# PANKU-Esophagus01 (BL-B01D1-305)

Source: https://onco.cc/trials/panku-esophagus01/  
OnCo record `panku-esophagus01` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first bispecific ADC to extend both progression-free and overall survival in oesophageal cancer, for patients whose immunotherapy has stopped working.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Registry id: NCT06304974
- Phase: 3
- Setting: Recurrent or metastatic oesophageal squamous cell carcinoma after PD-(L)1 inhibitor plus platinum chemotherapy: izalontamab brengitecan vs chemotherapy of physician's choice
- Sponsor: SystImmune / BMS
- Enrolled: 497
- Result: OS and PFS significantly improved at interim analysis; numbers per ASCO 2026 presentation.
- Outcomes: Overall survival: Izalontamab brengitecan 9.8 months vs Chemotherapy (physician's choice) 7.2 months, HR 0.64; Progression-free survival (BICR): Izalontamab brengitecan 4.2 months vs Chemotherapy (physician's choice) 2 months, HR 0.5
- Replication: Single Chinese phase 3 (ASCO 2026 oral; NMPA approval July 2026); consistent with the positive iza-bren phase 3s in nasopharyngeal carcinoma and TNBC (BL-B01D1-307). No data outside China yet.

## Sources

- ClinicalTrials.gov NCT06304974: https://clinicaltrials.gov/study/NCT06304974
- Announcement: https://www.biospace.com/press-releases/izalontamab-brengitecan-iza-bren-demonstrates-statistically-significant-and-clinically-meaningful-improvements-in-overall-survival-and-progression-free-survival-in-patients-with-triple-negative-breast-cancer-and-esophageal-squamous-cell-carcinoma

## Connected records

- cancers: [Oesophageal cancer](https://onco.cc/cancers/esophageal/)
- technologies: [Bispecific ADC](https://onco.cc/technologies/bispecific-adc/)
- targets: [EGFR](https://onco.cc/targets/egfr/), [HER3](https://onco.cc/targets/her3/)
- drugs: [Izalontamab brengitecan](https://onco.cc/drugs/izalontamab-brengitecan/)
- trials: [BL-B01D1-307](https://onco.cc/trials/bl-b01d1-307/)

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