PANKU-Esophagus01 (BL-B01D1-305)
The first bispecific ADC to extend both progression-free and overall survival in oesophageal cancer, for patients whose immunotherapy has stopped working.
Interim analysis met dual primary endpoints of OS and BICR-assessed PFS (announced February 2026; presented ASCO 2026). 249 vs 248 patients. Second-line ESCC previously had only single-agent chemotherapy (irinotecan, taxanes) with median OS under a year. Global confirmatory trials are being planned.
Setting
Recurrent or metastatic oesophageal squamous cell carcinoma after PD-(L)1 inhibitor plus platinum chemotherapy: izalontamab brengitecan vs chemotherapy of physician's choice
Phase
Phase 3
Sponsor
SystImmune / BMS
Registry
Headline result
OS and PFS significantly improved at interim analysis; numbers per ASCO 2026 presentation.
Reported
2026
Enrolled
497
Replication
Parallel positive phase 3 in TNBC (BL-B01D1-307) supports the agent; no second ESCC trial yet.
Pages like this
not linked directly; found by shared links- CompanySystImmune / Sichuan Biokin
Shares Izalontamab brengitecan, Bispecific ADC, Oesophageal cancer.
- IdeaTwo-target antibody drugs to close the antigen escape route
Shares Izalontamab brengitecan, Bispecific ADC.
- PersonHelena A. Yu
- ProductTilatamig samrotecan
Shares Bispecific ADC, EGFR.
- InstitutionAichi Cancer Center
Shares EGFR, Oesophageal cancer.
- RoadmapADC roadmap: from Mylotarg to bispecific and dual-payload ADCs
Shares BL-B01D1-307, Izalontamab brengitecan, Bispecific ADC.
- InstitutionShanghai Chest Hospital
Shares EGFR, Oesophageal cancer.
- InstitutionSun Yat-sen University Cancer Center