Innovent Biologics highlights subgroup of lung cancer patients in early-stage study of bispecific

Innovent Biologics reported Monday that 20.8% of advanced lung cancer patients saw their tumors shrink at least 30% after receiving an experimental bispecific antibody that’s meant to boost T cell activity.

In the Phase 1 study, the company included 125 total patients in the efficacy analysis. And it spotlighted the results from a subgroup of squamous non-small cell lung cancer patients, whose cancers typically start ​​in the central part of the lungs, at the World Conference on Lung Cancer on Monday.

In squamous NSCLC patients who received lower doses of the therapy, 6 of 27 (22%) had a confirmed partial response. Of those who received a higher dose, 9 of 29 (31%) had a confirmed response. Innovent also reported one unconfirmed partial response in the higher dose cohort.

The median progression-free survival in the low-dose group was 5.5 months, with a median follow-up of 7.5 months, while the median PFS in the higher-dose group was not reached.

Hui Zhou

In a statement, Innovent SVP Hui Zhou described the follow-up period for the higher 3 mg/kg dose group as short and noted that “more mature data” are expected.

Innovent said similar responses were seen in patients regardless of PD-L1 expression. The experimental drug, known as IBI363, is a bispecific that is designed to block the PD-1/PD-L1 pathway while activating the IL-2 pathway.

Jianya Zhou, the trial’s investigator and a professor at the Zhejiang University School of Medicine, said in a statement that effective treatment options for NSCLC patients who have failed immunotherapy are limited, and this therapy could “help overcome immune resistance.”

About 20% of patients experienced treatment-related adverse events that were grade 3 or higher, and 6% experienced a treatment-related event that resulted in them discontinuing treatment. The most common treatment-related adverse events were arthralgia, or joint soreness; anemia; hyper- and hypothyroidism; and rash, according to Innovent.

The company said the study is ongoing to determine the dose it plans to move into Phase 2 testing.