On December 8, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, reported that updated clinical data of IBI110 (anti-LAG-3 monoclonal antibody) in advanced squamous non-small cell lung cancer (sqNSCLC) is presented at the 2022 European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO), held Dec 7-9, 2022 (Press release, Innovent Biologics, DEC 8, 2022, View Source [SID1234624967]).

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Efficacy and safety of IBI110 (anti-LAG-3 mAb) in combination with Sintilimab (anti-PD-1 mAb) in Advanced Squamous Non-small Cell Lung Cancer (sqNSCLC): Updated Results from a Phase Ib Study

Poster #: 86P

IBI110 is an IgG4κ recombinant human anti-LAG-3 monoclonal antibody developed by Innovent Biologics. The Phase Ib study aims to evaluate the efficacy and safety of IBI110 in combination with sintilimab and chemotherapy (paclitaxel plus carboplatin) as first-line therapy for advanced sqNSCLC.

20 treatment naïve sqNSCLC patients received IBI110 (200 mg, Q3W) combined with sintilimab and chemotherapy and received at least 1 post-baseline tumor assessment. As of the data cutoff date of Oct 25, 2022, median follow-up time was 12.0 (95% CI, 11.9 -13.1) months, 16 patients achieved partial response (PR), the objective response rate (ORR) was 80%; the 12-month progression free survival (PFS) rate was 60.0% (95% CI, 35.7-77.6), the median PFS was not reached; the 12-month overall survival (OS) rate was 85.0% (95% CI, 60.4-94.9) .
For safety results, the most common treatment related adverse events (TRAEs) ≥ grade 3 were decreased neutrophil count (30.0%) and decreased white blood cell count (20.0%). Immune-related AEs (irAEs) occurred in 14 patients, in which only 4 patients experienced irAE ≥ grade 3. No treatment-related deaths occurred.
IBI110 combined with sintilimab and chemotherapy in advanced sqNSCLC continues to show robust anti-tumor activity and favorable safety. The study is ongoing with the clinical data in squamous NSCLC continuing to mature and will be disclosed in the future academic conference/journals.
Professor Caicun Zhou, Shanghai Pulmonary Hospital, stated: "Lung cancer is the most commonly diagnosed cancer and the leading cause of cancer death worldwide, of which non-small cell lung cancer accounts for about 80%1. In recent years, PD-1/PD-L1 inhibitors have shown promising efficacy in non-small cell lung cancer2. However, persistent response to immune checkpoint inhibitor monotherapy remains a challenge in clinical practice. IBI110 plus sintilimab indicate promising antitumor activity and a manageable safety profile in untreated squamous non-small cell lung cancer patients. In the current 20 patients, the ORR reached 80% and the 12-month PFS rate was 60%, which warrants further investigation into the safety and efficacy of IBI110 combination therapy in this indication."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present our clinical development updates at the 2022 ESMO (Free ESMO Whitepaper)-IO Meeting. IBI110 in combination with sintilimab demonstrated encouraging efficacy and safety data in sqNSCLC. We will continue to provide updates on the PoC data for IBI110 and plan to initiate pivotal clinical studies. As immunotherapy moves into the next era, we are actively advancing the development of next-generation immune checkpoint inhibitors, among which IBI110 represents a high-potential LAG-3 asset, which we hope will benefit patients in need soon."

To learn more about Innovent’s R&D updates and activities, please visit View Source

About IBI110

IBI110 is an IgG4κ recombinant human anti-LAG-3 monoclonal antibody independently developed by Innovent Biologics. Based on the mechanism of action and preclinical data of IBI110, it is assumed that IBI110 can inhibit the immune checkpoint signaling to achieve anti-tumor effect, which may further improve the efficacy of immunotherapy, overcome the primary drug resistance, and overcome the drug resistance after anti-PD-1 /PD-L1 monoclonal antibody treatment3. Based on the urgent clinical needs, Innovent has carried out clinical studies to explore PK/PD characteristics of IBI110 single agent and combined with sintilimab in humans as well as its efficacy and safety in various advanced tumors. This clinical trial (NCT04085185) is the first in human clinical study of IBI110.