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.
Daiichi Sankyo and AstraZeneca’s ENHERTU has received FDA approval for earlier use in treating HER2 positive metastatic breast cancer. The approval follows the DESTINY-Breast03 trial, proving ENHERTU reduces disease progression or death risk by 72% compared to T-DM1. With a median progression-free survival not reached for ENHERTU versus 6.8 months for T-DM1, this milestone expands treatment options for patients. Additionally, a milestone payment of $100 million is due from AstraZeneca to Daiichi Sankyo following this approval.
AstraZeneca's supplemental Biologics License Application for Imfinzi (durvalumab) has been accepted for Priority Review in the US for treating locally advanced or metastatic biliary tract cancer (BTC). The FDA's decision is anticipated in Q3 2022. The application is based on the TOPAZ-1 Phase III trial, which revealed that Imfinzi combined with chemotherapy reduced death risk by 20% compared to chemotherapy alone. This new immunotherapy approach aims to improve treatment outcomes for BTC patients, who currently face poor prognoses.
Innate Pharma announced the first patient dosing in the Phase 3 PACIFIC-9 trial for patients with unresectable Stage III non-small cell lung cancer (NSCLC). This trial evaluates the efficacy of durvalumab in combination with monalizumab or oleclumab. The initiation of the trial triggers a $50 million milestone payment from AstraZeneca to Innate, strengthening its cash position. The PACIFIC-9 study aims to assess whether these combinations improve treatment outcomes following standard platinum-based concurrent chemoradiation therapy.
ULTOMIRIS (ravulizumab-cwvz) has received FDA approval for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-AChR antibody positive, representing 80% of gMG cases. This approval, stemming from the CHAMPION-MG Phase III trial, showed significant improvement in daily living activities. ULTOMIRIS is the first long-acting C5 complement inhibitor approved for gMG, enabling dosing every eight weeks. The trial involved 175 patients and presented a favorable safety profile, aligning with prior studies in similar conditions.
AstraZeneca and Daiichi Sankyo's ENHERTU received Breakthrough Therapy Designation in the US for treating HER2-low metastatic breast cancer. This designation is based on positive results from the DESTINY-Breast04 trial, which showed significant improvements in progression-free and overall survival compared to chemotherapy. ENHERTU, which has now secured five BTDs, aims to address the unmet need in breast cancer treatment, especially for patients with lower HER2 expression. The FDA’s expedited review process highlights the potential benefits for patients in urgent need of new therapies.
Daiichi Sankyo and AstraZeneca's ENHERTU has received its fifth Breakthrough Therapy Designation (BTD) from the FDA for treating adult patients with unresectable or metastatic HER2 low breast cancer. This designation follows positive results from the DESTINY-Breast04 trial, which demonstrated significant improvements in progression-free survival and overall survival compared to standard chemotherapy. The safety profile of ENHERTU remains consistent with previous trials. This designates ENHERTU as a potential game-changer for patients with lower HER2 expression, addressing a critical unmet medical need.
AstraZeneca announced that the FDA has accepted its Biologics License Application for a single priming dose of tremelimumab combined with Imfinzi for treating unresectable hepatocellular carcinoma (HCC). This STRIDE regimen aims to improve overall survival, supported by the Phase III HIMALAYA trial results showing a 22% reduction in death risk compared to sorafenib. The FDA decision is expected in Q4 2022. HCC is a major global health concern, with about 26,000 new advanced cases annually in the US. AstraZeneca continues to explore additional cancer treatment strategies.
AstraZeneca's EVUSHELD (tixagevimab and cilgavimab) has shown a significant reduction in symptomatic COVID-19 risk by 77% in the primary analysis and 83% in follow-ups, according to the PROVENT Phase III trial. No severe cases or COVID-19 related deaths occurred in the EVUSHELD group over six months. More than 75% of trial participants had high-risk comorbidities. The drug demonstrated long-term efficacy with elevated serum concentrations lasting six months. EVUSHELD is authorized for emergency use, particularly benefiting immunocompromised individuals unable to adequately respond to vaccination.
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.