Fast Track Designation from FDA for IBI363 as Monotherapy for Advanced Melanoma

Dr. Hui Zhou, Senior Vice President of Innovent, said, “Melanoma is the most common fatal skin cancer in Europe and the United States. In China, although melanoma is a rare malignant tumor, the case fatality rate is high, and the incidence is increasing year by year. Despite the success of immune checkpoint inhibitors in the treatment of melanoma, there is currently no drug approved for immunotherapy failed melanoma around the world, and the ORR of traditional chemotherapy ± anti-vascular therapy for immunotherapy failed melanoma is only 3.8% to 6.8%, with a median PFS of less than 3 months, and the benefit is very limited[1]-[2]. Therefore, there is an urgent clinical need for patients who have previously failed immunotherapy. As a First in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363 monotherapy has shown encouraging efficacy and a favorable safety profile in melanoma subjects who have previously received immunotherapy. We will continue to explore the efficacy and safety of IBI363 in melanoma to provide more effective clinical treatment for patients with immune-resistant melanoma.”