Innovent Biologics focuses on lung cancer patient subgroup in early bispecific study

Innovent Biologics announced that 20.8% of patients with advanced lung cancer experienced tumor shrinkage of at least 30% after receiving an experimental bispecific antibody designed to enhance T cell activity. This experimental drug, known as IBI363, aims to inhibit the PD-1/PD-L1 pathway while activating the IL-2 pathway.

In a Phase 1 clinical trial, 125 patients were included for efficacy analysis, with a particular focus on a subgroup of patients suffering from squamous non-small cell lung cancer (NSCLC). This type of cancer typically develops in the central part of the lungs. The results were presented at the World Conference on Lung Cancer.

For those with squamous NSCLC who were administered lower doses of the therapy, 6 out of 27 patients (22%) showed a confirmed partial response. In contrast, 9 out of 29 patients (31%) who received a higher dose also had a confirmed response, with one additional unconfirmed partial response in this higher dose group.

The median progression-free survival (PFS) for the low-dose group was recorded at 5.5 months, with a median follow-up of 7.5 months. For the higher-dose group, the median PFS had not been reached at the time of reporting. Innovent’s Senior Vice President Hui Zhou mentioned in a statement that the follow-up duration for the higher 3 mg/kg dose group was relatively short and that more comprehensive data are anticipated.

Interestingly, Innovent reported that similar responses were observed in patients, regardless of their PD-L1 expression levels. This suggests that IBI363 could potentially benefit a wide range of patients. According to Jianya Zhou, the trial's investigator and a professor at the Zhejiang University School of Medicine, treatment options for NSCLC patients who have not responded to immunotherapy are scarce, and this new therapy could potentially overcome immune resistance.

Approximately 20% of patients experienced treatment-related adverse events that were classified as grade 3 or higher. Of these, 6% had adverse events that led to discontinuation of the treatment. The most common side effects reported were joint soreness (arthralgia), anemia, and thyroid dysfunctions (both hyperthyroidism and hypothyroidism), along with skin rash.

The ongoing study aims to determine the appropriate dose to advance into Phase 2 testing. Innovent Biologics is optimistic that the data from the continued study will provide further insights into the efficacy and safety profile of IBI363, helping to refine and possibly expand treatment options for advanced lung cancer patients.

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