Innovent Presents IBI363 Clinical Data on Advanced NSCLC and Solid Tumors at 2024 ESMO Virtual Plenary

Innovent Biologics, Inc., a prominent biopharmaceutical company, recently presented clinical data on its novel drug, IBI363, during the 2024 ESMO Virtual Plenary. IBI363 is a pioneering PD-1/IL-2α-bias bispecific antibody fusion protein designed to treat advanced solid tumors. The drug is part of Innovent’s drive to innovate in the field of immunotherapy.

Dr. Hui Zhou, Senior Vice President at Innovent, highlighted IBI363’s unique molecular design. The drug employs a creative approach that integrates α bias with attenuated β and γ components, significantly enhancing the therapeutic window of IL-2. IBI363 specifically targets tumor-specific T cells expressing both PD-1 and CD25, amplifying their anti-tumor effects. It also exhibits favorable pharmacokinetics and low immunogenicity. Notably, IBI363 has shown promising results in squamous non-small cell lung cancer (NSCLC) treated with immunotherapy and in immunotherapy-naïve mucosal melanoma, which Innovent sees as a potential breakthrough in these areas.

The Phase 1 study of IBI363 involved over 300 subjects with advanced solid tumors, including NSCLC, melanoma, and colorectal cancer. These subjects had undergone multiple prior systemic therapies. IBI363 demonstrated good tolerability and safety at unprecedented dosing levels compared to traditional IL-2 therapy. Common treatment-related adverse events included arthralgia, anemia, and thyroid disorders, with grade 3 immune-related adverse events occurring in 10.4% of subjects. No new safety signals were detected.

In terms of efficacy, 300 subjects receiving IBI363 at doses of 0.1 mg/kg or higher had post-baseline tumor assessments. Among these, three achieved complete responses, and 49 had partial responses. The overall response rate (ORR) in immunotherapy-treated subjects was 17.6%. Particularly, subjects receiving the highest dose of 3 mg/kg Q3W showed an ORR of 46.7% and a disease control rate (DCR) of 80%.

In NSCLC, IBI363 showed strong efficacy, especially in squamous cell carcinoma, with an ORR of 35.1% and a DCR of 75.7%. For those receiving the 3 mg/kg dose, the ORR was 100% for squamous NSCLC and 33.3% for adenocarcinoma NSCLC, with DCRs of 100% in both subtypes. These results are promising given the high resistance to immune checkpoint inhibitors in NSCLC patients.

In melanoma, IBI363 also showed promising efficacy. Among immunotherapy-treated subjects, the ORR was 29.7%, with a DCR of 73.0%. For immunotherapy-naïve mucosal melanoma subjects, the ORR was 75.0%, and the DCR was 100%.

Given these encouraging results, Innovent plans to continue exploring the potential of IBI363 in treating NSCLC, melanoma, and other tumors. Further data and analyses will be presented in future academic conferences or journals.

Professor Xueli Bai from Zhejiang University emphasized the urgent need for effective treatments for NSCLC, noting that most patients develop resistance to current therapies. IBI363’s combination of PD-1 and IL-2 pathways may help overcome this issue. Similarly, Professor Yu Chen from Fujian Cancer Hospital highlighted the potential of IBI363 in treating melanoma, particularly mucosal melanoma, which is typically resistant to immunotherapy.

IBI363 represents a significant step forward in cancer treatment, combining PD-1 inhibition with IL-2 activation to enhance the immune response against tumors. Innovent continues to pursue clinical studies across multiple regions to validate the efficacy and safety of this promising therapeutic agent.