Astrazeneca Plc Stock Price, News & Analysis

Daiichi Sankyo announced that the European Medicines Agency (EMA) has validated the Type II Variation Application for trastuzumab deruxtecan, a HER2 directed antibody drug conjugate developed with AstraZeneca (AZN). This application aims to treat adult patients with advanced or metastatic HER2 positive gastric cancer, following a prior anti-HER2 regimen. The validation signals the start of a scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

New analyses from the TULIP Phase III clinical trials demonstrate that SAPHNELO (anifrolumab), a type I interferon antagonist, significantly reduces systemic lupus erythematosus (SLE) disease activity compared to standard therapy alone. Presented at ACR Convergence 2021, the data indicate consistent efficacy regardless of disease duration or prior treatments. Notably, SAPHNELO showed a 14.4% improvement over standard therapy in recently diagnosed patients, and 17.1% in those with established disease, along with better response rates across various baseline therapies.

AstraZeneca has launched the ACT on Health Equity: Community Solutions Challenge, contributing funds to 30 nonprofit organizations across the US. This initiative aims to enhance health equity by supporting underserved populations. Over 1,350 applications were received in its inaugural year, reflecting a wide interest in community health and youth education. The challenge aligns with AstraZeneca's long-term commitment to health equity and is supported by experts in the field. Programs funded will employ community-based approaches to improve local health outcomes.

Positive Results from TOPAZ-1 Trial: IMFINZI combined with chemotherapy shows significant overall survival benefits for advanced biliary tract cancer (BTC) patients compared to chemotherapy alone.

The Independent Data Monitoring Committee confirmed the trial met its primary endpoint, demonstrating improved progression-free survival and overall response rate. IMFINZI's safety profile aligns with standard chemotherapy, with no increase in adverse event discontinuation rates.

With about 210,000 BTC cases annually worldwide, these findings mark a pivotal advancement for a cancer with limited treatment options.

Daiichi Sankyo and AstraZeneca have entered into a collaboration with Merck to advance the TROPION-Lung08 phase 3 trial. This trial will evaluate the TROP2 directed ADC, datopotamab deruxtecan, in combination with Merck's KEYTRUDA in treatment-naïve patients with PD-L1 high advanced or metastatic non-small cell lung cancer (NSCLC). The trial aims to improve outcomes compared to KEYTRUDA alone, addressing the significant patient population that does not respond to current therapies. Approximately 740 patients are expected to be enrolled across multiple regions.

AstraZeneca, alongside Scientific American Custom Media, announced the winners of the 2021 Cancer Community Awards (C2 Awards). This year, a new Catalyst for Equity Award was introduced to support health equity for disadvantaged communities. Over 100 nominations were received from 28 states. Winners received a $50,000 donation for a nonprofit organization. The awards recognize individuals and organizations making significant contributions in oncology, aiming to enhance cancer care and ensure equitable access to treatments.

Positive results from the HIMALAYA Phase III trial indicated that a single dose of tremelimumab alongside IMFINZI yielded significant overall survival benefits compared to sorafenib for patients with unresectable hepatocellular carcinoma (HCC). The combination therapy, named the STRIDE regimen, also showcased a favorable safety profile, with no increase in severe hepatic toxicity. IMFINZI alone showed non-inferior overall survival against sorafenib, trending favorably with improved tolerability. The study involved 1,324 patients across 190 centers worldwide.

AstraZeneca has received Orphan Drug Designation from the FDA for Tezepelumab to treat eosinophilic esophagitis (EoE), a rare inflammatory disease affecting the esophagus. This designation is crucial as it supports the development of therapies for diseases impacting fewer than 200,000 patients in the U.S. Currently, no FDA-approved treatments exist for EoE. Tezepelumab is also under Priority Review for asthma in the U.S., with decisions anticipated in early 2022. The collaboration between AstraZeneca and Amgen continues, enabling joint commercialization efforts.

AstraZeneca has filed for Emergency Use Authorization (EUA) with the US FDA for AZD7442, a long-acting antibody combination to prevent symptomatic COVID-19. The drug shows a 77% reduction in risk based on data from the PROVENT Phase III trial. This submission marks a significant step as AZD7442 could be the first long-acting antibody approved for COVID-19 prevention. The trial included participants with comorbidities, with over 75% at increased risk. AZD7442 leverages proprietary technology to enhance its durability, potentially offering up to 12 months of protection.