Astrazeneca Plc - AZN STOCK NEWS

Puma Biotechnology presented clinical data for neratinib at the AACR Annual Meeting 2025 in Chicago. The Phase I trial (NCI 10495) evaluated the combination of neratinib with trastuzumab deruxtecan in patients with HER2-altered solid tumors.

Key findings from the 20-patient trial:

• Most common side effects: nausea (75%), diarrhea (75%), fatigue (65%)
• 4 patients achieved partial responses, including cases of gastroesophageal, pancreatic, and ovarian cancers
• Notable results in pancreatic cancer: 3 of 5 patients showed tumor shrinkage

The study established Dose Level 3 as the recommended Phase II dose: trastuzumab deruxtecan at 5.4 mg/kg combined with neratinib starting at 120 mg (week 1), increasing to 160 mg (week 2), and 240 mg (week 3 onward). Part 2 of the study, focusing on pharmacodynamic evaluation in 12 patients, began enrollment in March 2025.

SOPHiA GENETICS and AstraZeneca are expanding their collaboration to accelerate global liquid biopsy testing deployment. The partnership will extend MSK-ACCESS powered with SOPHiA DDM to 30 clinical institutions worldwide in 2025.

Key highlights:

• The liquid biopsy test detects genomic alterations from a single blood draw using advanced algorithms to analyze circulating tumor DNA
• This testing method offers advantages when traditional tissue biopsies are impractical due to cost, time, or invasiveness
• New data presented at AACR shows consistent accuracy across different laboratory settings

The expanded rollout supports AstraZeneca's real-world evidence initiatives and aims to validate decentralized liquid biopsy testing's clinical impact. The collaboration addresses a major industry challenge, as site-to-site result consistency has historically limited liquid biopsy adoption. Recent study results confirm the test maintains high analytical performance across multiple centers, matching the original standards set at Memorial Sloan Kettering Cancer Center.

Tempus AI (NASDAQ: TEM) has announced multi-year strategic collaborations with AstraZeneca and Pathos AI to develop the largest multimodal foundation model in oncology. The partnerships will focus on:

• Gathering biological and clinical insights
• Discovering novel drug targets
• Developing therapeutics for the oncology community

The agreements include $200 million in data licensing and model development fees to Tempus. The collaboration expands on Tempus' existing 2021 partnership with AstraZeneca, utilizing Tempus' AI-enabled platform and multimodal data repository to advance therapeutic programs in oncology globally. The foundation model will be built using Tempus' de-identified oncology data and will be shared among all three parties to enhance their respective patient care initiatives.

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.