China-based Qilu Pharmaceutical announced that the results of the Phase II study assessing its QL1604 plus chemotherapy as a first-line treatment for patients with recurrent or metastatic (R/M) cervical cancer were released on December 4, 2022, in an oral presentation (Proffered Paper, 179O) at the European Society for Medical Oncology (ESMO) Asia Congress 2022.
Study Design and Results
QL1604 is a highly selective, humanized monoclonal antibody that binds to PD-1. The study is a Phase II, open-label, single-arm study of QL1604 plus chemotherapy in patients with R/M cervical cancer (NCT04864782). Eligible patients received QL1604 200 mg plus chemotherapy (paclitaxel and cisplatin/carboplatin) once every 3 weeks (Q3W) for up to 6 cycles, and then QL1604 200 mg Q3W for maintenance therapy until disease progression or other discontinuation events. As of the data cut-off, 46 patients with R/M cervical cancer and naïve to systemic treatment were enrolled at 12 sites in China. Twenty (43.5%) patients previously underwent surgery and 40 (87%) patients previously received radiotherapy. Thirty-nine (84.8%) patients had recurrent disease and 7 (15.2%) patients had stage IV disease. QL1604 plus chemotherapy demonstrated a manageable safety profile, which was consistent with that reported for chemotherapy or anti-PD-1 therapy. The most common treatment-related adverse event was a decrease in white blood cell count.-Fineline Info & Tech
