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 clinical data of IBI939 (anti-TIGIT monoclonal antibody) is presented at the 2022 European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO), Dec 7-9, 2022 (Press release, Innovent Biologics, DEC 8, 2022, View Source [SID1234624969]).

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A Phase Ib Study to Evaluate the Safety, Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients with Previously Untreated Locally Advanced Unresectable or Metastatic PD-L1-Selected NSCLC

Poster #: 77P

IBI939 is a recombinant fully human anti-T-cell immunoreceptor with Ig and ITIM domains (TIGIT) monoclonal antibody developed by Innovent Biologics. This Phase Ib study aimed to evaluate safety, tolerability, and efficacy of combination therapy of IBI939 with sintilimab in patients with previously untreated, locally advanced unresectable or metastatic PD-L1 TPS≥50% NSCLC without sensitizing mutations. As of October 15th, 2022, 42 pts were randomized (2:1) to receive IBI939 plus sintilimab (experimental arm) or sintilimab monotherapy (control arm). The study results were as follows:

Baseline characteristics: in the experimental arm (n=28), median age was 65 and 7 (25%) patients have brain metastasis; in the control arm (n=14), median age was 58 and 1 (7.1%) patient has brain metastasis.
As of the data cutoff date, among 40 efficacy evaluable patients (27 vs. 13). The median follow-up duration was 11.0 mos (95%CI, 9.6-11.3) in experimental arm and 9.8 mos (95%CI, 8.1-10.9) in control arm. Confirmed objective response rate (ORR) was 64.3% vs 57.2% and the disease control rate (DCR) was 85.7% vs 78.6% in experimental arm and control arm, respectively. The median PFS was 11.2 mos (95%CI, 6.7-NA) in experimental arm vs 6.4 mos (95% CI, 1.4-NA) in control arm (HR: 0.55);
For safety results, the incidence of TRAEs was 96.4% vs 71.4% (4 vs 5 pts experienced grade ≥ 3 TRAEs), in experimental arm vs control arm, respectively. Two patients in experimental arm and one patient in control arm experienced TRAE leading to study treatment discontinuation. No grade 5 TRAE happened in experimental arm.
The study is still ongoing; primary efficacy data will be further evaluated and presented in future medical conferences.
Professor Ying Cheng, Jilin Cancer Hospital, stated: "PD-L1 TPS≥50% NSCLC is sensitive to PD-1/PD-L1 inhibitors as first-line systemic therapy indicating promising survival benefits for patients[1]. IBI939 plus sintilimab bring encouraging efficacy to patients and present a manageable safety profile in the Phase Ib study. The study is still ongoing, and we look forward to the follow-up results of positive efficacy data in the future."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present the clinical development updates of IBI939 at the 2022 ESMO (Free ESMO Whitepaper)-IO Meeting. IBI939, in combination with sintilimab, demonstrated encouraging efficacy and safety data in the Phase Ib clinical study. PFS benefit and tolerable safety profiles were observed. We will continue to provide updates on the PoC data readout for IBI939 in treatment areas such as lung cancer and plan to initiate subsequent pivotal clinical studies. As immunotherapy moves into the next era, we continue to focus on developing and commercializing high-quality biopharmaceuticals that are affordable to ordinary people."

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

About IBI939

IBI939 is an IgG4κ recombinant human anti-TIGIT monoclonal antibody developed by Innovent Biologics. Targeting TIGIT on T cells and NK cell membranes in the tumor microenvironment, this drug candidate can prevent the binding of CD155 overexpressed on the cancer cell membrane to TIGIT, thereby restoring the activation of cytotoxic T cells and NK cells, and exerting tumor killing effects[2]. TIGIT and PD-1 are both immunosuppressive checkpoint receptors. Inhibition of TIGIT and PD-1 can synergistically promote immune cells to kill tumors and enhance anti-tumor immune response.