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ESMO Asia 2025 | DEBATE: neoadjuvant durvalumab and chemotherapy in localized BTC
Changhoon Yoo, MD, PhD, Asan Medical Center, Seoul, South Korea, discusses the Phase II DEBATE study (NCT04308174) of neoadjuvant durvalumab combined with gemcitabine-cisplatin in patients with localized biliary tract cancer (BTC). Durvalumab added to gemcitabine-cisplatin improved R0 resection rates, progression-free survival, and objective response compared with gemcitabine-cisplatin alone. This interview took place at 2025 European Society for Medical Oncology (ESMO) Asia Congress in Singapore, Singapore.
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Transcript
The DEBATE trial is the investigative initiative trial conducted in Korea. The multi-center study was conducted at the two large-volume centers, Asan Medical Center and Samsung Medical Center. These trials, the preliminary, tried to see the efficacy and safety of the gemcitabine cisplatin plus doublet, which is now the standard care for the unresectable or the metastatic disease in patients with potentially resectable localized BTC...
The DEBATE trial is the investigative initiative trial conducted in Korea. The multi-center study was conducted at the two large-volume centers, Asan Medical Center and Samsung Medical Center. These trials, the preliminary, tried to see the efficacy and safety of the gemcitabine cisplatin plus doublet, which is now the standard care for the unresectable or the metastatic disease in patients with potentially resectable localized BTC. In this study, the gemcitabine plus doublet was compared with the gemcitabine, and they showed that the disease-free survival, progression-free survival was significantly better with the gem-cis plus durvalumab, but in terms of overall survival, there is no difference between the two groups. So there is some promise in terms of delaying some progression, but still we need a more stronger therapy to enhance, improve the overall survival. In the biomarker analysis, we could find that the gemcitabine cisplatin itself may reduce the immune cell subset, particularly for the monocyte. But with the addition of the durvalumab, it was reversed. It was improved. The immune cell subset was normalized with the additional immunotherapy. So the additional efficacy with the durvalumab, maybe later with that kind of thing. And finally, we could find some cytotoxic CD4 T-cell was significantly associated between the response group with the gem-cis versus compared to the non-responsive group with the GEM system. In this analysis, the PD-L1 expression was decreased with the significant responsive group. So we conclude that the additional anti-PD-L1 inhibition may enhance the current standard care, so GEMCIS plus durvalumab. That is our conclusion. And currently, the anti-PD-L1 plus NPD-1 bispecific antibody is currently under investigation in the adjuvant setting and the first-line setting in BTC. And we strongly support those clinical trials. That’s all.
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