Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its PD-1/IL-2α Bispecific Antibody Fusion Protein (R&D code: IBI363) for the treatment of unresectable locally advanced or metastatic melanoma (except choroidal melanoma) in patients who have progressed after at least one line of systemic therapy, which must include a PD-1/L1 inhibitor. Phase 1/2 clinical trials are currently underway in China, the U.S., and Australia to assess IBI363's efficacy and safety in various advanced malignant tumors.

At the ESMO Plenary meeting on June 14, 2024, Innovent presented promising efficacy signals in melanoma patients who had previously undergone immunotherapy: 37 patients with melanoma who had previously received immunotherapy received 1mg/kg of IBI363 and underwent at least one tumor evaluation after baseline, and 11 patients achieved objective responses, including 1 CR and 10 PR, with ORR and DCR of 29.7% and 73.0%, respectively. 

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, while melanoma is a rare malignant tumor, it has a high fatality rate, and its incidence is steadily increasing each 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."

Fast Track Designation (FTD) is a rapid review process designed to facilitate the clinical development of a drug that may treat serious conditions and fulfill an unmet medical need. According to regulations, drug candidates that obtain FTD qualifications will have more opportunities to communicate with the FDA during subsequent drug development and review processes, which will help speed up the clinical development and approval of the drug.