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AstraZeneca PLC (AZN) is a global biopharmaceutical leader focused on oncology, cardiovascular, respiratory, and immunology research. This centralized hub provides verified company announcements, press releases, and market-moving developments from authoritative sources.
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The latest results from the five-year follow-up of the PAOLA-1 and SOLO-1 Phase III trials for LYNPARZA (olaparib) indicate significant survival benefits for patients with advanced ovarian cancer. In the PAOLA-1 trial, 65.5% of HRD-positive patients survived five years with LYNPARZA plus bevacizumab, compared to 48.4% with bevacizumab alone. The SOLO-1 trial revealed 67% survival at seven years for patients with BRCA mutations using LYNPARZA versus 47% on placebo. These findings support LYNPARZA's effectiveness and call for increased biomarker testing.
AstraZeneca's IMFINZI (durvalumab) has received FDA approval for treating adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy. The approval follows the TOPAZ-1 Phase III trial results, demonstrating a 20% reduced risk of death compared to chemotherapy alone (HR 0.80). Notably, 25% of patients on IMFINZI plus chemotherapy were alive after two years, compared to 10% with chemotherapy alone. IMFINZI is now a first-line treatment option for BTC, with further regulatory reviews ongoing globally.
New pooled analysis results from the Phase III DAPA-HF and DELIVER trials show FARXIGA (dapagliflozin) reduced cardiovascular death risk by 14% and any cause death by 10% in heart failure patients, regardless of ejection fraction. These findings, presented at the European Society of Cardiology annual meeting and published in Nature Medicine, highlight FARXIGA as the first heart failure medication demonstrating mortality benefits across all ejection fractions. The analysis included over 11,000 participants from 20 countries.
AstraZeneca announced significant findings from the DELIVER Phase III trial for FARXIGA (dapagliflozin) at the European Society of Cardiology Congress 2022. The data show FARXIGA reduced cardiovascular death or worsening heart failure by 18% among patients with mildly reduced or preserved ejection fraction over a median follow-up of 2.3 years. These results support the expanded use of SGLT2 inhibitors in heart failure treatment, enhancing foundations for clinical guidelines. The safety profile remains consistent with previous studies.
AstraZeneca will showcase new cancer treatment data at ESMO Congress 2022, demonstrating efficacy and safety with 15 medicines across various cancers. Key highlights include long-term survival benefits for LYNPARZA in ovarian cancer and promising results from IMFINZI in liver and lung cancers. New findings on ENHERTU reinforce its potential in HER2-targetable cancers, while data from MEDI5752 will advance next-gen immunotherapy. The company aims to redefine cancer care by improving patient survival in areas of high unmet medical need.
AstraZeneca announced that the FDA has granted Priority Review for its supplemental New Drug Application (sNDA) for LYNPARZA (olaparib) in combination with abiraterone and prednisone for treating metastatic castration-resistant prostate cancer (mCRPC). This is significant as it could be the first combination therapy of a PARP inhibitor with a new hormonal agent, addressing a critical unmet need. The FDA's action date is expected in Q4 2022. The PROpel Phase III trial showed that the combination reduced disease progression risk by 34% compared to standard care.
Daiichi Sankyo and AstraZeneca announced positive topline results from the DESTINY-Breast02 phase 3 trial of ENHERTU, demonstrating significant improvement in progression-free survival in patients with HER2 positive metastatic breast cancer previously treated with T-DM1. The trial met both primary and key secondary endpoints, showing improved overall survival. Safety profiles remained consistent with earlier trials, with no new safety concerns. The trial results contribute to regulatory discussions for ENHERTU's current breast cancer indication.
AstraZeneca and Daiichi Sankyo's ENHERTU® has received FDA approval for treating unresectable or metastatic non-small cell lung cancer (NSCLC) with HER2 mutations in adults previously treated with systemic therapy. The accelerated approval is based on the DESTINY-Lung02 trial, which reported a confirmed objective response rate of 57.7% (n=52) and a median duration of response of 8.7 months. A milestone payment of $125 million is due from AstraZeneca to Daiichi Sankyo following this approval. ENHERTU is also approved for other HER2-positive cancers, reflecting its broad application potential.
Daiichi Sankyo and AstraZeneca’s ENHERTU has gained U.S. FDA approval for treating unresectable or metastatic non-small cell lung cancer (NSCLC) in patients with HER2 mutations after prior therapy. The decision is based on the DESTINY-Lung02 trial, showing a confirmed objective response rate of 57.7%. This approval marks the third tumor type for ENHERTU, emphasizing its significance. The FDA also approved diagnostic tests for HER2 mutations, enhancing treatment access. AstraZeneca will pay Daiichi Sankyo $125 million as a milestone payment related to this approval.
