China-based Qilu Pharmaceutical has published the latest results from a Phase II clinical study for QL1706, a dual-targeted antibody against programmed death 1 (PD-1) and cytotoxic T lymphocyte-associated antigen-4 (CTLA-4). The findings were presented at the Chinese Society of Clinical Oncology (CSCO) annual meeting.
Study Design and Results
Previous clinical studies have shown that QL1706 as a single agent demonstrated good initial efficacy and safety in the treatment of recurrent/metastatic cervical cancer. The open, non-randomized, multi-center Phase II study was designed to assess the safety and efficacy of QL1706 in combination with paclitaxel, cisplatin/carboplatin, and optionally bevacizumab in first-line recurrent/metastatic cervical cancer. The study enrolled 60 patients who received QL1706/chemo and QL1706/chemo/bevacizumab once every three weeks. After completing six cycles of chemotherapy, patients stopped chemotherapy and continued to receive QL1706 with or without bevacizumab until disease progression or intolerable toxicity.
The results indicated that the safety profile of QL1706 in combination with chemotherapy with or without bevacizumab was controllable, with no unexpected outcomes. A total of 57 patients were included in the efficacy analysis. The objective response rate (ORR) was 77.2%, and the disease control rate was 98.2%, demonstrating excellent anti-tumor activity. The median progression-free survival (PFS) and overall survival (OS) data were not mature by the data deadline.
Future Development
Based on these results, Qilu Pharmaceutical has initiated a Phase III study to further assess the efficacy and safety of QL1706 in combination with paclitaxel, cisplatin/carboplatin, and optionally bevacizumab in first-line recurrent/metastatic cervical cancer. This marks a significant step forward in the development of QL1706 as a potential treatment option for patients with cervical cancer.-Fineline Info & Tech
