Results from the Clinical Trial of Qilu Pharmaceutical's Novel Anticancer Agent Iparomlimab and Tuvonralimab (QL1706) Featured in Oral Presentation at the ESGO Annual Meeting

This study was led by Professor Jihong Liu from the Sun Yat-sen University Cancer Center and Professor Hanmei Lou from the Zhejiang Cancer Hospital. This was a multi-center, single-arm, phase II study which recruited patients with recurrent or metastatic cervical cancer unresponsive to first-line platinum-based chemotherapy (with or without bevacizumab) and without prior immunotherapy. Participants received QL1706 at a dose of 5.0 mg/kg once every three weeks (Q3W). The study involved 38 medical centers across China and enrolled 148 patients, with a median follow-up of 11.0 months at the data cut-off. The primary endpoint, the objective response rate (ORR), as assessed by an Independent Evaluation Committee (IRC), was 33.8%, meeting the prespecified criteria. The disease control rate (DCR) was 64.9% and median progression-free survival (PFS) was 5.4 months. Overall survival (OS) was not reached. Treatment-related adverse events (TRAEs) occurred in 104 (70.3%) subjects, with 36 (24.3%)…

This study was led by Professor Jihong Liu from the Sun Yat-sen University Cancer Center and Professor Hanmei Lou from the Zhejiang Cancer Hospital. This was a multi-center, single-arm, phase II study which recruited patients with recurrent or metastatic cervical cancer unresponsive to first-line platinum-based chemotherapy (with or without bevacizumab) and without prior immunotherapy. Participants received QL1706 at a dose of 5.0 mg/kg once every three weeks (Q3W). The study involved 38 medical centers across China and enrolled 148 patients, with a median follow-up of 11.0 months at the data cut-off. The primary endpoint, the objective response rate (ORR), as assessed by an Independent Evaluation Committee (IRC), was 33.8%, meeting the prespecified criteria. The disease control rate (DCR) was 64.9% and median progression-free survival (PFS) was 5.4 months. Overall survival (OS) was not reached. Treatment-related adverse events (TRAEs) occurred in 104 (70.3%) subjects, with 36 (24.3%) experiencing grade ≥3 TRAEs. Anemia (4.1%) was the most common TRAE. Treatment discontinuation due to TRAEs occurred in three patients (2.0%). TRAE leading to death didn't occur.

The trial indicates that QL1706 is an effective and safe therapy for patients with recurrent or metastatic cervical cancer whose disease progressed after first-line standard of care. In August 2023, the China NMPA, Center for Drug Evaluation (CDE) accepted the new drug application for QL1706, making it the first MabPair product targeting PD-1 and CTLA-4 worldwide and a potential new treatment option for patients with cervical cancer.

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