Innovent Biologics has received its second Fast Track Designation (FTD) from the US Food and Drug Administration (FDA).

This designation applies to the treatment of unresectable, locally advanced, or metastatic squamous non-small cell lung cancer (sqNSCLC) that has progressed following anti-PD-(L)1 immune checkpoint inhibitor therapy and platinum-based chemotherapy.

IBI363 has demonstrated encouraging efficacy and safety across multiple solid tumor types. Currently, Innovent is conducting Phase 1/2 clinical trials of IBI363 mainly in China and the U.S.

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."

Fast Track Designation (FTD) is a regulatory process designed to expedite the clinical development and review of drugs intended to treat serious conditions and address unmet medical needs. Drug candidates granted FTD benefit from increased communication with the FDA throughout subsequent drug development, potentially accelerating their clinical development and approval process.