Qilu Pharmaceutical, a Chinese pharmaceutical company, has announced that its combination drug QL1706, comprising iparomlimab and tuvonralimab, has received conditional marketing approval from the National Medical Products Administration (NMPA) for the treatment of recurrent or metastatic cervical cancer.
QL1706 (PSB205), originally developed by the U.S. biotech Qilu Puget Sound Biotherapeutic Corp., is a unique blend of anti-PD-1 and anti-CTLA-4 monoclonal antibodies derived from a single cell line using the company’s proprietary MabPair technology platform. This platform offers advantages over traditional bispecific antibodies.
The approval is supported by the results of a pivotal Phase II regulatory study (DUBHE-C-206), a multi-center, single-arm, open-label trial that enrolled 148 patients with recurrent or metastatic cervical cancer. The patients had failed first-line platinum-based chemotherapy ± bevacizumab and had not received prior immunotherapy. With a median follow-up time of 17.5 months, the study reported an objective response rate (ORR) of 33.3%, a disease control rate (DCR) of 65.3%, a median progression-free survival (PFS) of 5.4 months, and a median overall survival (OS) of 17.1 months, all based on independent review committee (IRC) assessment. In terms of safety, 107 patients (72.3%) experienced treatment-related adverse events (TRAEs), with 40 patients (27.0%) experiencing TRAEs of grade 3 or higher.
QL1706 is also under investigation in other clinical studies for multiple tumor types, including three Phase III clinical trials, with over 2000 subjects enrolled.- Flcube.com
