Qilu Pharma's PD-1/CTLA-4 Bispecific Combination Antibody Approved in China for Cervical Cancer

Sep 30, 2024 10:30 CST Updated 10:30

Qilu Pharmaceutical

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Today (September 30), the National Medical Products Administration (NMPA) of China announced,Qilu Pharmaceutical's Class 1 New DrugEpalumab Tovorinib InjectionThe marketing application has been approved.According to the public data from Qilu Pharmaceutical, this is aBifunctional Combination Antibody, byIgG4 Antibody Targeting PD-1Epalumab andIgG1 Antibody Targeting CTLA-4Tovorinib composition. The indication approved this time for the drug isFor the treatment of patients with recurrent or metastatic cervical cancer who have failed previous platinum-based chemotherapy.

Screenshot source:NMPA Official Website

Aipalolitovorelimab is a bifunctional combination antibody developed by Qilu Pharmaceutical. According to publicly available data from Qilu Pharmaceutical, this 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,Epalolumab-toripalimab has a synergistic mechanism of action that simultaneously blocks PD-1 and CTLA-4, while reducing the toxicity associated with CTLA-4 antibodies.。

In March 2024, Qilu Pharmaceutical announced that it will present at the European Society of Gynaecological Oncology (ESGO) Annual MeetingOral Report FormatPublishAipalolitovorelimab InjectionPhase 2 Clinical Study Results for the Treatment of Cervical Cancer. ThisIs a multi-center, single-arm phase 2 clinical trial, naEntryPatients with recurrent/metastatic cervical cancer who failed first-line platinum-based chemotherapy ± bevacizumab and have not received immunotherapy, administer Eparlito Vorrelizumab 5.0 mg/kg once every 3 weeks (Q3W) Injection treatment. This study enrolled a total of 148 subjects and was conducted across 38 centers in China.。

As of the data cutoff date, the median follow-up time was 11.0 months. The primary endpoint was evaluated by the Independent Review Committee (IRC).Objective Response Rate (ORR) was 33.8%, reaching the pre-specified primary endpoint. Secondary endpoints included,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).The study concluded that the aforementioned trial data indicate that Aipalolitovorelimab is effective and safe as a later-line treatment for recurrent/metastatic cervical cancer.

Public data shows that the preferred standard first-line treatment for recurrent or metastatic cervical cancer (r/mCC) is currently cisplatin or carboplatin combined with paclitaxel and bevacizumab.For PD-L1 positive r/mCC patients, it is recommended to use PD-1 inhibitors combined with chemotherapy ± bevacizumab as the first-line standard treatment.Although PD-1 inhibitors combined with chemotherapy significantly improved patient survival compared to chemotherapy alone, the survival benefit for patients remains relatively limited, indicating unmet clinical needs.

We hope that Qilu Pharmaceutical's innovative combination antibody therapy will reach patients as soon as possible, providing them with more treatment options.

References:

[1] NMPA Conditionally Approves Ipilimumab Injection for Market Launch From https://www.nmpa.gov.cn/zhuanti/cxylqx/cxypxx/20240930101946184.html

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

[3] Qilu Pharmaceutical's PD-1/CTLA-4 Combination Antibody New Drug QL1706 Phase I Clinical Study Results Published in International Authoritative Journal. Retrieved May 10, 2023 from https://mp.weixin.qq.com/s/IJLmlNH1-QUBS6QX0Lp-yw

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