Innovent’s IBI363 Gains FDA Fast Track Status for Squamous Non-Small Cell Lung Cancer Therapy
Tuesday, February 18, 2025
Innovent Biologics has received a second Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for its PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363.
IBI363 is an investigational PD-1/IL-2 bispecific antibody fusion protein developed by Innovent Biologics. It is designed to enhance therapeutic effects while minimising toxicity.
Lung cancer remains one of the most common and deadly cancers globally. Non-small cell lung cancer (NSCLC) accounts for over 80% of cases, with squamous cell carcinoma being a major subtype. Although antibody-drug conjugates (ADCs) have shown promise, large Phase 3 studies have yet to demonstrate sufficient efficacy in squamous NSCLC.
This designation applies to the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed after anti-PD-(L)1 immune checkpoint inhibitor therapy and platinum-based chemotherapy.
IBI363 continues to show potential in addressing treatment-resistant cancers. Higher doses have been associated with improved ORR and DCR, while safety remains manageable. The latest PFS data further support its potential long-term benefits.
IBI363 has also shown activity in other cancers, including colorectal cancer and mucosal melanoma. Its ability to target tumours with low or no PD-L1 expression suggests broader applications in oncology.
Fast Track Designation is a regulatory process designed to speed up the development and review of drugs intended for serious conditions with unmet medical needs.
This status allows increased interaction with the FDA, potentially accelerating the approval process.
The company plans to explore early-line treatment and combination therapies in future studies.
Source: innoventbio.com
