AstraZeneca (AZN) Stock News

AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo announced that ENHERTU® in combination with pertuzumab has received Breakthrough Therapy Designation (BTD) from the FDA for first-line treatment of HER2 positive metastatic breast cancer.

The designation is based on data from the DESTINY-Breast09 phase 3 trial, which demonstrated a remarkable median progression-free survival of more than three years when using ENHERTU plus pertuzumab. This represents a significant improvement over the current standard of care that has been used for over a decade.

This marks ENHERTU's ninth BTD overall and fifth BTD for metastatic breast cancer, highlighting the drug's expanding potential in cancer treatment. It is also Daiichi Sankyo's thirteenth BTD across its oncology portfolio.

AstraZeneca (NYSE:AZN) announced positive Phase III trial results for baxdrostat, a potential first-in-class aldosterone synthase inhibitor for treating uncontrolled or treatment-resistant hypertension. The BaxHTN trial, involving 796 patients, demonstrated that both 2mg and 1mg doses achieved statistically significant and clinically meaningful reductions in systolic blood pressure compared to placebo at 12 weeks.

The trial successfully met its primary endpoint and all secondary endpoints, with baxdrostat showing a favorable safety profile. This breakthrough is particularly significant as 50% of US hypertensive patients on multiple treatments still struggle with blood pressure control, and globally, 1.3 billion people live with hypertension.

AstraZeneca (NYSE:AZN) has received US FDA approval for DATROWAY® (datopotamab deruxtecan-dlnk) to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.

The approval, granted under accelerated approval based on objective response rate (ORR) of 45% and duration of response (DoR) of 6.5 months, follows Priority Review and Breakthrough Therapy Designation. DATROWAY becomes the first and only TROP2-directed therapy approved in the US for lung cancer treatment.

The safety profile was evaluated in 125 patients across multiple trials, with no new safety concerns identified. A milestone payment of $45 million is due from AstraZeneca to Daiichi Sankyo following this approval.

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.