Astrazeneca Plc Stock Price, News & Analysis

AstraZeneca (NYSE:AZN) and Daiichi Sankyo have received FDA approval for DATROWAY® (datopotamab deruxtecan-dlnk), marking it as the first TROP2 directed therapy for previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC). The approval is based on the TROPION-Lung05 phase 2 and TROPION-Lung01 phase 3 trials, where DATROWAY showed a 45% objective response rate with a median duration of response of 6.5 months.

The drug received Priority Review and Breakthrough Therapy Designation from the FDA. Following this approval, AstraZeneca will pay a $45 million milestone payment to Daiichi Sankyo. This marks DATROWAY's second U.S. approval in less than six months, with Daiichi Sankyo recognizing U.S. sales.

AstraZeneca and Daiichi Sankyo have initiated the DESTINY-Endometrial01 phase 3 trial for ENHERTU in first-line treatment of HER2 expressing primary advanced or recurrent endometrial cancer. The study will evaluate ENHERTU combined with rilvegostomig or pembrolizumab versus standard platinum-based chemotherapy with pembrolizumab. The trial targets patients with HER2 expressing (IHC 3+/2+), mismatch repair proficient endometrial cancer, a condition affecting 18-56% of cases with a median survival of up to 30 months in advanced stages. This initiative follows positive results from the DESTINY-PanTumor02 study, which led to tumor agnostic approval for ENHERTU in previously treated HER2 positive metastatic tumors. The trial represents a significant step in addressing the unmet need in endometrial cancer treatment, where no HER2 directed medicines are currently approved for first-line therapy.

AstraZeneca and Daiichi Sankyo reported positive Phase III DESTINY-Breast09 trial results for ENHERTU plus pertuzumab as first-line treatment for HER2-positive metastatic breast cancer. The combination demonstrated a 44% reduction in disease progression or death risk versus standard THP therapy, with median progression-free survival of 40.7 months compared to 26.9 months. The objective response rate was 85.1% for ENHERTU plus pertuzumab versus 78.6% for THP, with 58 complete responses versus 33. The treatment showed consistent benefits across subgroups, with duration of response exceeding three years. Safety profile aligned with known profiles, with 12.1% of patients experiencing interstitial lung disease/pneumonitis, mostly low-grade. This marks the first significant improvement in first-line treatment outcomes for HER2-positive metastatic breast cancer in over a decade.

AstraZeneca and Daiichi Sankyo reported groundbreaking results from the DESTINY-Breast09 Phase 3 trial, showing ENHERTU plus pertuzumab significantly outperformed standard therapy in first-line HER2+ metastatic breast cancer treatment. The combination reduced disease progression or death risk by 44% versus THP (taxane, trastuzumab, pertuzumab), achieving a median progression-free survival of 40.7 months compared to 26.9 months. The objective response rate was 85.1% for ENHERTU plus pertuzumab versus 78.6% for THP, with more complete responses (58 vs 33). The safety profile aligned with known data, though ILD/pneumonitis occurred in 12.1% of patients. This marks the first improvement in first-line treatment outcomes for broad HER2+ metastatic breast cancer patients in over a decade, potentially establishing a new standard of care.

AstraZeneca and Daiichi Sankyo reported promising results for DATROWAY (datopotamab deruxtecan) in treating non-small cell lung cancer (NSCLC) across three clinical trials presented at ASCO 2025. In TROPION-Lung02, the combination of DATROWAY with pembrolizumab showed a 54.8% objective response rate in the doublet arm and 55.6% in the triplet arm including chemotherapy. TROPION-Lung04 demonstrated a 57.5% response rate when combining DATROWAY with rilvegostomig. The NeoCOAST-2 trial showed encouraging results in early-stage NSCLC with a 35.2% pathologic complete response rate when combining DATROWAY with durvalumab and chemotherapy. Safety profiles were consistent with previous studies, with manageable adverse events including some cases of interstitial lung disease.

AstraZeneca's IMFINZI (durvalumab) in combination with FLOT chemotherapy demonstrated significant success in treating early-stage gastric and gastroesophageal junction cancers in the MATTERHORN Phase III trial. The perioperative treatment showed a 29% reduction in disease progression, recurrence, or death risk compared to chemotherapy alone. At two years, 67.4% of IMFINZI-treated patients remained event-free versus 58.5% in the comparator arm. The trial also showed a strong trend toward improved overall survival (HR=0.78). The IMFINZI-based regimen more than doubled the pathologic complete response rate (19% vs 7%). The safety profile was consistent with known profiles, with similar Grade 3 or higher adverse events between arms. This marks IMFINZI as the first and only immunotherapy to show statistically significant event-free survival in a global Phase III trial for this indication.

AstraZeneca's SERENA-6 Phase III trial demonstrated significant success for camizestrant in treating HR-positive breast cancer. The drug, combined with CDK4/6 inhibitors, reduced disease progression or death risk by 56% compared to standard treatment, with median progression-free survival of 16.0 months versus 9.2 months. The trial marked the first use of circulating tumor DNA monitoring to detect and treat emerging resistance before disease progression. Camizestrant also improved quality of life metrics, delaying deterioration by 23.0 months compared to 6.4 months with standard treatment. The safety profile was consistent with known profiles, though Grade 3 adverse events were higher in the camizestrant arm (60% vs 46%). Based on these results, the FDA granted Breakthrough Therapy Designation for camizestrant in combination with CDK4/6 inhibitors for HR-positive, HER2-negative advanced breast cancer patients with ESR1 mutations.

AstraZeneca and Daiichi Sankyo's ENHERTU demonstrated superior efficacy in the DESTINY-Gastric04 phase 3 trial for second-line HER2-positive gastric cancer treatment. The drug showed a 30% reduction in death risk compared to ramucirumab plus paclitaxel, with median overall survival of 14.7 vs 11.4 months. ENHERTU achieved significant improvements across key metrics: 26% reduction in disease progression risk, 44.3% objective response rate (vs 29.1%), and 7.4 months median duration of response (vs 5.3 months). The safety profile remained consistent with previous trials, though interstitial lung disease occurred in 13.9% of ENHERTU patients, mostly low-grade. These results position ENHERTU as a potential global standard of care for second-line treatment in HER2-positive gastric cancer patients.

Danaher (NYSE: DHR) has announced a strategic partnership with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop and commercialize advanced diagnostic tools for precision medicine. The collaboration will leverage Danaher's Centers for Enabling Precision Medicine and technology from its subsidiary, Leica Biosystems, focusing initially on digital and computational pathology products with AI-assisted algorithms.

The partnership aims to create diagnostic tests that help identify patients most likely to benefit from targeted therapies. Leica Biosystems will utilize its global laboratory network to deploy these tests worldwide, supported by its commitment to open-access DICOM standards for enhanced workflow connectivity.