May. 11 at 8:28 PM
$MAIA This is not what you asked for but I have a Chemistry / Biochemistry degree but lack expertise so asked four deep thought AI's to respond. Your thoughts on response especially the highlighted paragraph?
Interesting take on the THIO-104 control arm. Investigator’s choice of single-agent chemo (vinorelbine, gemcitabine, or docetaxel — if not previously exposed) is actually pretty standard for global Phase 3 trials in this exact population: 3L+ advanced NSCLC after CPI + chemo failure.
In that setting, true “standard of care” is fragmented. Many patients have already seen docetaxel or aren’t fit for combos. Ramucirumab + docetaxel is mostly a 2L option and isn’t uniformly available/reimbursed or suitable globally for heavily pre-treated pts. Using single-agent keeps the control clinically relevant, ethical, and feasible for regulators and sites.
HIGHLIGHT **MAIA’s Phase 2 (similar 3L post-CPI/chemo pts) showed median OS ~17.8 months with ateganosine sequenced to cemiplimab — vs historical chemo benchmarks of ~5–6 months in comparable later-line data. That’s a large delta they’re powering for. Even if the control arm does a bit better than pure historical numbers, success isn’t trivial.**
Your enrollment point is fair — open-label trials can face friction if investigators feel the control isn’t optimal for certain patients. But the design (1:1, up to ~300 pts, primary OS endpoint) was clearly discussed with regulators, and the Ph2 signal plus Fast Track status should help attract sites/patients who see the potential upside.
