Innovent shares new Phase 1 clinical data on IBI363
Innovent Biologics, Inc. (HKEX: 01801) announced a new milestone in its cancer research program, presenting Phase 1 clinical results for IBI363, a first-in-class PD-1/IL-2–bias bispecific antibody fusion protein being studied in advanced non-small cell lung cancer (NSCLC). The data were shared at a major global conference focused on lung cancer, underscoring ongoing efforts to bring new options to people facing this disease.
How IBI363 is designed to work
IBI363 takes a dual approach: it blocks the PD-1/PD-L1 pathway while activating the IL-2 pathway. By doing both at once, the bispecific antibody aims to boost tumor-specific T cell activity. The goal is straightforward—reinvigorate the immune response where it matters most and, in doing so, address an urgent need in NSCLC care.
Phase 1 study at a glance
The update centers on safety and early signs of efficacy. A total of 134 patients received IBI363 as monotherapy at doses up to 3 mg/kg every three weeks. Most had already been treated with PD-(L)1 immunotherapy, which provides useful context when evaluating the responses seen with IBI363.
With follow-up, the overall response rate (ORR) reached 20.8%, and the disease control rate (DCR) was 74.4%. Taken together, these results point to meaningful activity for a Phase 1 study in patients with advanced NSCLC.
Efficacy signals in key subgroups
Signals were especially encouraging among patients with squamous NSCLC. In the 3 mg/kg cohort, trends toward higher ORR and DCR were observed versus lower doses. Notably, among patients with longer follow-up in that cohort, the ORR reached 50%. While early, these findings suggest IBI363 could add value in this setting, particularly at the 3 mg/kg dose level.
Safety and tolerability
Safety was a central part of the presentation. Adverse events were manageable overall. The most common treatment-related events included arthralgia, anemia, hyperthyroidism, hypothyroidism, and rash. Most were mild to moderate in severity. This profile supports continued study of IBI363 in patients who often have limited options.
What this could mean—and what comes next
Innovent continues to evaluate IBI363 in ongoing clinical trials to better understand its safety, dosing, and potential benefit. As the dataset matures, the company plans to share more at upcoming academic meetings and through publications.
Professor Jianya Zhou of The First Affiliated Hospital emphasized how effective treatment can change the trajectory for people living with this difficult disease. With continued collaboration among investigators and Innovent’s team, the work aims to help reshape the NSCLC treatment landscape.
About Innovent Biologics
Founded in 2011, Innovent develops high-quality medicines across multiple therapeutic areas, including oncology. The company has 11 marketed products and additional programs in clinical development. Its partnerships with leading healthcare organizations reflect a commitment to broad access and to advancing innovative therapies for patients.
Frequently Asked Questions
What is IBI363?
IBI363 is a first-in-class bispecific antibody fusion protein that targets two immune pathways at once: it blocks PD-1 while engaging IL-2. This dual action is intended to activate tumor-specific T cells in advanced non-small cell lung cancer.
How was IBI363 tested in the Phase 1 study?
In this Phase 1 study, 134 patients received IBI363 as a monotherapy at doses up to 3 mg/kg every three weeks. Most had previously been treated with PD-(L)1 immunotherapy, offering a relevant benchmark for assessing IBI363’s activity.
What efficacy results were reported?
The study reported an overall response rate (ORR) of 20.8% and a disease control rate (DCR) of 74.4%. In the 3 mg/kg cohort—particularly among patients with extended follow-up—an ORR of 50% was observed in squamous NSCLC.
What did the safety profile look like?
Treatment-related adverse events were generally manageable. The most frequently reported were arthralgia, anemia, hyperthyroidism, hypothyroidism, and rash, with most events mild to moderate in severity.
What’s next for IBI363?
Innovent plans to continue clinical evaluation of IBI363 and to present additional data as it becomes available at future academic conferences and in publications.
