Astrazeneca Plc Stock Price, News & Analysis

AstraZeneca (AZN) and Daiichi Sankyo reported positive TROPION-Breast02 phase 3 results: DATROWAY (datopotamab deruxtecan) improved median overall survival by 5.0 months versus investigator's choice chemotherapy (23.7 vs 18.7 months; HR=0.79; 95% CI: 0.64-0.98; p=0.0291) in first-line metastatic triple negative breast cancer patients for whom immunotherapy was not an option.

DATROWAY also cut risk of progression or death by 43% (PFS HR=0.57; p<0.0001), showed higher ORR (62.5% vs 29.3%), longer median DoR (12.3 vs 7.1 months), and had comparable rates of grade ≥3 TRAEs (33% vs 29%); one drug-related adjudicated grade 5 ILD occurred.

AstraZeneca (AZN) and Daiichi Sankyo reported positive DESTINY-Breast05 Phase III results on October 18, 2025 showing ENHERTU reduced risk of invasive disease recurrence or death by 53% versus T-DM1 (HR 0.47; 95% CI 0.34-0.66; p<0.0001).

At three years, IDFS was 92.4% with ENHERTU vs 83.7% with T-DM1. Results were consistent across prespecified subgroups. Key secondary endpoints (DFS, DRFI, BMFI) also favored ENHERTU. Overall survival was immature (2.9% maturity at cut-off 2 July 2025).

Safety aligned with known profile: Grade ≥3 AEs were similar (50.6% vs 51.9%); ILD rates were 9.6% with ENHERTU and 1.6% with T-DM1, mostly Grade 1–2.

AstraZeneca (AZN) and Daiichi Sankyo reported DESTINY-Breast05 Phase 3 results showing ENHERTU reduced the risk of invasive disease recurrence or death by 53% (HR=0.47; 95% CI 0.34–0.66; p<0.0001) versus T-DM1 as post-neoadjuvant therapy in high-risk HER2+ early breast cancer.

Three-year IDFS was 92.4% for ENHERTU vs 83.7% for T-DM1; three-year DRFI was 93.9% vs 86.1%. OS was immature (2.9% mature; HR=0.61). Safety was consistent with known profile: grade ≥3 TEAEs ~50.6% (ENHERTU) vs 51.9% (T-DM1); ILD occurred in 9.6% (ENHERTU) with two adjudicated grade 5 events (0.2%).

ENHERTU (AZN) showed a statistically significant improvement in neoadjuvant pathologic complete response (pCR) in DESTINY-Breast11: 67.3% vs 56.3% with ddAC-THP (Δ11.2%; 95% CI 4.0-18.3; p=0.003).

ENHERTU followed by THP also produced higher RCB (0+I) rates (81.3% vs 69.1%) and consistent pCR gains across HR+ and HR– subgroups. Safety was described as favorable versus ddAC-THP with lower rates of grade ≥3 TEAEs (37.5% vs 55.8%), serious AEs (10.6% vs 20.2%), treatment interruptions (37.8% vs 54.5%) and left ventricular dysfunction (1.3% vs 6.1%).

Event-free survival was immature (4.5% maturity) with an early trend favoring ENHERTU (HR=0.56). The ENHERTU monotherapy arm was closed early; a supplemental BLA for ENHERTU followed by THP is under FDA review.

AstraZeneca (NYSE:AZN) and Daiichi Sankyo reported DESTINY-Breast11 Phase III results showing neoadjuvant ENHERTU (fam-trastuzumab deruxtecan-nxki) followed by THP produced a pCR rate of 67.3% vs 56.3% with a ΔpCR of +11.2% (95% CI 4.0–18.3), p=0.003. Improvements were seen in HR-positive (61.4% vs 52.3%) and HR-negative (83.1% vs 67.1%) subgroups.

Resection outcomes showed RCB 0+I 81.3% vs 69.1%. Safety favored ENHERTU with lower Grade ≥3 AEs (37.5% vs 55.8%), serious AEs (10.6% vs 20.2%) and left ventricular dysfunction (1.3% vs 6.1%). EFS was immature (4.5% maturity) with an early HR 0.56 (95% CI 0.26–1.17). A supplemental BLA is under FDA review.

AstraZeneca (NYSE:AZN) announced on October 17, 2025 that TEZSPIRE (tezepelumab‑ekko) received FDA approval for add‑on maintenance treatment of adults and pediatric patients aged 12+ with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

Approval was based on the Phase III WAYPOINT trial showing statistically significant reductions in nasal polyp severity, near‑elimination of the need for surgery and reduced systemic corticosteroid use versus placebo. TEZSPIRE is the first biologic targeting TSLP approved for CRSwNP. Regulatory applications are under review in the EU, China, Japan and other countries.

AstraZeneca (AZN) and Daiichi Sankyo reported initial results from a TROPION-PanTumor03 sub-study showing DATROWAY (datopotamab deruxtecan) plus rilvegostomig produced a confirmed objective response rate (ORR) of 68.2% (95% CI: 45.1–86.1) and disease control rate (DCR) of 95.5% (80% CI: 83.4–99.5) in cisplatin-ineligible first-line metastatic urothelial cancer (n=22).

In the second-line, previously platinum-treated/immunotherapy-naïve cohort (n=18), ORR was 38.9% (95% CI: 17.3–64.3) and median progression-free survival (PFS) was 12.5 months (95% CI: 4.2–NR). Median duration of response was not reached in either cohort. Safety was consistent with known profiles: grade ≥3 treatment-related adverse events occurred in 18.2% (first-line) and 38.9% (second-line); adjudicated ILD events were 1 (4.5%) and 2 (11.1%), respectively.

AstraZeneca (NYSE:AZN) reported that the POTOMAC Phase III trial met its primary endpoint: adding one year of IMFINZI (durvalumab) to BCG induction and maintenance reduced the risk of high-risk non-muscle-invasive bladder cancer recurrence or death by 32% (DFS HR 0.68; 95% CI 0.50-0.93; P=0.0154) with median follow-up of 60.7 months. Estimated 24-month DFS rates were 86.5% (IMFINZI+BCG) vs 81.6% (BCG). OS was not formally powered; descriptive OS HR was 0.80 (95% CI 0.53-1.20) at 65.6 months. Grade 3‑4 adverse events occurred in 34% (IMFINZI arm) vs 17% (BCG). Results presented at ESMO 2025 and published in The Lancet.

AstraZeneca (NYSE:AZN) announced results from the MATTERHORN Phase III trial showing a perioperative IMFINZI (durvalumab) plus FLOT regimen reduced the risk of death by 22% versus chemotherapy alone (HR 0.78; 95% CI 0.63-0.96; P=0.021) in resectable Stage II–IVA gastric and gastroesophageal junction cancer. Median OS was not reached in either arm at data cut-off Sept 1, 2025. Estimated 3-year OS was 69% with IMFINZI-FLOT versus 62% with FLOT alone. Prior EFS analysis showed a 29% reduction in risk (HR 0.71; P<0.001).