AstraZeneca

I-DXd (ifinatamab deruxtecan) showed clinically meaningful responses in pretreated extensive-stage SCLC patients, with a confirmed response rate of 26.1% at 8 mg/kg and 54.8% at 12 mg/kg. The 12 mg/kg dose was selected as optimal for further study.

Adding novel agents to perioperative durvalumab for NSCLC led to higher pCR and mPR rates compared to historical rates with durvalumab and chemotherapy. The highest response rates occurred with the addition of Dato-DXd (pCR 34.1%, mPR 65.9%). All combinations demonstrated manageable safety profiles and surgical rates comparable to approved regimens.

Bank of America Securities' Sachin Jain maintains Buy rating on AstraZeneca (AZN) with a £14,500.00 price target, citing positive biomarker data from datopotamab TL01 study in second-line lung cancer and potential catalysts like AVANZAR phase III trial in 2025.

AstraZeneca completed its clinical program for a new inhaler propellant with 99.9% lower Global Warming Potential (GWP), marking a significant step in reducing the environmental impact of respiratory medicines. This propellant, HFO-1234ze, will be used in Breztri/Trixeo Aerosphere, a COPD therapy, with regulatory filings planned for Europe, the UK, and China by end of 2024. This aligns with AstraZeneca's Ambition Zero Carbon strategy to cut its carbon footprint by 50% by 2030.

GSK’s long-acting asthma treatment, depemokimab, reduced serious attacks by 54% and hospitalizations/ER visits by 72% in Phase III trials. Despite missing secondary endpoints, the drug’s primary goal of reducing exacerbations was achieved. Depemokimab, an anti-IL-5 therapy, is part of GSK’s planned 12 major product launches, expected to generate £38 billion by 2031, with peak sales of £3 billion. Administered twice yearly, it aims to address unmet needs in severe asthma treatment.

AstraZeneca and Daiichi Sankyo unveiled an AI-powered TROP2-QCS biomarker predicting clinical outcomes in NSCLC patients treated with datopotamab deruxtecan. In TROPION-Lung01 Phase III study, TROP2-QCS-positive patients showed a 43% reduction in disease progression or death risk with Dato-DXd vs. docetaxel, compared to 25% in the overall study population. TROP2-QCS, developed via AstraZeneca’s QCS platform, assesses TROP2 membrane expression relative to cytoplasm, classifying patients as TROP2-QCS-positive if 75% of tumor cells have an NMR below a specified value.

The early development of GLP-1 drugs, led by Jeffrey Flier and colleagues, faced abandonment by Pfizer in 1991 due to misconceptions about their potential. Despite promising results, Pfizer's decision to focus on non-injection delivery methods led to the termination of the project. The GLP-1 class eventually achieved significant commercial success, highlighting the complexities and uncertainties in drug development.

AstraZeneca completed clinical studies for a new inhaler propellant, HFO-1234ze, reducing greenhouse gas emissions by 99.9%. Breztri, a COPD therapy, will be the first to transition, with regulatory submissions expected in Europe, the UK, and China by end of 2024. This aligns with AstraZeneca's Ambition Zero Carbon strategy.

TROPION-Lung01 Phase III trial results show datopotamab deruxtecan (6.0mg/kg) had a median OS of 12.9 months vs. 11.8 months for docetaxel (75mg/m²) in advanced NSCLC patients. The HR was 0.94 (95% CI 0.78-1.14), with a p-value of 0.530. In nonsquamous histology, datopotamab deruxtecan showed a median OS of 14.6 months vs. 12.3 months for docetaxel, with an HR of 0.84 (95% CI 0.68-1.05). Patients with actionable genomic alterations saw a median OS of 15.6 months with datopotamab deruxtecan vs. 9.8 months with docetaxel, HR 0.65 (95% CI 0.40-1.08). NeoCOAST-2 trial showed datopotamab deruxtecan plus Imfinzi and carboplatin had a pCR rate of 34.1% and mPR rate of 65.9% in early-stage resectable NSCLC.

Benralizumab (Fasenra) is a monoclonal antibody for severe asthma with an eosinophilic phenotype, under development for various conditions including COPD and HES. AstraZeneca, its developer, focuses on respiratory, cardiovascular, and metabolic diseases, among others, and operates globally.