▎Edited by the WuXi AppTec content team

Recently, Qilu Pharmaceutical Co., Ltd. announced that at the 2024 European Society of Gynaecological Oncology (ESGO) Annual Meeting, the company willOral Report FormatAnnouncement of Its Class 1 New DrugAipalolitovorelimab Injection（QL1706）Results of Phase 2 Clinical Trial for the Treatment of Cervical Cancer. The specific report time is March 8th, European local time.Aipalolitovorelimab is a PD-1/CTLA-4 targeted combination antibody, whose marketing application for cervical cancer was accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration in August 2023.

Source of screenshot: Reference [1]

Aipalolituo Vorilimumab is a bifunctional combination antibody developed by Qilu Pharmaceutical, consisting of Aipalolimumab, an IgG4 antibody targeting PD-1, and Tovorilimumab, an IgG1 antibody targeting CTLA-4. According to publicly available data from Qilu Pharmaceutical, this candidate drug can simultaneously inhibit PD-1 and CTLA-4. Moreover, the CTLA-4 antibody component has a shorter clearance half-life in the body and a relatively brief antibody exposure time within a dosing cycle. Therefore,Aipalolitovoreliumab has a synergistic mechanism of action that simultaneously blocks PD-1 and CTLA-4, while reducing the toxicity generated by CTLA-4 antibodies.。

It is reported that the study selected for oral presentation at ESGO is a multicenter, single-arm phase II clinical trial investigating...Patients with recurrent/metastatic cervical cancer who failed first-line platinum-based chemotherapy ± bevacizumab and have not received immunotherapy, participants received an injection of Aipalolituo Volarelimab at a dose of 5.0 mg/kg Q3W (once every three weeks). The study enrolled a total of 148 subjects and was conducted across 38 centers in China, led by the Sun Yat-sen University Cancer Center.Professor Liu Jihongand Zhejiang Cancer HospitalProfessor Lou Hanmei。

As of the data cutoff date, the median follow-up time was 11.0 months. The primary endpoint, evaluated by the Independent Review Committee (IRC),Objective Response Rate (ORR) was 33.8%, reaching the pre-specified primary endpoint. Secondary endpoints,The disease control rate (DCR) was 64.9%, and the progression-free survival (PFS) reached 5.4 months., Overall Survival (OS) was not reached.

In terms of safety, a total of 104 subjects (70.3%) experienced treatment-related adverse events (TRAE). Among them, 36 subjects (24.3%) had TRAE of grade 3 or higher, with the most common being anemia (4.1%). Three subjects (2.0%) discontinued treatment due to TRAE. No TRAE led to death.

The study concluded that the aforementioned trial data indicate that Eparlolibotuovirumab is effective and safe as a later-line treatment for recurrent/metastatic cervical cancer.

[1] Clinical Research Achievements of Qilu Pharmaceutical's Innovative Drug Eparlolib-Tovorilib Monoclonal Antibody Selected for Oral Presentation at ESGO Annual Meeting. Retrieved Mar 01, 2023 from https://mp.weixin.qq.com/s/XLRaxQy3tIAvisu-Q4Op9A