AstraZeneca PLC develops and commercializes prescription medicines across oncology, rare diseases, and BioPharmaceuticals, including cardiovascular, renal and metabolism, respiratory, and immunology. News about AZN commonly covers clinical-trial results, FDA and advisory-committee actions, product approvals, and updates to marketed medicines such as TRUQAP, BREZTRI, SAPHNELO, IMFINZI, IMJUDO, and ULTOMIRIS.
Company updates also address quarterly revenue and earnings trends, alliance and collaboration revenue, licensing transactions for pipeline assets, and governance changes. Recurring development themes include targeted oncology, COPD, asthma, systemic lupus erythematosus, liver cancer, prostate cancer, and rare or immune-mediated diseases.
The FDA has granted ENHERTU Breakthrough Therapy Designation for treating adult patients with unresectable or metastatic HER2-positive breast cancer. This designation is based on the DESTINY-Breast03 trial, showing a 72% reduction in disease progression or death compared to T-DM1. ENHERTU now holds four BTDs, with the total patient survival rate at one year reaching 94.1%. The designation aims to expedite development for medicines addressing significant unmet medical needs. The ongoing comprehensive clinical program assesses ENHERTU across various HER2-targetable cancers.
Compugen Ltd. (NASDAQ: CGEN) announced a $6 million milestone payment from AstraZeneca (NASDAQ: AZN) following the first patient dosing in a Phase 1/2 study of AZD2936, a TIGIT/PD-1 bispecific antibody for lung cancer. This event marks the advancement of Compugen's COM902 program into clinical trials, contributing to its pipeline expansion. To date, Compugen has received a total of $12 million from AstraZeneca under their 2018 license agreement, which could potentially yield up to $200 million in milestone payments and royalties on sales.
On World Heart Day, the AstraZeneca HealthCare Foundation awarded $954,311 in grants to seven nonprofit organizations across the US to combat cardiovascular disease. This initiative is part of the Connections for Cardiovascular Health program aiming to enhance heart health among underserved communities. Since 2010, the Foundation has allocated over $25 million to various projects, impacting over 1.7 million individuals. The grant recipients include organizations addressing health screening, nutrition education, and access to healthcare services.
AstraZeneca will present data on its COVID-19 and RSV pipeline at the IDWeek 2021 conference, showcasing the long-acting antibody AZD7442 and its potential for COVID-19 prevention. Phase III PROVENT trial results indicate AZD7442 may reduce symptomatic COVID-19 risk significantly, particularly in vulnerable populations. The analysis will also cover the efficacy of AZD1222 in preventing asymptomatic infections and the recently developed nirsevimab for RSV protection in infants. Preliminary findings suggest that AZD7442 neutralizes emerging SARS-CoV-2 variants and regulatory submissions for emergency use authorization are forthcoming.
AstraZeneca and Merck have announced promising results from the PROpel Phase III trial of LYNPARZA® (olaparib) combined with abiraterone in treating men with metastatic castration-resistant prostate cancer (mCRPC). The trial demonstrated statistically significant improvement in radiographic progression-free survival (rPFS) compared to standard treatment. Although there was a trend towards better overall survival, further assessment is needed. The findings offer hope for new treatment options for patients with limited choices.
AstraZeneca's IMFINZI (durvalumab) has demonstrated significant progress in treating extensive-stage small cell lung cancer (ES-SCLC) according to updated results from the CASPIAN Phase III trial. The treatment, in combination with etoposide and either carboplatin or cisplatin, provides a 29% reduction in the risk of death compared to chemotherapy alone, with a median overall survival increased to 12.9 months. At three years, 17.6% of patients were alive on IMFINZI, compared to 5.8% with chemotherapy alone. The treatment remains well-tolerated with safety profiles consistent with established medications.
Results from the DESTINY-Breast03 Phase III trial indicate that ENHERTU significantly outperformed T-DM1 in treating previously treated HER2-positive breast cancer, offering a 72% reduction in progression risk (HR 0.28). With a median progression-free survival (PFS) not yet reached for ENHERTU versus 6.8 months for T-DM1 and a confirmed objective response rate (ORR) of 79.7%, the drug showcases promising efficacy. Safety data revealed manageable adverse events with no Grade 4 or 5 interstitial lung disease cases. These findings support ENHERTU's potential as a new standard of care.
ENHERTU (fam-trastuzumab deruxtecan-nxki) has shown a significant tumor response in previously treated patients with HER2-mutant unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC), as demonstrated in the Phase II DESTINY-Lung01 trial. The results revealed a confirmed objective response rate (ORR) of 54.9% and a disease control rate (DCR) of 92.3%. The median overall survival was 17.8 months, highlighting ENHERTU’s potential as a new standard of care for this patient population. The overall safety profile aligns with prior studies, with manageable adverse events.
The DESTINY-Gastric02 Phase II trial results for ENHERTU®, a HER2-directed antibody drug conjugate developed by AstraZeneca and Daiichi Sankyo, indicate a 38% confirmed overall response rate (ORR) in patients with HER2-positive metastatic gastric cancer after previous trastuzumab treatment. With a median duration of response of 8.1 months and a progression-free survival of 5.5 months, these findings align with prior DESTINY-Gastric01 results, supporting ENHERTU's potential in this challenging patient population. The safety profile remains consistent, highlighting the ongoing need for effective treatment options for advanced gastric cancer.
Results from the COAST Phase II trial show that combining oleclumab or monalizumab with IMFINZI significantly delays disease progression and enhances response rates in patients with unresectable Stage III NSCLC post-chemoradiation. The trial revealed a 56% reduced progression risk with oleclumab and 35% with monalizumab, alongside increased progression-free survival rates. Additionally, PACIFIC-R data suggests long-term efficacy for IMFINZI in a real-world context, with a median progression-free survival of 21.7 months. AstraZeneca plans to initiate registrational trials based on these promising findings.