On December 31, Gelonghui reported that SKB BIO-B (06990.HK) announced that the innovative humanized monoclonal antibody Tagolitamab (formerly known as KL-A167) for the treatment of recurrent or metastatic nasopharyngeal carcinoma patients who have previously failed second-line or higher chemotherapy has been approved by the National Medical Products Administration (NMPA) in China for market launch.
This approval is primarily based on an open-label, multi-center, Phase II clinical study conducted in patients with recurrent or metastatic nasopharyngeal carcinoma who previously failed second-line or higher systemic treatment, evaluating the efficacy and safety of Tagolitamab as a monotherapy. As of the data cut-off date, the median follow-up time was 21.7 months, with a total of 132 patients included in the full analysis set (FAS), the objective response rate (ORR) assessed by the independent review committee (IRC) was 26.5%, the median duration of response (DoR) was 12.4 months, and the median overall survival (OS) was 16.2 months. At the same time, Tagolitamab showed manageable safety, with grade 3 immune-related adverse events at 3.9%, and no grade 3 or higher immune-related adverse events were observed.