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

Core Viewpoint - Innovent Biologics has initiated a pivotal study for IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, aimed at treating unresectable locally advanced or metastatic mucosal or acral melanoma, marking a significant advancement in immuno-oncology therapy in China [1][4][8]. Group 1: Study Details - The study is a randomized, multicenter trial comparing IBI363 monotherapy to pembrolizumab (Keytruda®) in patients who have not received prior systemic therapy [1]. - The primary endpoint of the study is progression-free survival (PFS), evaluated by an Independent Radiology Review Committee (IRRC) using RECIST v1.1 criteria [1]. Group 2: Efficacy and Safety - IBI363 has shown promising efficacy signals in earlier clinical trials, with an overall objective response rate (ORR) of 61.5% and a disease control rate (DCR) of 84.6%, indicating its potential superiority over current immunotherapy standards [2][6]. - The safety profile of IBI363 is manageable, with common treatment-related adverse events including arthralgia, anemia, thyroid dysfunction, and rash, all of which are manageable with routine clinical care [3]. Group 3: Clinical Need and Market Context - Melanoma has a high mortality rate in China, with a median PFS of only around three months for IO-naïve melanoma patients, highlighting a significant unmet clinical need [4]. - Non-cutaneous subtypes like mucosal melanoma are particularly resistant to existing immunotherapies, underscoring the importance of developing new treatment options like IBI363 [4][9]. Group 4: Company Overview - Innovent Biologics, founded in 2011, focuses on developing high-quality biopharmaceuticals for various diseases, including cancer, and has launched 14 products to date [10]. - The company is actively pursuing global development for IBI363 across multiple tumor types, aiming to extend the benefits of its innovations to patients worldwide [4][10].