Datopotamab deruxtecan

• AstraZeneca will present over 80 abstracts at ASCO 2025, including two plenary presentations featuring camizestrant for HR-positive breast cancer and IMFINZI for early gastric cancer, marking their seventh consecutive year with plenary data. • The SERENA-6 trial is the first positive Phase III study for a next-generation oral SERD in first-line HR-positive breast cancer, pioneering the use of circulating tumor DNA to guide treatment decisions. • DESTINY-Breast09 data shows ENHERTU plus pertuzumab is the first treatment in over a decade to demonstrate superiority over standard care in first-line HER2-positive metastatic breast cancer.

• AstraZeneca has received European Union approval for DATROWAY, a significant advancement in breast cancer treatment, despite experiencing a 3.5% share price decline in the last quarter. • The pharmaceutical giant also secured EU approval for Imfinzi in non-small cell lung cancer, strengthening its oncology portfolio as part of its strategy to develop 20 new medicines by 2030. • A $125 million milestone payment is due to Daiichi Sankyo, highlighting the strategic partnership behind these oncology advancements amid broader market volatility affecting the pharmaceutical sector.

• Four prominent oncologists highlight that antibody-drug conjugates (ADCs), while revolutionary, require careful management of unique toxicity profiles specific to each drug. • The tumor-agnostic approval of Enhertu (T-DXd) in 2024 marks a significant advancement, with 14 FDA-approved ADCs now available and over 100 in development. • Experts emphasize the importance of comprehensive genomic profiling and proactive toxicity management to maximize therapeutic benefits while ensuring patient safety.

New research from MD Anderson's X-Met consortium demonstrates metastasis-directed therapy improves survival rates to 92% at three years compared to 86% with standard care in oligometastatic prostate cancer patients.

• The TROPION-Lung12 phase 3 trial has begun, assessing adjuvant DATROWAY® (datopotamab deruxtecan) with or without rilvegostomig in resected stage 1 NSCLC patients. • The trial targets patients with ctDNA-positive status or high-risk pathological features, aiming to improve outcomes after surgery for early-stage non-small cell lung cancer. • DATROWAY®, a TROP2-directed antibody-drug conjugate, is being evaluated against standard of care to prevent disease recurrence in this high-risk population. • This global, multicenter trial will enroll approximately 660 patients across Asia, Europe, North America, and South America to evaluate disease-free survival.