Qilu Pharmaceutical's Iparomlimab and Tuvonralimab (QL1706) Demonstrates Efficacy and Safety in Recurrent or Metastatic Cervical Cancer in Phase II DUBHE-C-206 Trial, Selected for Oral Presentation at ESGO 2024

JinanMarch 1, 2024PR Newswire -- Recently, the European Society of Gynaecological Oncology (ESGO) 2024 conference has published all selected abstracts online. Among them, the abstract (#251) of the phase 2 clinical trial (DUBHE-C-206) results of Qilu Pharmaceutical's iparomlimab and tuvonralimab injection (QL1706) for cervical cancer has been selected for oral presentation (Presentation time: local time, March 8).

Abstract link:https://emma.events/site/programme/?a=esgo2024&trackid=548#!

This study was conducted at 38 centers in China, led by Professor Liu Jihong from the Sun Yat-sen University Cancer Center and Professor Lou Hanmei from Zhejiang Cancer Hospital. This is a multicenter, single-arm Phase II clinical trial that enrolled patients with recurrent/metastatic cervical cancer who had failed first-line platinum-based chemotherapy ± bevacizumab and had not received prior immunotherapy. Participants were treated with Aipalolituo Volirli monoclonal antibody at a dose of 5.0 mg/kg Q3W via injection. The study included a total of 148 participants. As of the data cutoff, the median follow-up time was 11.0 months. The primary endpoint, objective response rate (ORR) evaluated by the Independent Review Committee (IRC), was 33.8%, achieving the predefined primary endpoint. Among the secondary endpoints, the disease control rate (DCR) was 64.9%, progression-free survival (PFS) reached 5.4 months, and overall survival (OS) was not reached. A total of 104 participants (70.3%) experienced treatment-related adverse events (TRAEs). Thirty-six participants (24.3%) experienced TRAEs of grade ≥3, with anemia being the most common (4.1%). Three participants (2.0%) discontinued treatment due to TRAEs. No TRAEs led to death.

This study demonstrates that Epalumab Tovorali is effective and safe as a later-line treatment for recurrent/metastatic cervical cancer. In August last year, the marketing application of Epalumab Tovorali Injection was accepted by the CDE, marking it as the world's first PD-1/CTLA-4 targeted combination antibody to be submitted for marketing, which is expected to bring new hope to patients with cervical cancer.