Discover how AstraZeneca and Amgen’s FDA proof-of-concept trials enable live data streaming of safety and efficacy endpoints, slashing development timelines while prioritizing patient safety in oncology.
Written By: Pharmacally Medical News Desk
The FDA announced proof-of-concept trials with AstraZeneca and Amgen on April 27, 2026, enabling real-time reporting of safety and efficacy endpoints to accelerate drug development and enhance patient safety monitoring. These pilots use AI and cloud technology via Paradigm Health’s platform to stream data signals, such as fevers or tumor responses, without accessing full patient-level data. A broader pilot program RFI was also issued, seeking input until May 29, 2026.
AstraZeneca Trial
AstraZeneca’s Phase 2 TRAVERSE trial (NCT05951959) tests Calquence (acalabrutinib), Venclexta (venetoclax), and rituximab (Rituxan) in treatment-naïve mantle cell lymphoma (MCL) patients. Sites include University of Texas MD Anderson Cancer Center and University of Pennsylvania; the FDA has received and validated real-time signals, proving the framework’s feasibility. Primary endpoint is minimal residual disease (MRD)-negative complete response rate after 13 cycles, with responders randomized to continued acalabrutinib or observation.
Amgen Trial
Amgen’s Phase 1b STREAM-SCLC trial (NCT05361395) evaluates Imdelltra (tarlatamab-dlle), a DLL3 T-cell engager, in limited-stage small cell lung carcinoma (SCLC) patients. Final site selection is ongoing, with agreed criteria for real-time safety and efficacy signal reporting to FDA. This builds on Imdelltra’s prior Phase 3 success in extensive-stage SCLC post-chemotherapy.
Implications
Real-time trials aim to cut “dead time” in paperwork, which consumes 45% of development timelines, potentially enabling continuous phases without pauses. FDA Commissioner Marty Makary emphasized faster regulatory decisions while maintaining traditional submissions initially. Experts note benefits for U.S. competitiveness but stress balancing speed with safety via pilots.
Reference
FDA Announces Major Steps to Implement Real-Time Clinical Trials | FDA