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Head-to-Head Against Pembrolizumab: Innovent Announces First Patient Dosed in the First Pivotal Study of IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) in Melanoma
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, announced that the first patient has been dosed in its registrational study evaluating IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, as monotherapy versus pembrolizumab (Keytruda®) in patient
About this update from Innovent Biologics, Inc.
[{"type":"text","content":"SAN FRANCISCO and SUZHOU, China, March 3, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, ophthalmology, and other major diseases, announced that the first patient has been dosed in its registrational study evaluating IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, as monotherapy versus pembrolizumab (Keytruda®) in patients with unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. This is IBI363's first pivotal study and a significant milestone for China's innovative immuno-oncology (IO) therapy in addressing the global challenge of treating "cold tumors."","length":897,"tagName":"p"},{"type":"text","content":"This is a randomized, multicenter, pivotal study designed to evaluate the efficacy and safety of IBI363 monotherapy versus pembrolizumab monotherapy in patients with unresectable, locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. The primary endpoint is progression-free survival (PFS), as assessed by an Independent Radiology Review Committee (IRRC) based on RECIST v1.1 criteria.","length":434,"tagName":"p"},{"type":"text","content":"IBI363 has demonstrated outstanding efficacy signals in immunotherapy (IO)-naïve melanoma patients across two earlier clinical trials (Phase 1a/1b study NCT05460767 and Phase 2 study NCT06081920), which enrolled a total of 26 patients with advanced acral or mucosal melanoma:","length":280,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"The overall objective response rate (ORR) was 61.5%, and the disease control rate (DCR) was 84.6%—significantly higher than current domestic immunotherapy standards.","length":165,"tagName":"p"}]},{"val":[{"type":"text","content":"Prolonged follow-up revealed sustained tumor responses and long-term benefits, suggesting the potential superiority of IBI363 over existing standard therapies.","length":159,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":324,"olType":false},{"type":"text","content":"These preliminary data were presented at SITC ...