SPARK Just Ran 5,400-Patient Oncology Research Autonomously. Your Trial’s Biomarker Strategy Has Not Caught Up.
SPARK agentic AI validated prognostic biomarkers across 5,400 patients and 18 cancer types—here's what that means for trial enrichment...
BIOMEDE Missed Its Primary Endpoint — And Still Changed Pediatric CNS Trial Design Forever
The BIOMEDE Phase 2 trial in DIPG missed OS superiority but exposed a biomarker-survival link that should rewrite how...
Ewing Sarcoma’s EWS::FLI1 Trial Just Showed What Precision Oncology Has Been Promising for a Decade
A Nature Medicine phase 1/2 trial of trabectedin plus low-dose irinotecan targeting EWS::FLI1 in Ewing sarcoma signals a new...
The FDA Just Opened a Door in Anal Cancer Trials — And Most Sponsors Don’t Know It’s There
Oncolytics Biotech's Type C meeting request to discuss a single-arm registrational pathway for pelareorep in anal cancer is more...
The EMA’s Virtual Control Group Gambit Could Redraw the Map for Pivotal Trial Design
The EMA has opened consultation on a draft qualification opinion for virtual control groups — a methodology that, if...
One Biomarker, Two Diseases: The p-tau Signal That Just Complicated Your Stratification Strategy
A multicenter cross-sectional study in Nature Medicine shows serum p-tau—the cornerstone of Alzheimer's blood-based diagnostics—may also detect systemic amyloidoses....
Triplet Regimen, Biomarker Gate, Phase 3 Signal: What ILUSTRO’s Cohort 4 Actually Proves
Astellas's ILUSTRO trial just published Phase 2 data showing a zolbetuximab-nivolumab-mFOLFOX6 triplet in CLDN18.2-positive gastric cancer produces response rates...