Astrazeneca Plc - AZN STOCK NEWS

Datopotamab deruxtecan (Dato-DXd) has received Breakthrough Therapy Designation (BTD) from the FDA for treating adult patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) who have experienced disease progression after EGFR tyrosine kinase inhibitor and platinum-based chemotherapy treatments.

The BTD, which aims to accelerate development and regulatory review of promising medicines, was granted based on data from the TROPION-Lung05 phase 2 trial and supporting data from the TROPION-Lung01 phase 3 trial. This marks the first BTD for datopotamab deruxtecan and the twelfth BTD across Daiichi Sankyo's oncology pipeline.

Daiichi Sankyo and AstraZeneca have submitted a new Biologics License Application for accelerated approval in the U.S. for this treatment.

AstraZeneca's CALQUENCE demonstrated significant results in the AMPLIFY Phase III trial for previously untreated chronic lymphocytic leukemia (CLL). When combined with venetoclax, it reduced disease progression or death risk by 35% compared to standard chemoimmunotherapy. Adding obinutuzumab further improved results, showing a 58% risk reduction.

At 36 months, progression-free survival rates were 76.5% for CALQUENCE plus venetoclax and 83.1% with obinutuzumab addition, versus 66.5% for standard care. Overall response rates exceeded 92% in both CALQUENCE arms compared to 75.2% for standard treatment. The safety profile was consistent with known data, with no new safety signals identified.

AstraZeneca's IMFINZI® (durvalumab) has received Priority Review from the FDA for treating muscle-invasive bladder cancer (MIBC). The decision is based on the NIAGARA Phase III trial results, which showed significant improvements in event-free and overall survival. The trial demonstrated a 32% reduction in disease progression risk and a 25% reduction in death risk with IMFINZI compared to standard treatment.

The treatment involves IMFINZI combined with neoadjuvant chemotherapy before radical cystectomy, followed by IMFINZI monotherapy. At two years, 67.8% of IMFINZI-treated patients were event-free compared to 59.8% in the control group, and 82.2% were alive versus 75.2% in the control group. If approved, this would be the first perioperative immunotherapy regimen in this setting.

Datopotamab deruxtecan demonstrated significant clinical activity in a pooled analysis of TROPION-Lung05 and TROPION-Lung01 trials for previously treated EGFR-mutated non-small cell lung cancer (NSCLC) patients. The analysis showed a 42.7% objective response rate in 117 patients, with a median duration of response of 7.0 months and disease control rate of 86.3%.

The drug showed similar efficacy in patients previously treated with osimertinib, achieving a 44.8% objective response rate in 96 patients. The safety profile remained consistent with previous reports, with stomatitis, alopecia, and nausea being the most common treatment-related adverse events.

AstraZeneca's IMFINZI has received FDA approval as the first and only immunotherapy for -stage small cell lung cancer (LS-SCLC) patients whose disease hasn't progressed following concurrent platinum-based chemotherapy and radiation therapy. The approval is based on the ADRIATIC Phase III trial results, which demonstrated:

- 27% reduction in death risk versus placebo
- Median overall survival of 55.9 months vs 33.4 months for placebo
- 57% of IMFINZI-treated patients survived at three years vs 48% for placebo
- 24% reduction in disease progression or death risk
- Median progression-free survival of 16.6 months vs 9.2 months for placebo

The safety profile was manageable and consistent with known effects, with no new safety signals observed.

TRUQAP (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) has shown significant improvement in radiographic progression-free survival for patients with PTEN-deficient metastatic hormone-sensitive prostate cancer in the CAPItello-281 Phase III trial. The study demonstrated an early trend towards overall survival improvement, though data were immature at analysis time. This marks TRUQAP as the first and only AKT inhibitor combination showing benefit in this specific prostate cancer subtype. The trial targets a critical patient population, as approximately 25% of the 200,000 annual mHSPC diagnoses have PTEN-deficient tumors, which typically indicate poor prognosis.

AstraZeneca has pledged $3.5 million to nonprofit organizations across the US through its Accelerate Change Together (ACT) on Health Equity initiative, bringing total contributions to over $15 million. The program will fund 53 nonprofit programs, including 45 local organizations receiving $30,000 each and eight national nonprofits sharing $2.15 million. The initiatives focus on improving healthcare access, addressing social determinants of health, advancing chronic disease care, and expanding STEM education in underserved communities. The funding supports programs targeting asthma, cardiovascular disease, COPD, heart failure, lupus, and oncology.

GRAIL announced the first patient testing in the global TROPION-Lung12 Phase 3 study using their Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay. The study, conducted under FDA approval, evaluates adjuvant treatments in Stage I adenocarcinoma NSCLC patients. The trial is sponsored by AstraZeneca in collaboration with Daiichi Sankyo.

GRAIL's blood-based methylation platform detects ctDNA without requiring tissue analysis, streamlining integration into clinical trials. Patients will be screened pre-surgery to determine eligibility for post-surgery treatment. This marks one of the first uses of ctDNA assay in early-stage lung cancer trials to identify patients who may benefit from additional treatment.

AstraZeneca announces a $3.5 billion capital investment in the United States to expand its research and manufacturing footprint by 2026. The investment includes $2 billion of new funding that will create over 1,000 high-skilled jobs. The expansion encompasses a new R&D centre in Cambridge, Massachusetts, biologics manufacturing in Maryland, cell therapy facilities on both coasts, and specialty manufacturing in Texas. This investment is part of AstraZeneca's strategy to achieve $80 billion in Total Revenue by 2030. The US currently represents 44% of AstraZeneca's Total Revenue, making it the company's largest market with 17,800 employees across 17 sites in 12 states.