ESMO 2026 | Phase I trial of BGB-B2033, a GPC3 x 4-1BB bispecific antibody, in advanced HCC

This is a phase 1-2 study conducted mostly in Asia with a novel bispecific antibody, a bispecific antibody targeting GPC3 and FcγRIIIb for Fc-mediated effector functions, but more specifically GPC3 is a target that is overexpressed in approximately 90% of patients with HCC, so it’s an important target for HCC. And the study enrolled patients with heavily pretreated advanced HCC. This is an area of high unmet medical need because we have immunotherapy combinations in first line, but we don’t have really active or level one evidence agents for patients previously treated with immunotherapy. The study, as I said, is phase one, two. The results of 94 patients were presented and were heavily pretreated with a median number of prior treatment lines of two, but with a range up to eight. And 25% of the patients received three or more prior treatment lines, including immune checkpoint inhibitors, tyrosine kinase inhibitors, and combinations of both. So all the treatment options that we have for HCC. And the response rate is 36% with a long duration of response. 74% of the patients had a response maintained at six months. The safety profile is favorable. And both the efficacy and safety results compare very well with the results that we have with tyrosine kinase inhibitors after immune checkpoint inhibitors or with immune checkpoint inhibitors in this context. So these results are really promising and indeed a phase 3 study of BGB-A333 (not BGBB2033) compared with Lenvatinib or Sorafenib has been planned in patients with previously treated HCC and will be open soon.

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