FDA has granted Fast Track Designation(FTD) to Innovent Biologics’ PD-1/IL-2α-bias Bispecific Antibody Fusion Protein (IBI363) for treating unresectable locally advanced or metastatic melanoma.
This designation applies to melanoma patients who have experienced disease progression on or after at least one line of systemic therapy, which must include a PD-1/L1 inhibitor.
IBI363 was tested in Phase 1/2 trials across China, the US, and Australia, offering hope to patients with advanced melanoma.
The FDA’s FTD for IBI363 underscored the potential of this investigational treatment to improve outcomes for patients with advanced melanoma.
Dr. Hui Zhou, SVP of Innovent, acknowledged the significant unmet medical need in melanoma treatment, particularly for patients who have experienced immunotherapy failure.
He emphasized the limitations of current treatment options for the melanoma patient population, noting that existing therapies offer limited benefit, with a median progression-free survival (PFS) of less than three months and an objective response rate (ORR) of only 3.8% to 6.8%.
Dr. Zhou highlighted the potential of IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein, as a promising therapeutic option for this patient group.
Source: Innovent Receives Fast Track Designation from the U.S. FDA for IBI363 (PD-1/IL-2α-bias Bispecific Antibody Fusion Protein) as Monotherapy for Advanced Melanoma
https://www.innoventbio.com/InvestorsAndMedia/PressReleaseDetail?key=480
