ALPHAMAB-B(09966): JSKN033 has received approval from CDE to conduct a Phase III clinical study for the treatment of cervical cancer.

ALPHAMAB-B (09966) announced that JSKN033 (a high-concentration subcutaneous formulation composed of a bispecific antibody-drug conjugate targeting human epidermal growth factor receptor 2 (HER2) and a programmed death ligand 1 (PD-L1) immune checkpoint inhibitor) has obtained approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China to conduct a Phase III clinical study (Study Number: JSKN033-301) for monotherapy in patients with recurrent or metastatic cervical cancer who have failed platinum-based chemotherapy and PD-1/PD-L1 inhibitor treatment. Globally, cervical cancer has the highest incidence among gynecological malignancies and is the fourth leading cause of cancer death in women. Patients with locally advanced and high-risk early-stage disease are prone to recurrence and metastasis after treatment, with a five-year survival rate of less than 20% in advanced cases. Immune therapy combined with platinum doublet chemotherapy (with or without bevacizumab) is recommended as a first-line standard regimen by authoritative guidelines both domestically and internationally. However, most patients still experience disease progression due to resistance. Currently, there are no very effective treatment options outside of chemotherapy for cervical cancer patients who have failed both first-line platinum chemotherapy and PD-1/PD-L1 inhibitor therapy. JSKN033-301 is a randomized, controlled, open-label, multicenter Phase III clinical study aimed at evaluating the efficacy and safety of JSKN033 compared to investigator-selected chemotherapy in patients with recurrent or metastatic cervical cancer who have failed platinum-based chemotherapy and PD-1/PD-L1 inhibitor treatment.