Astrazeneca Plc Stock Price, News & Analysis

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.

AstraZeneca announced positive results from the POSEIDON Phase III trial, showing that the addition of tremelimumab to IMFINZI and chemotherapy significantly improved overall survival (OS) and progression-free survival (PFS) in Stage IV non-small cell lung cancer (NSCLC) patients. Patients receiving the combination demonstrated a 23% reduction in death risk and median OS of 14.0 months. The treatment was well-tolerated, with no increase in treatment discontinuation rates compared to chemotherapy alone. Regulatory discussions regarding these findings are anticipated.

Positive results from the Phase III MANDALA and DENALI trials for PT027, a fixed-dose inhaler combining albuterol and budesonide, were announced. PT027 significantly reduced the risk of severe asthma exacerbations compared to albuterol and improved lung function in patients with mild to moderate asthma. The MANDALA trial involved 3,132 patients, while DENALI included 1,001 participants. Both trials met their primary endpoints, indicating PT027's potential as a first-in-class treatment for asthma. AstraZeneca and Avillion are advancing this promising new therapy.

AstraZeneca announced that FLUMIST® QUADRIVALENT, the only FDA-approved nasal-spray flu vaccine, is now available in the US for the 2021-2022 influenza season. Indicated for ages 2 to 49, its supply is expected to bulk by mid-September. The CDC emphasizes flu vaccination as crucial to reduce healthcare burdens. FLUMIST is expected to be preferred by patients due to its needle-free delivery method. Common side effects include runny nose, sore throat, and fever. The vaccine is covered by most health plans.