Astrazeneca Plc Stock Price, News & Analysis

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.

Daiichi Sankyo and AstraZeneca announced that the European Medicines Agency's CHMP has recommended approval of ENHERTU for treating advanced HER2 positive gastric cancer. This approval is based on positive results from the DESTINY-Gastric02 and DESTINY-Gastric01 trials, showing improved overall survival and response rates over chemotherapy. ENHERTU demonstrated a confirmed objective response rate of 41.8% in DESTINY-Gastric02 and 51.3% in DESTINY-Gastric01, with median overall survival reaching 12.1 months and 12.5 months, respectively. The European Commission will review this recommendation for final approval.

AstraZeneca's IMFINZI and IMJUDO combination therapy has received FDA approval for treating Stage IV non-small cell lung cancer (NSCLC) based on findings from the POSEIDON Phase III trial. This combination resulted in a 23% reduction in mortality risk and a 28% decrease in disease progression, with 33% of patients alive after two years compared to 22% in chemotherapy alone. The treatment shows potential for addressing unmet needs in a challenging patient population. Regulatory applications are pending in Europe and Japan, reflecting AstraZeneca's commitment to cancer treatment advancements.