In today's ACT Brief, we examine AI's role as trial design advisor with human leadership, how to govern autonomous agents in regulated operations, and real-world outcomes from switching to oral weight-loss therapy.
News|Podcasts|December 23, 2025
ACT Brief: AI-Enabled Workflow Automation, Subcutaneous Lunsumio VELO Approval, and Pan-KRAS Early-Stage Development
Author(s)Andy Studna, Senior Editor
In today’s ACT Brief, we look at how AI-enabled workflows can automate existing site processes, review the FDA approval of subcutaneous Lunsumio VELO for relapsed or refractory follicular lymphoma, and examine early clinical development activity for a pan-KRAS inhibitor licensed by AstraZeneca.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In part four of an ACT video interview series, Kevin Williams of Ledger Run
discusses how AI can be applied to automate existing clinical operations workflows without introducing new processes for sites. He explains that AI-enabled automation can reduce manual steps across back-office functions while allowing sites to continue operating within familiar systems and workflows. Williams notes that these efficiencies are often implemented first at the sponsor or CRO level, with downstream operational benefits for sites. - The FDA has
approved subcutaneous Lunsumio VELO (mosunetuzumab) for adult patients with relapsed or refractory follicular lymphoma following two or more prior systemic therapies. The approval is based on data from the Phase I/II GO29781 trial, which demonstrated durable responses and a manageable safety profile in third-line or later disease. Lunsumio VELO is administered via one-minute subcutaneous injection and represents a new dosing option following the drug’s original intravenous approval in 2022. - AstraZeneca has
entered an exclusive global licensing agreement with Jacobio Pharma for the pan-KRAS inhibitor JAB-23E73, which has been evaluated in Phase I clinical trials in the US and China. The early-stage studies enrolled patients with advanced solid tumors harboring KRAS alterations and followed preclinical data showing broad KRAS mutation coverage. Phase I development is assessing safety, tolerability, and pharmacokinetics to support further clinical advancement.
That’s all for today’s ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
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