New Treatment Option for Cervical Cancer: Iparomlimab and Tuvonralimab Injection Approved in China

Oct 08, 2024 16:00 CST Updated 16:00

Qilu Pharmaceutical

Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer

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On September 30, the National Medical Products Administration (NMPA) of China officially approved the marketing of Qilu Pharmaceutical's Class 1 new drug — Aipalolimab-Tovorolimab Injection. This innovative drug is a bifunctional combination antibody, combining Aipalolimab, an IgG4 antibody targeting PD-1, with Tovorolimab, an IgG1 antibody targeting CTLA-4, specifically for the treatment of patients with recurrent or metastatic cervical cancer who have failed prior platinum-based chemotherapy.

The uniqueness of Aipalolituo Volireli Monoclonal Antibody lies in its bifunctional design, which can simultaneously inhibit two key immune regulatory targets, PD-1 and CTLA-4. Moreover, the CTLA-4 antibody component in this drug has a shorter clearance half-life in the body, reducing the exposure time of the antibody in the body, thereby decreasing the potential toxicity of the CTLA-4 antibody while retaining its synergistic efficacy with the PD-1 antibody.

Qilu Pharmaceutical previously presented the Phase 2 clinical study results of this drug in cervical cancer treatment at the European Society for Gynaecological Oncology (ESGO) Annual Meeting. This multi-center, single-arm clinical trial enrolled 148 patients with recurrent/metastatic cervical cancer who had failed first-line platinum-based chemotherapy ± bevacizumab and had not received prior immunotherapy. The study results showed that in patients treated with Aipalolituo Vorilizumab, the objective response rate (ORR) reached 33.8%, the disease control rate (DCR) was 64.9%, and the progression-free survival (PFS) was 5.4 months. In terms of safety, 70.3% of patients experienced treatment-related adverse events (TRAE), but overall, the drug was considered effective and safe.

Currently, the standard first-line treatment for recurrent or metastatic cervical cancer (r/mCC) mainly includes cisplatin or carboplatin combined with paclitaxel plus bevacizumab. For PD-L1 positive r/mCC patients, PD-1 inhibitors combined with chemotherapy ± bevacizumab have become the standard first-line treatment. However, although this combination therapy has significantly improved patient survival compared to chemotherapy alone, the survival benefits for patients remain limited, and unmet clinical needs still exist.

The approval and marketing of Aipalolitovorelimab provide a new treatment option for patients with recurrent or metastatic cervical cancer, which is expected to bring better survival benefits and improved quality of life to patients.

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