Astrazeneca Plc - AZN STOCK NEWS

Daiichi Sankyo and AstraZeneca have initiated three global Phase 3 trials evaluating datopotamab deruxtecan (Dato-DXd) combinations in advanced nonsquamous non-small cell lung cancer (NSCLC). The trials include: TROPION-Lung10 testing Dato-DXd plus rilvegostomig in high PD-L1 expression patients; TROPION-Lung14 evaluating Dato-DXd plus osimertinib in EGFR mutated NSCLC; and TROPION-Lung15 studying Dato-DXd with/without osimertinib in EGFR mutated NSCLC that progressed on osimertinib. These trials are part of the expanding TROPION program, which now includes seven Phase 3 trials.

AstraZeneca's AIRSUPRA® (albuterol/budesonide) demonstrated statistically significant and clinically meaningful reduction in the risk of severe exacerbations in patients with intermittent or mild persistent asthma in the BATURA Phase III trial. The trial was stopped early due to overwhelming efficacy at a pre-planned analysis.

Key points:

• AIRSUPRA met the primary endpoint when used as an as-needed rescue medication compared to as-needed albuterol
• The trial included patients on short-acting beta2-agonist (SABA) alone, low-dose inhaled corticosteroid (ICS) maintenance therapy, or leukotriene receptor antagonist (LTRA) maintenance therapy
• Asthma affects 262 million people worldwide, including over 25 million in the US
• AIRSUPRA is the first anti-inflammatory rescue medication approved in the US for as-needed treatment of asthma in adults 18 years and older
• Safety and tolerability were consistent with AIRSUPRA's established profile

AstraZeneca's supplemental New Drug Application (sNDA) for CALQUENCE® (acalabrutinib) has been granted Priority Review by the FDA for treating previously untreated mantle cell lymphoma (MCL) in adults. This is based on the ECHO Phase III trial, which showed CALQUENCE combination reduced the risk of disease progression or death by 27% compared to standard chemoimmunotherapy.

Key points:

• FDA decision expected in Q1 2025
• MCL is a rare, aggressive form of non-Hodgkin lymphoma
• CALQUENCE plus bendamustine and rituximab provided almost 1.5 years additional median progression-free survival
• Safety profile consistent with known data
• Application being reviewed under Project Orbis for potential international approval

Arcus Biosciences (NYSE:RCUS) has announced a clinical trial collaboration agreement with AstraZeneca to evaluate casdatifan (AB521), Arcus's investigational HIF-2a inhibitor, in combination with volrustomig, AstraZeneca's investigational PD-1/CTLA-4 bispecific antibody, in patients with clear cell renal cell carcinoma (ccRCC). This marks the second clinical collaboration between the two companies.

The study, sponsored and operationalized by AstraZeneca, aims to assess the safety and early efficacy of the combination therapy in advanced ccRCC patients. Arcus believes casdatifan has best-in-class potential based on observed PK and PD profiles and emerging clinical data from their ARC-20 study. The collaboration seeks to improve outcomes for ccRCC patients by combining HIF-2a inhibition with volrustomig.

Under the Gilead and Arcus collaboration agreement, Gilead retains the right to opt-in to development and commercialization for casdatifan after Arcus delivers a qualifying data package.

AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for ENHERTU has been granted Priority Review in the US for treating HER2-low or HER2-ultralow metastatic breast cancer patients who have received at least one endocrine therapy. This is based on positive results from the DESTINY-Breast06 Phase III trial. The FDA action date is anticipated during Q1 2025.

ENHERTU also received Breakthrough Therapy Designation in this setting. The trial showed ENHERTU reduced the risk of disease progression or death by 37% compared to chemotherapy, with a median PFS of 13.2 months vs 8.1 months. Results were consistent in both HER2-low and HER2-ultralow expression patients.

If approved, ENHERTU would be the first HER2-directed therapy and antibody-drug conjugate for this patient population prior to chemotherapy for metastatic breast cancer.

ENHERTU, a HER2-directed antibody drug conjugate by Daiichi Sankyo and AstraZeneca, has been granted Priority Review in the U.S. for treating HER2 low or ultralow metastatic breast cancer patients who've received at least one endocrine therapy. This is based on the DESTINY-Breast06 phase 3 trial, which showed significant progression-free survival benefits. The FDA's decision date is set for February 1, 2025.

Key findings include:

• 37% reduced risk of disease progression or death
• 13.2 months median progression-free survival with ENHERTU vs 8.1 months with chemotherapy
• Consistent results in both HER2 low and ultralow expressions

If approved, ENHERTU would be the first HER2-directed therapy and antibody drug conjugate for these patients before chemotherapy in metastatic breast cancer treatment.

AstraZeneca's TAGRISSO® (osimertinib) has been approved in the US for treating adult patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) whose disease has not progressed during or following platinum-based chemoradiation therapy. The approval is based on the LAURA Phase III trial results, which showed TAGRISSO reduced the risk of disease progression or death by 84% compared to placebo. Median progression-free survival was 39.1 months for TAGRISSO versus 5.6 months for placebo. The safety profile was consistent with previous findings. TAGRISSO is now approved for patients with EGFR mutations across all stages of NSCLC. The approval addresses a critical need for targeted therapy in this patient population.

Datopotamab deruxtecan (Dato-DXd), a TROP2 directed antibody drug conjugate developed by Daiichi Sankyo and AstraZeneca, did not achieve statistical significance in final overall survival (OS) analysis in the TROPION-Breast01 phase 3 trial for patients with inoperable or metastatic HR positive, HER2 low or negative breast cancer. This follows previously reported positive progression-free survival (PFS) results.

Key points:

• The trial met its dual primary endpoint of PFS earlier
• Safety profile remained consistent with previous analysis
• Low rates of interstitial lung disease (ILD) were observed
• Subsequent treatments may have affected survival results

Despite the OS results, researchers noted the clinical value of datopotamab deruxtecan in this setting. The data will be presented at an upcoming medical meeting and shared with regulatory authorities.

FLUMIST, the only needle-free nasal spray flu vaccine in the US, has been approved for self-administration by adults up to 49 years old or caregiver administration for individuals 2-17 years old. This FDA approval, based on a usability study, makes FLUMIST the first self-administered influenza vaccine, allowing for at-home use.

The approval aims to increase vaccine accessibility and potentially boost vaccination rates, which have declined by 3.3% in US adults since 2020-21. FLUMIST Home will enable direct-to-home delivery for adults 18 and older through an online pharmacy system. The vaccine will also remain available in healthcare settings.

Seasonal influenza causes up to 1 billion infections annually, with 3-5 million severe cases. It impacts school attendance and work productivity, with 47% of school days and 1-2 workdays missed annually due to flu.