Precemtabart tocentecan (M9140) anti-CEACAM5 TOP1 ADC posts 21.7% PR rate in pretreated mPDAC

Precemtabart tocentecan (Precem‑TcT, M9140) is an anti‑CEACAM5 antibody–drug conjugate delivering an exatecan (TOP1 inhibitor) payload; interim data come from the Phase 1b/2 open-label PROCEADE‑PanTumor PDAC substudy (NCT06710132) in CEACAM5-high (≥50% tumor cells with IHC ≥2+) metastatic PDAC treated with 2.8mg/kg Q3W across the US/Australia/France/Japan/Korea. In 46 enrolled patients (mostly 2L/3L; largely irinotecan-pretreated), 10 achieved PR (21.7%), 20 SD (43.5%), and 11 PD (23.9%) as of January 2026, with mPFS not yet reported; this early ORR sits within/above typical benchmarks for 2L options (e.g., nal‑IRI+5‑FU/LV in NAPOLI‑1 improved outcomes vs 5‑FU/LV, with median PFS ~3.1 months and OS ~6.2 months in the post–gemcitabine setting). Safety was dominated by myelosuppression (grade ≥3 TEAEs 78.3%; neutropenia 43.5%, anemia 32.6%); GI AEs were mainly grade 1–2, dose reductions occurred in 15.2%, discontinuations in 4.3%, and there were no ILD/ocular toxicity signals or treatment-related deaths.