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Innovent, Eli Lilly announce final clinical results and biomarker analysis of phase Ib study of Tyvyt plus bevacizumab biosimilar injection for advanced HCC at ASCO GI symposium

San Francisco
Monday, January 24, 2022, 10:00 Hrs  [IST]

Innovent Biologics, Inc., a world-class biopharmaceutical company, jointly announced with Eli Lilly and Company the final clinical outcome and biomarker analysis of the open label, phase Ib study (NCT04072679) of sintilimab plus bevacizumab biosimilar injection for advanced hepatocellular carcinoma at the 2022 ASCO Gastrointestinal Cancers Symposium.

The study, which was conducted in China, evaluated the treatment of sintilimab plus bevacizumab biosimilar injection for patients with local advanced or metastatic HCC with or without previous systemic treatment or systemic treatment failure. The phase Ib study included dose escalation and dose expansion stages. In the dose escalation stage, patients were randomly assigned to receive sintilimab 200mg plus bevacizumab biosimilar 7.5 mg/kg (low-dose group) or 15 mg/kg (high-dose group). In the dose expansion stage safety and efficacy were assessed for each dose group. A total of fifty patients were enrolled in final analysis, with 29 patients administered bevacizumab biosimilar 7.5 mg/kg and 21 patients 15 mg/kg. The safety profile was consistent with that observed in previously reported studies of sintilimab and bevacizumab biosimilar, without new or unexpected safety signals. The most common treatment-related adverse events (TRAE) were as hypertension (32%), proteinuria (26%) and fever (26%). The incidence of grade = 3 adverse events in the high-dose group was 28.6%, while 13.8% in the low-dose group.

The overall response rate (ORR) was 34% (17/50) and ORRs for the low-dose and high-dose groups were 31% and 38%, respectively. The disease control rate (DCR) was 78% (39/50). Median progression-free survival (PFS) was 10.5 months (95%CI, 8.4-12.7) and median overall survival (OS) was 20.2 months (95%CI, 16.1 -24.3). Further biomarker analysis showed that patients with a high level of CD137 = 31.8 pg/mL have longer PFS (mPFS:14.2 vs. 4.1months, p=0.001) and OS (mOS: NR vs.15.6months, p=0.023). In addition, the Tumour immune Microenvironment(TiME)analysis demonstrated that the high density of M1 macrophages (CD68+, CD163-) in stroma was related to higher efficacy (p=0.033), longer PFS (p=0. 024) and OS (p =0.046).

Professor Zhou Aiping from the Cancer Hospital of the Chinese Academy of Medical Sciences stated: "This study not only showed the safety and efficacy data for sintilimab in combination with different doses of bevacizumab, but also identified biomarkers that could predict the efficacy of the combined treatment regimen for hepatocellular carcinoma, which lays the groundwork for more individualized treatment."

Dr. Zhou Hui, senior vice president of Innovent Biologics, stated: "Sintilimab plus bevacizumab biosimilar was approved for advanced hepatocellular carcinoma by National Medical Products Administration (NMPA) and successfully included in the National Reimbursement Drug List (NRDL) in 2021. This study showed the clinical data of sintilimab in combination with two different doses of bevacizumab biosimilar, potentially offering more treatment options for physicians. Meanwhile, the exploration of biomarkers for predicting hepatocellular carcinoma immunotherapy will contribute to better treatment options and represent a step towards precise and individualized treatment."

Dr. Li WANG, senior vice president of Lilly China and Head of Lilly China Drug Development and Medical Affairs commented that: "Lilly and Innovent are committed to bringing innovative oncology medicines with global quality to serve patients in China.  The clinical outcome and biomarker analysis result in this phase Ib study of sintilimab plus bevacizumab biosimilar injection for advanced hepatocellular carcinoma provides more solid basis for individualized and precise treatment.  The advancement of HCC treatment may contribute to the government's goal of increasing the overall 5-year cancer survival rate by 15% by 2030, and also supports accelerating the implementation of the 'Health China 2030' initiative. In the future, we will continue to strengthen cooperation with Innovent to endeavour to bring additional treatment options to patients."

NCT04072679 study is a phase 1b study assessing the safety, tolerability and anti-tumour activity of sintilimab in combination with bevacizumab biosimilar in subjects with local advanced or metastatic HCC with or without previous systemic treatment or systemic treatment failure in China. The study has two stages, the first is a dose escalation stage and the second is a dose expansion stage. In the dose escalation stage, subjects will receive either 7.5 mg/kg (low-dose group) or 15 mg/kg (high-dose group) of bevacizumab biosimilar (IBI305) in combination with a fixed dose of 200 mg of sintilimab, respectively, and then entered into the dose expansion stage.

Sintilimab, marketed as Tyvyt (sintilimab injection) in China, is an innovative PD-1 inhibitor with global quality standards jointly developed by Innovent and Eli Lilly and Company. Sintilimab is an immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies of sintilimab worldwide, to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials.


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