Also known as: ESMO
At ESMO GI 2026, experts presented the EBAI framework classifying AI-based biomarkers into three validation tiers. Clinical data showed AI detecting MSI with 96-98% sensitivity and MRI-guided brachytherapy improving recurrence-free survival.
The FDA has cleared CStone Pharmaceuticals' investigational new drug application to begin a Phase II trial of its trispecific antibody CS2009 in advanced solid tumors. The multicenter trial will evaluate monotherapy and combination regimens across nine cancer types in Australia, China, and the U.S. Initial Phase I data showed a favorable safety profile and encouraging antitumor activity.
Dual immunotherapy allowed 70.6% of MSI-H gastric cancer patients to avoid surgery in the INFINITY trial. German off-label immunotherapy shows 20-25% response rates, requiring careful patient selection.
European guidelines now recommend lutetium-177 PSMA-617 for advanced prostate cancer, while a machine-learning model predicts treatment radiation dose. A study finds DOACs safe with modern prostate cancer drugs.
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
Novartis reported Phase III PSMAddition data showing Pluvicto plus standard of care cut the risk of PSA progression by 58% in PSMA-positive metastatic hormone-sensitive prostate cancer. Regulatory decisions in the United States, China and Japan are expected in the second half of 2026.
PARP inhibitors remain strongest in BRCA1/2-altered tumors as use beyond that group has been uneven. In June 2025, the FDA narrowed Zejula’s first-line ovarian maintenance indication to HRD-positive tumors only.
Trastuzumab deruxtecan is moving into earlier treatment lines for HER2-positive metastatic breast cancer, demonstrating superior efficacy over standard regimens and prompting reconsideration of long-standing treatment sequences.
The US FDA granted priority review and the European Medicines Agency validated applications for Enhertu as post-neoadjuvant treatment for HER2-positive early breast cancer, based on Phase III trial data showing 53% reduction in recurrence risk.
Final analysis of Merck's Phase 3 KEYNOTE-B96 trial shows KEYTRUDA plus paclitaxel with or without bevacizumab significantly improved overall survival in platinum-resistant recurrent ovarian cancer patients, reducing death risk by 18%.
