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ESMO 2025 | Domvanalimab, zimberelimab and FOLFOX in 1L advanced GC/GEJC/EAC
Kohei Shitara, MD, National Cancer Center Hospital East, Kashiwa, Japan, comments on findings from arm A1 of the EDGE-Gastric trial (NCT05329766), which evaluated domvanalimab (anti-TIGIT) and zimberelimab (anti–PD-1) with FOLFOX in first-line advanced gastric, gastroesophageal junction, and esophageal adenocarcinoma (GC/GEJC/EAC). With over two years of follow-up, the combination demonstrated durable efficacy, including prolonged progression-free and overall survival, with responses observed regardless of PD-L1 status. The safety profile was consistent with anti–PD-1 therapy plus chemotherapy. This interview took place at the European Society for Medical Oncology (ESMO) 2025 Congress in Berlin, Germany.
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Transcript
This is a Phase two trial to test first-line chemotherapy with anti-PD-1 and anti-TIGIT combination. Interestingly, this TIGIT is modified with a silenced Fc portion, which is different from previous other TIGIT inhibitors like tiragolimab. Because of this silenced Fc portion, it mainly focuses on blocking of TIGIT without depletion of CD8 cells or Treg cells. And it more efficiently activates CD8 effector cells in preclinical study...
This is a Phase two trial to test first-line chemotherapy with anti-PD-1 and anti-TIGIT combination. Interestingly, this TIGIT is modified with a silenced Fc portion, which is different from previous other TIGIT inhibitors like tiragolimab. Because of this silenced Fc portion, it mainly focuses on blocking of TIGIT without depletion of CD8 cells or Treg cells. And it more efficiently activates CD8 effector cells in preclinical study. So in this study, in total, around 40 patients were enrolled, and it showed a promising overall response rate around 65%, and the median PFS exceeds one year. And there is a trend of a better outcome, especially in patients with PD-L1 or tumor proportion score 5 or higher population. This is quite reasonable because of the expected higher TIGIT or related molecule expression in PD-L1 positive or higher population. And the most impressive aspect of this result is overall survival. A median exceeds 26 or 27 months, which might be one of the longest median survivals in second-line study for HER2 negative population and a safety profile in line with that of chemo plus checkpoint inhibitor, so it just seems to be no increase with a combination with TIGIT inhibitors. To conclude, this combination, we are waiting for a top-line result of phase 3 STAT221 trial, which is currently comparing chemo plus TIGIT and PD-1 combination versus chemo and nivolumab as a current standard care. So let’s stay tuned.
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