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JINAN, China, March 4, 2024 /PRNewswire/ — The European Society of Gynecological Oncology (ESGO) 2024 Conference has recently made selected abstracts available online. The abstract (abstract # 251) that details results from the Phase II clinical trial (DUBHE-C-206) evaluating the efficacy and safety of Qilu Pharmaceuticals’ iparomlimab and tuvonralimab (QL1706) in cervical cancer was selected for oral presentation on 8 March, local time.
Access the abstract here: https://emma.events/site/programme/?a=esgo2024&trackid=548#!
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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