On 22 January 2022, Chinese company Innovent announced the final clinical results from a phase Ib study of sintilimab injection plus bevacizumab biosimilar injection. The results were presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2022.

Sintilimab is a monoclonal antibody treatment used to treat Hodgkin’s disease. It works by targeting PD-1, a protein that can prevent the immune system from killing cancer cells. It was developed jointly by Innovent and Eli Lilly and sold under the brand name Tyvyt.

The latest results relate to the use of sintilimab injection plus biosimilar bevacizumab injection, for the treatment of advanced hepatocellular carcinoma. The study, which was an open label phase Ib study, was conducted in China and evaluated the treatment of sintilimab plus biosimilar bevacizumab injection for 50 patients with hepatocellular carcinoma.

The results showed that the safety profile was consistent with previous studies. The overall response rate for the treatment was 34% and the disease control rate was 78%. Median progression-free survival was 10.5 months and median overall survival was 20.2 months. Biomarker analysis also revealed components associated with efficacy and longer overall and progression-free survival.

Dr Zhou Hui, Senior Vice President of Innovent Biologics, said ‘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, added: ‘The clinical outcome and biomarker analysis result in this phase Ib study of sintilimab plus bevacizumab biosimilar injection for advanced hepatocellular carcinoma provides a more solid basis for individualized and precise treatment. The advancement of [hepatocellular carcinoma] 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 endeavor to bring additional treatment options to patients’.

The NMPA of China accepted the supplemental new drug application for this combination in December 2021. The application was for use together with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung-cancer (nsqNSCLC) who progressed after EGFR-tyrosine kinase inhibitors (TKI) therapy.

The acceptance was based on the results of the ORIENT-31 trial, a randomized, double-blind, multicentre phase III clinical trial. The trial evaluated sintilimab in combination with or without biosimilar bevacizumab and chemotherapy compared to placebo in combination with chemotherapy in patients with (EGFR)-mutated nsqNSCLC who progressed after EGFR-TKI therapy.

Interim analysis of the trial showed a significant improvement in progression-free survival from sintilimab in combination with bevacizumab and chemotherapy compared to placebo combined with chemotherapy. Objective response rate and duration of response were also improved.

Dr Hui Zhou, Senior Vice President of Innovent, commented on the approval: ‘While immunotherapy has been approved for treatment of many malignancies, it has not yet been proven to be sufficiently efficacious for oncogene driven cancers. The acceptance of this sNDA by China’s NMPA represents an important milestone in demonstrating the potential value of sintilimab plus bevacizumab and chemotherapy in patients with EGFR-mutated nsqNSCLC who progressed after EGFR-TKI therapy. We look forward to working with the China regulatory authorities on the sNDA review and we hope to bring the new regimen to patients with EGFR-mutated nsqNSCLC who progressed after EGFR-TKI therapy as quickly as possible.’

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