EC 200-015-4
Also known as Cytoxan.
Phase 3 trial of subcutaneous T‑cell‑engaging bispecific with R‑CHOP cut progression/death risk by 51% in newly diagnosed DLBCL (IPI 2–5); safety consistent with known profiles.
Phase III CELESTIMO showed a statistically significant, clinically meaningful progression‑free survival benefit for Lunsumio plus lenalidomide versus rituximab plus lenalidomide in relapsed/refractory FL after ≥1 prior therapy.
The trial's sole U.S. primary endpoint—overall survival—did not reach statistical significance; additional results will be submitted for peer review.
sBLA accepted for subcutaneous bispecific + ADC combo in relapsed/refractory large B‑cell lymphoma; FDA decision expected Feb 9, 2027.