China’s Center for Drug Evaluation (CDE) has indicated that US pharmaceutical giant Johnson & Johnson’s (J&J, NYSE: JNJ) GPRC5D/CD3 bispecific antibody (BsAb) talquetamab is on track to receive breakthrough therapy designation (BTD) for the treatment of recurrent or refractory (R/R) multiple myeloma (MM) in patients who have undergone at least three previous treatments, including a proteasome inhibitor, an immune modulator, and an anti-CD38 antibody.
Preclinical Efficacy of Talquetamab in Targeting Multiple Myeloma
Talquetamab is a first-in-class, off-the-shelf GPRC5D/CD3 BsAb that has demonstrated effectiveness in preclinical studies by effectively killing GPRC5D positive MM cell lines and promoting T cell infiltration. The drug is being developed for treatment-naive, previously treated, or relapsed/refractory patients, showcasing its versatility in addressing multiple stages of the disease.
Phase I Study Results Highlight Safety and Efficacy
A Phase I clinical study involving 232 patients revealed that common adverse events associated with talquetamab treatment included cytokine release syndrome and rash. The results showed that the 405 μg and 800 μg dose groups achieved remission rates of 70% and 64%, respectively, during a median follow-up period of 11.7 and 4.2 months. These findings underscore the potential of talquetamab as a promising therapeutic option for patients with advanced multiple myeloma.-Fineline Info & Tech
