FDA Grants Fast Track Designation to IBI363 for Squamous NSCLC

The FDA has granted Fast Track Designation to IBI363, a first-in-class PD-1/IL-2^α-bias bispecific antibody fusion protein, for certain patients with squamous non–small cell lung cancer (sqNSCLC), according to an announcement from Innovent Biologics, Inc.

The designation is for patients with unresectable, locally advanced, or metastatic sqNSCLC that has progressed after anti-PD-L1 immune checkpoint inhibitor therapy and platinum-based chemotherapy.

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

For example, data presented on IBI363 at the World Conference on Lung Cancer showed there were “promising efficacy signals” in patients with sqNSCLC who previously received immunotherapy.

“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 [objective response rate] and DCR [disease control rate] at higher doses, along with a manageable safety profile,” Dr. Hui Zhou, senior vice president of Innovent, said in a statement.

In patients receiving IBI363, 3 mg/kg, the ORR was 50% among the 18 patients who had at least 12 weeks of follow-up or had completed the study. The disease control rate was 88.9% among these patients. The median progression-free survival (PFS) had not yet been reached and “remains under follow-up,” officials said. In patients receiving 1 mg/kg or 1.5 mg/kg, the median PFS was 5.5 months (95% CI, 1.5-8.3), with a 12-month PFS rate of 30.7%.

Across all dose groups, patients with a PD-L1 tumor proportion score of less than 1% (n=22) and those with a PD-L1 tumor proportion score of 1% or greater (n=22) “achieved encouraging ORRs of 36.4% and 31.8%, respectively, suggesting IBI363’s potential advantage in PD-L1 low-expression populations,” officials said.

Dr. Zhou explained the forthcoming data on the treatment and reflected on the implications of the overall data on IBI363.

“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,” Dr. Zhou said in a statement. “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.”

Clinical trials are currently underway in China, the United States, and Australia to evaluate its safety, tolerability, and preliminary efficacy in patients with advanced malignancies.

Source: Innovent Biologics, Inc.