Chinese biopharmaceutical company Innovent Biologics Inc (HKEX:01801) announced on Sunday that the first patient has been dosed in its registrational study of IBI363, a first-in-class PD-1/IL-2 alpha-bias bispecific antibody fusion protein.
IBI363 is being evaluated as a monotherapy compared to pembrolizumab (Keytruda) in patients with unresectable locally advanced or metastatic mucosal or acral melanoma who have not received prior systemic therapy. This is the first pivotal study of IBI363 and a significant milestone for China's innovative immuno-oncology (IO) therapy in addressing the global challenge of treating 'cold tumours'.
The primary endpoint of the study is progression-free survival (PFS), as assessed by an Independent Radiology Review Committee based on RECIST v1.1 criteria.
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