Astrazeneca Plc - AZN STOCK NEWS

Updated results from the POSEIDON Phase III trial reveal that adding a limited course of tremelimumab to IMFINZI and chemotherapy significantly improves overall survival (OS) for patients with Stage IV non-small cell lung cancer (NSCLC). After nearly four years of follow-up, the combination therapy led to a 25% reduction in the risk of death (HR 0.75) and a median OS of 14 months compared to 11.7 months for chemotherapy alone. Notably, patients with specific mutations such as STK11 and KRAS showed even greater OS improvements. These findings were presented at the ESMO Congress 2022.

AstraZeneca's TAGRISSO (osimertinib) has shown significant efficacy in a Phase III trial (ADAURA) for patients with early-stage EGFR-mutated non-small cell lung cancer (NSCLC). Updated results indicate that nearly 75% of patients were alive and disease-free at four years, with TAGRISSO reducing the risk of disease recurrence by 77% and 76% for central nervous system (CNS) occurrences. The trial included 682 patients and demonstrated median disease-free survival of 65.8 months for TAGRISSO versus 21.9 months for placebo.

The DESTINY-Lung02 phase 2 trial results indicate that ENHERTU (trastuzumab deruxtecan) shows significant efficacy in treating HER2 mutant, unresectable, and metastatic non-small cell lung cancer (NSCLC). The 5.4 mg/kg dose demonstrated a confirmed objective response rate (ORR) of 53.8%, while the 6.4 mg/kg dose yielded an ORR of 42.9%. The safety profile was favorable, with higher grade 3 adverse events in the 6.4 mg/kg group. Updated results from DESTINY-Lung01 reaffirm ENHERTU's sustained efficacy, with a median overall survival of 18.6 months for patients with HER2 mutant NSCLC.

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.