Astrazeneca Plc - AZN STOCK NEWS

AstraZeneca and Daiichi Sankyo have received acceptance for the supplemental Biologics License Application (sBLA) of ENHERTU for treating adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) harboring a HER2 mutation. The FDA has granted Priority Review status, indicating potential significant improvements over current treatments. Results from the DESTINY-Lung01 trial showed a 54.9% tumor response rate, with a disease control rate of 92.3%. Approval could provide a new targeted therapy for patients currently lacking options.

Daiichi Sankyo and AstraZeneca announced that their sBLA for ENHERTU, a HER2-targeted therapy for metastatic non-small cell lung cancer, has been accepted by the FDA for Priority Review. Based on the DESTINY-Lung01 trial, ENHERTU achieved a remarkable 54.9% tumor response rate and a confirmed disease control rate of 92.3%. The median overall survival was 17.8 months, promising for patients with HER2 mutations. This therapy marks a significant advancement, as currently, no HER2 directed therapies exist for this specific cancer type.

Blueprint Medicines announced promising early results from the Phase 1/2 SYMPHONY trial for BLU-945, aimed at treating advanced EGFR-mutant non-small cell lung cancer (NSCLC). The data indicate dose-dependent reductions in circulating tumor DNA and tumor burden, with BLU-945 showing good tolerability—mostly Grade 1 or 2 adverse events. A partnership with AstraZeneca has been established for osimertinib in combination studies. Plans to initiate new trial cohorts and expand development by year-end 2022 were also highlighted, showcasing the potential for BLU-945 as a combination therapy.

ULTOMIRIS (ravulizumab-cwvz) demonstrated long-term efficacy in adults with generalized myasthenia gravis (gMG) from the Phase III CHAMPION-MG trial. Key findings showed significant improvements in muscle strength and quality of life sustained through 60 weeks. Results presented at the American Academy of Neurology Annual Meeting on April 5 emphasized that 99.4% of participants transitioned to an open-label extension, showing rapid response after switching from placebo. ULTOMIRIS was well-tolerated, with common adverse events including headache (16.6%) and diarrhea (13.6%). Regulatory submissions are under review globally.

AstraZeneca, in collaboration with PGA Champion Jason Day, launched the Getting Out of the Rough campaign to raise awareness about the importance of biomarker testing for lung cancer diagnosis. The campaign features a six-episode video series that includes discussions with experts and celebrities, emphasizing how biomarker testing can guide treatment plans. Day's personal experience with his mother's lung cancer diagnosis highlights the need for comprehensive testing. The first episode premiered on April 4, 2022. For more information, visit www.diagnosisstories.com.

AstraZeneca has partnered with the National Fish and Wildlife Foundation to plant one million trees in the U.S. by 2025, part of its Ambition Zero Carbon program aiming for carbon negativity by 2030. This initiative will enhance water quality and wildlife habitats in the Delaware River Watershed while tackling climate change through improved carbon storage. Funding will support urban reforestation and various projects in Delaware, New Jersey, and Pennsylvania. A total of 15 grants will initiate the planting of over 118,000 trees in these regions.

AstraZeneca has announced that new in vivo data from Washington University shows that its COVID-19 treatment, EVUSHELD (tixagevimab combined with cilgavimab), effectively reduces the viral load of the Omicron variants BA.1, BA.1.1, and BA.2 in mice. The study indicates that EVUSHELD limited lung inflammation and viral burden, critical factors in severe COVID-19 outcomes. This reinforces its role as a prophylactic option for high-risk patients, particularly the immunocompromised. The findings were reported on bioRxiv, highlighting the treatment's ongoing relevance amidst emerging variants.

AstraZeneca and Merck announced positive results from the OlympiA Phase III trial, demonstrating that LYNPARZA® significantly improves overall survival in patients with germline BRCA-mutated high-risk HER2-negative early breast cancer. Compared to placebo, LYNPARZA reduced the risk of death by 32% (HR 0.68; p=0.009), with three-year survival rates of 92.8% versus 89.1%. This trial is pivotal as it marks the first overall survival benefit from a PARP inhibitor in early breast cancer. LYNPARZA is approved in multiple regions for this indication, reinforcing its role in targeted cancer therapy.

AstraZeneca and Merck announced that LYNPARZA (olaparib) is now approved in the US for adjuvant treatment of germline BRCA-mutated, HER2-negative high-risk early breast cancer patients. This decision follows results from the OlympiA Phase III trial, where LYNPARZA showed a 42% reduction in invasive disease recurrence and a 32% decrease in the risk of death versus placebo. AstraZeneca expects a $175 million milestone payment from Merck as a result of this approval.