Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announced that the results of the Phase Ia/Ib study of IBI110 were released today in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2021 (Abstract #2589).
The phase 1 study of IBI110 is a dose-escalation trial evaluating IBI110, an anti-LAG-3 monoclonal antibody, as a single agent and in combination with sintilimab in patients with advanced solid tumors refractory to standard of care therapy. The study is comprised of Phase Ia, an IBI110 single-drug dose-escalation phase, and Phase Ib, the dose-escalation phase of IBI110 in combination with sintilimab (200mg). At disease progression, cross over from IBI110 monotherapy to combo (IBI110+ sintlilimab) was allowed at the investigators' discretion. At data cutoff (February 9, 2021), 40 patients were enrolled and received treatment. 22 subjects were assigned in dose groups of 7 (0.01mg/kg~20mg/kg) in Phase Ia, the prespecified dose escalation had been completed and no dose-limited toxicity (DLT) was observed. No adverse event (AE) led to discontinuation of IBI110 or sintilimab and no treatment-related death was reported. In terms of efficacy, a subject with advanced ovarian cancer who progressed on multiple prior systemic therapies achieved partial response after IBI110 monotherapy treatment and was still in the study for more than 6 months. 18 subjects were assigned in dose groups of 5 (0.3mg/kg~5mg/kg) in Phase Ib of IBI110 in combination with sintilimab, the prespecified dose escalation had been completed and no dose-limited toxicity (DLT), adverse events leading to discontinuation or death was observed. At data cutoff (April 26, 2021), three subjects had achieved partial response with an objective response rate of 16.7% (3/18) in phase 1b, demonstrating a synergistic anti-tumor activity of IBI110 and sintilimab.
"The efficacy signal and safety profile we see with IBI110 in this study is exciting," said Dr. Hui Zhou, Senior Vice President of Clinical Development, Innovent Biologics. "The single-drug efficacy demonstrated in the trial suggested a huge anti-tumor potential of this target. As we move ahead with the study, we look forward to greater clinical benefits of IBI110 in combination with sintilimab in patients in this trial. We are committed to innovation and relentless pursuit of breakthroughs for cancer patients. Aside from IBI110, we are also initiating phase 1 clinical trial on IBI323, a LAG-3/PD-L1 bispecific antibody, to fully investigate therapeutic value of LAG-3. "
Professor Caicun Zhou from Shanghai Pulmonary Hospital said: "IBI110's good safety and preliminary efficacy data support the further exploration of this molecule in a variety of tumor types, including non-small cell lung cancer, small cell lung cancer, melanoma, etc. LAG-3 is the third validated immune-related target after PD-1 and CTLA-4. We look forward to seeing more positive results from the upcoming trials of IBI110."
About the Study
This study is a phase Ia/Ib open label, dose escalation and expansion study to evaluate the safety, tolerability and efficacy of IBI110, an anti-LAG-3 monoclonal antibody, as a single agent and in combination with sintilimab in advanced solid tumors. The study follows a classic 3+3 design. Patients received escalating doses of IBI110 once every 3 weeks in phase Ia and escalating doses of IBI110 in combination with TYVYT® (sintilimab injection) 200 mg once every 3 weeks in phase Ib until disease progression, unacceptable toxicity, or withdrawal of consent.
Primary objectives of the trial were to evaluate the safety, tolerability and the antitumor activity of IBI110 monotherapy and in combination with sintilimab.
About LAG-3
Lymphocyte activation gene-3 (LAG-3) (CD223) is a novel 498-amino acid type I transmembrane protein identified on activated human NK and T-cell lines. LAG-3 (CD223) is a potential cancer immunotherapeutic target due to its negative regulatory role on T cells and its capacity, in combination with PD-1, to mediate a state of exhaustion.
About TYVYT® (sintilimab Injection)
TYVYT® (sintilimab injection) is an innovative PD-1 inhibitor with global quality standards jointly developed...
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