Astrazeneca Plc - AZN STOCK NEWS

ENHERTU in combination with pertuzumab has shown highly significant improvement in progression-free survival (PFS) compared to current first-line standard treatment (taxane, trastuzumab and pertuzumab - THP) for HER2-positive metastatic breast cancer patients in the DESTINY-Breast09 Phase III trial.

This marks the first trial in over a decade demonstrating superior efficacy across broad HER2-positive metastatic breast cancer population versus current standard care. The PFS improvement was observed across all pre-specified patient subgroups. While overall survival data wasn't mature, early trends favor the ENHERTU combination.

HER2-positive metastatic breast cancer affects 15-20% of metastatic breast cancer patients. Despite current treatments, most patients experience disease progression within two years of first-line THP treatment, with approximately one-third never receiving second-line therapy due to progression or death.

AstraZeneca (AZN) and Daiichi Sankyo reported positive topline results from the DESTINY-Breast09 phase 3 trial, showing ENHERTU combined with pertuzumab significantly improved progression-free survival compared to current standard treatment in first-line HER2 positive metastatic breast cancer patients.

The trial demonstrated superior efficacy across all pre-specified patient subgroups. While overall survival data was not mature, early trends favor the ENHERTU combination. This marks the first trial in over a decade showing superior efficacy versus the current first-line standard of care for broad HER2 positive metastatic breast cancer patients.

HER2 positive metastatic breast cancer affects 15-20% of metastatic breast cancer patients, with most experiencing disease progression within two years of first-line treatment. The safety profile of ENHERTU with pertuzumab aligned with known profiles of each therapy. Regulatory submissions are now underway.

DATROWAY® (datopotamab deruxtecan) has received EU approval for treating adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have undergone endocrine therapy and at least one chemotherapy line in advanced settings. The approval is based on the TROPION-Breast01 phase 3 trial results.

Key findings show DATROWAY reduced disease progression or death risk by 37% compared to standard chemotherapy. The median progression-free survival was 6.9 months for DATROWAY versus 4.9 months with chemotherapy. The objective response rate was 36% for DATROWAY compared to 23% for chemotherapy, with a median duration of response of 6.7 months versus 5.7 months respectively.

Overall survival results were not statistically significant, with median OS of 18.6 months for DATROWAY versus 18.3 months for chemotherapy. The most common Grade 3 or higher adverse events included stomatitis (7.9%), fatigue (4.3%), and anemia (3.2%).

ENHERTU® has received EU approval as the first HER2-directed therapy for patients with HR positive, HER2 low or HER2 ultralow metastatic breast cancer who have received at least one endocrine therapy. The approval is based on the DESTINY-Breast06 phase 3 trial results, where ENHERTU showed:

- 38% reduction in disease progression or death risk vs chemotherapy
- Median progression-free survival of 13.2 months vs 8.1 months with chemotherapy
- Objective response rate of 56.5% vs 32.2% with chemotherapy

The approval expands ENHERTU's use to earlier treatment settings and broadens eligible patients to include HER2 ultralow disease. HR positive, HER2 negative represents approximately 70% of all breast cancers. Following this approval, AstraZeneca will pay Daiichi Sankyo a $125 million milestone payment.

AstraZeneca's AZD0780, a novel once-daily oral PCSK9 inhibitor, demonstrated significant results in the PURSUIT Phase IIb trial. The drug achieved a 50.7% reduction in LDL-C when administered with standard-of-care statin therapy, compared to placebo over 12 weeks.

The trial showed that 84% of participants receiving AZD0780 30mg reached their recommended LDL-C target (<70 mg/dL), versus only 13% in the control group. The effectiveness was consistent across moderate and high-intensity statin doses. The drug was generally well-tolerated, with adverse events comparable between treatment (38.2%) and placebo (32.6%) groups, and similar discontinuation rates (1.5% vs 2.3%).

DESTINY-Gastric05, a new phase 3 trial, has commenced with the first patient dosed to evaluate ENHERTU® (trastuzumab deruxtecan) in combination therapy for previously untreated HER2 positive advanced gastric cancer. The study will test ENHERTU with fluoropyrimidine chemotherapy and KEYTRUDA® versus the current standard treatment.

The trial focuses on patients with unresectable, locally advanced or metastatic HER2 positive gastric or gastroesophageal junction cancer with PD-L1 CPS ≥1. An exploratory cohort with PD-L1 CPS <1 will also be included. This initiative follows positive survival results from DESTINY-Gastric04 in second-line treatment.

ENHERTU, a HER2 directed DXd antibody drug conjugate jointly developed by Daiichi Sankyo and AstraZeneca, is currently approved in over 65 countries for second-line or third-line metastatic HER2 positive gastric cancer treatment.

AstraZeneca's IMFINZI (durvalumab) has received FDA approval as the first perioperative immunotherapy for muscle-invasive bladder cancer (MIBC) treatment in the US. The approval is based on the NIAGARA Phase III trial results, which demonstrated:

- 32% reduction in disease progression risk
- 25% reduction in death risk
- 67.8% of treated patients were event-free at two years
- 82.2% survival rate at two years

The treatment combines IMFINZI with gemcitabine and cisplatin before surgery, followed by IMFINZI monotherapy after bladder removal surgery. The therapy addresses a significant need, as over 20,000 people in the US were treated for MIBC in 2024. The treatment was well-tolerated, with manageable and mostly low-grade immune-mediated adverse events.

Lunit (KRX:328130.KQ) and AstraZeneca (AZN) will present a collaborative AI study at AACR 2025, showcasing the Lunit SCOPE Genotype Predictor. This deep learning model predicts EGFR mutations in non-small cell lung cancer (NSCLC) patients using H&E-stained tissue samples.

The study utilized the largest diverse training dataset to date, comprising over 12,000 pathology slides (>4,500 EGFR-mutated and >7,500 wild-type) from NSCLC patients across the US, China, and South Korea. The AI model demonstrated consistent performance across various clinical variables, including specimen types, EGFR mutation subtypes, slide scanners, and scan magnifications.

The technology aims to address current limitations in molecular testing accessibility for NSCLC patients, offering a rapid and cost-effective solution for predicting driver mutations. The presentation will take place at the AACR Annual Meeting from April 25-30, 2025, in Chicago.

AstraZeneca presented new study results at ELCC 2025 reinforcing TAGRISSO® (osimertinib) as a cornerstone therapy for EGFR-mutated non-small cell lung cancer (NSCLC). Key findings include:

The LAURA Phase III trial showed improved overall survival trend with TAGRISSO vs placebo in unresectable Stage III setting (58.8 vs 54.1 months). The SAVANNAH Phase II trial demonstrated 56% response rate combining TAGRISSO with savolitinib in patients with high MET levels after disease progression. The ORCHARD trial showed promising results combining TAGRISSO with datopotamab deruxtecan-dlnk, achieving up to 43% response rate.

The FLAURA2 trial analysis revealed progression-free survival of over two years when combining TAGRISSO with chemotherapy. Safety profiles across all trials were consistent with established data, though monitoring is required for potential serious side effects including interstitial lung disease, QT interval prolongation, and cardiomyopathy.