeneca announces strong clinical data to be presented at the 2022 San Antonio Breast Cancer Symposium. The company will showcase its advancements with 12 medicines across 55 presentations, focusing on innovative treatments like capivasertib, an AKT inhibitor, and camizestrant, a next-generation oral SERD. Significant trial results from CAPItello-291 and SERENA-2 demonstrate potential improvements in treatment for HR-positive advanced breast cancer. Additionally, new data on ENHERTU® and datopotamab deruxtecan emphasize AstraZeneca’s commitment to personalized breast cancer therapies.

Alexion, AstraZeneca Rare Disease has completed its acquisition of LogicBio Therapeutics, Inc. (NASDAQ: LOGC), enhancing its capability in genomic medicine. This strategic move leverages LogicBio's unique technology and experienced R&D team, facilitating growth in rare disease therapeutics. The acquisition was finalized on November 16, 2022, following a successful tender offer. LogicBio shareholders will receive $2.07 per share. Frederic Chereau, the CEO of LogicBio, will transition to a senior role within Alexion.