AstraZeneca PLC - AZN STOCK NEWS

Daiichi Sankyo announces the initiation of the DESTINY-Lung04 phase 3 trial, dosing its first patient to evaluate ENHERTU® (trastuzumab deruxtecan) for treating HER2 mutant unresectable, locally advanced, or metastatic non-squamous non-small cell lung cancer (NSCLC).

This head-to-head trial compares ENHERTU to standard care (platinum-pemetrexed doublet chemotherapy with pembrolizumab), targeting a patient group with limited current treatment options. Lung cancer remains a top cancer mortality cause, with HER2 mutations observed in 2% to 4% of NSCLC cases.

AstraZeneca's EVUSHELD, a long-acting antibody therapy for COVID-19 prevention, shows retained neutralization efficacy against the Omicron variant, as reported by studies from University College Oxford and Washington University. With an IC50 of 273 ng/ml and 147 ng/ml, the data indicate promising neutralizing activity, ensuring its role in protecting vulnerable populations. EVUSHELD is the only antibody authorized in the US for pre-exposure prophylaxis against COVID-19, and its Emergency Use Authorization was granted in December 2021. Future publications will detail these findings further.

AstraZeneca's EVUSHELD, a long-acting antibody combination, has shown effectiveness against the Omicron variant of SARS-CoV-2 according to new preclinical data. The Inhibitory Concentration 50 (IC50) values were 171 ng/ml and 277 ng/ml, indicating significant neutralizing activity. EVUSHELD received Emergency Use Authorization (EUA) in December 2021 for pre-exposure prophylaxis in at-risk individuals. It demonstrated a 50% reduction in severe COVID-19 risk in non-hospitalized patients in the TACKLE Phase III trial. Further studies on its efficacy against Omicron are ongoing.

Transgene announced that AstraZeneca has exercised its first license option for an Invir.IO™ oncolytic virus, resulting in an upfront payment of $8 million. This collaboration, ongoing since 2019, allows AstraZeneca to choose transgenes for integration while Transgene contributes its expertise in viral design. The agreement includes potential development and sales milestones, as well as royalties on future commercial sales. Transgene's pilot manufacturing capability enables it to produce drug candidates for clinical development, enhancing its market prospects in oncological treatments.

Samsung Biologics and AstraZeneca have expanded their strategic collaboration, increasing the agreement's value to approximately $380 million from $331 million. The partnership focuses on manufacturing AstraZeneca's COVID-19 long-acting antibody combination, AZD7442, authorized for COVID-19 prevention. Additionally, starting next year, Samsung will produce a cancer immunotherapy product. This collaboration aims to enhance patient safety and expedite crucial therapies during the pandemic and beyond.

AstraZeneca presented updated results from the ASCEND Phase III trial at the ASH Annual Meeting, highlighting CALQUENCE's significant efficacy for relapsed chronic lymphocytic leukemia. After three years, CALQUENCE demonstrated a 71% lower risk of disease progression or death compared to investigator's choice therapies. Moreover, safety data from the ELEVATE-RR trial revealed CALQUENCE had fewer adverse events than ibrutinib, particularly in terms of atrial fibrillation incidence. CALQUENCE is approved for CLL and small lymphocytic lymphoma, with ongoing studies for its use in various hematologic malignancies.

New data from the DESTINY-Breast03 trial presented at SABCS 2021 show that AstraZeneca and Daiichi Sankyo’s ENHERTU demonstrated superior progression-free survival (PFS) and objective response rate (ORR) in HER2-positive breast cancer patients compared to T-DM1. In a subgroup with stable brain metastases, ENHERTU achieved a median PFS of 15 months versus 3 months for T-DM1. Overall, the confirmed ORR was 67.4% for ENHERTU against 20.5% for T-DM1. ENHERTU is gaining recognition for its potential to improve treatment options for patients with previously treated HER2-positive metastatic breast cancer.

The DESTINY-Breast03 phase 3 trial results presented at SABCS 2021 show that ENHERTU (trastuzumab deruxtecan) significantly outperforms T-DM1 in treating HER2 positive metastatic breast cancer. ENHERTU demonstrated higher progression-free survival (PFS) and objective response rate (ORR), particularly in patients with stable brain metastases. Notably, PFS for these patients was 15 months for ENHERTU compared to just 3 months for T-DM1. The safety profile remains consistent, with a low incidence of severe adverse events. These findings suggest ENHERTU's potential as a new standard of care.

AstraZeneca's EVUSHELD, a long-acting antibody combination, has received emergency use authorization (EUA) from the FDA for COVID-19 pre-exposure prophylaxis. Designed for patients aged 12 and older with moderate to severe immune compromise, it provides long-term protection. Data from the PROVENT Phase III trial indicated a significant reduction in symptomatic COVID-19 cases, showing 83% efficacy at six months post-administration. AstraZeneca plans to supply 700,000 doses to the US government, aiming for global filings for further authorization.