Fast Track Designation from the US FDA for IBI363 in Squamous NSCLC

Dr. Hui Zhou, Senior Vice President of Innovent, stated, “We are pleased that IBI363 has been granted Fast Track Designation by the FDA for sqNSCLC, following its previous designation for melanoma. Earlier, we reported that in an expanded cohort of sqNSCLC patients, IBI363 showed a trend toward improved ORR and DCR at higher doses, along with a manageable safety profile. The latest PFS data from the 3 mg/kg dose group after longer follow-up further strengthens our confidence in IBI363’s potential as an immunotherapy offering long-term benefits to patients. We will present the relevant data at upcoming academic conferences this year. More encouragingly, IBI363 has demonstrated potent anti-tumor activity regardless of PD-L1 expression levels. This suggests that IBI363 may not only advance treatment for immunotherapy-resistant populations but also for cold tumors with low or no PD-L1 expression. In addition to lung cancer, we have observed encouraging efficacy signals in cold tumors, including colorectal cancer and mucosal melanoma, with melanoma already advancing to pivotal clinical stages. Moving forward, we will continue to explore IBI363 in early-line treatment and in combination therapies.”