Qilu Pharmaceutical Initiates Phase II/III Trial of PD-1/CTLA-4 Bispecific Antibody QL1706 Versus Sintilimab in First-Line Hepatocellular Carcinoma

On August 1, the Drug Clinical Trial Registration and Information Disclosure Platform showed that Qilu Pharmaceutical Co., Ltd. initiated a randomized, controlled, open-label, multicenter Phase II/III clinical study (CTR20232313) comparing QL1706 combination therapy with sintilimab combined with bevacizumab as first-line treatment for patients with advanced hepatocellular carcinoma.

QL1706 is a bifunctional combination antibody developed by Qilu Pharmaceutical using the novel combination antibody technology platform MabPair. It simultaneously produces two engineered monoclonal antibodies in a single cell at a ratio of approximately 2:1 — the programmed death receptor-1 (PD-1) IgG4 antibody Iparomlimab and the cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) IgG1 antibody Tuvonralimab. Thus, QL1706 can simultaneously inhibit PD-1 and CTLA-4. Moreover, the CTLA-4 antibody component has a shorter clearance half-life in vivo, resulting in reduced exposure time of the CTLA-4 antibody within a dosing cycle. Therefore, QL1706 demonstrates a synergistic mechanism of action by blocking both PD-1 and CTLA-4 while reducing the toxicity associated with the CTLA-4 antibody.

The Phase II part of the study aims to evaluate the efficacy and safety of QL1706 in combination with bevacizumab and chemotherapy compared to QL1706 combined with bevacizumab or QL1706 combined with chemotherapy as first-line treatment for patients with advanced HCC, and to provide a basis for selecting the experimental group in the Phase III clinical research. The primary endpoints of the Phase II study include: 1) Objective Response Rate (ORR) assessed by investigators according to RECIST v1.1; 2) Adverse events, adverse events during treatment, grades, incidence, severity of serious adverse events, and their correlation with the investigational drug; changes in vital signs, physical examinations, 12-lead electrocardiograms, and laboratory tests.

The Phase III part aims to evaluate the overall survival (OS) of QL1706 combination therapy compared with sintilimab combined with bevacizumab as first-line treatment for patients with advanced hepatocellular carcinoma, which is also the primary endpoint of the Phase III study.

Notably, Qilu Pharmaceutical registered another head-to-head study of QL1706 (CTR20223309) in December 2022, aiming to compare the efficacy of QL1706 combined with chemotherapy versus tislelizumab combined with chemotherapy as a first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer who are PD-L1 negative. The primary endpoints include progression-free survival (PFS) and overall survival (OS).

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