Astrazeneca Plc Stock Price, News & Analysis

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.

Updated results from the TNBC cohort of the TROPION-PanTumor01 phase 1 trial of datopotamab deruxtecan by Daiichi Sankyo and AstraZeneca showed a 34% objective response rate (ORR) in 44 patients with metastatic triple negative breast cancer (TNBC). In a subgroup of 27 untreated patients, the ORR was 52%. The disease control rate (DCR) was 77% overall, with no new safety signals reported. AstraZeneca plans to initiate a registrational phase 3 study based on these encouraging outcomes, addressing a critical need in TNBC treatment.

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.