SUZHOU, China, Oct. 14, 2018 /PRNewswire/ — The combination therapy of novel programmed death 1 (PD-1) antibody IBI308 (sintilimab, Innovent Biologics) with biosimilar bevacizumab antibody IBI305 (Innovent Biologics) has received the investigational new drug (IND) application for clinical development approval by the National Medical Products Administration (NMPA, formerly known as CFDA) in China.

Innovent Biologics announced clinical trials with the combination therapy in non-small cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC) to assess the safety and efficacy. Innovent Biologics has signed a partnerhip agreement from discovery to commercialisation with Eli Lilly and Company.

Previously, Innovent completed the bioequivalence studies in healthy volunteers as well as a randomised, double-blind, multicenter, Phase III study in NSCLC comparing IBI305 with Avastin.

“Recent studies have shown there is a strong relationship between tumour-induced angiogenesis driven by vascular endothelial growth factor A (VEGFA) and angiopoietin-2 (ANGPT2) and tumour-induced immunosuppression driven by PD-1/PD-L1. Abnormal tumour-induced angiogenesis appears to limit the therapeutic effect of anti-PD-1/PD-L1 antibodies and other immunotherapy drugs.”

Dr. Kerry Blanchard, Chief Scientific Officer of Innovent Biologics.

The rationale for targeting the PD-1 plus VEGF-axis

Several studies have shown benefit for the combination of a PD-1 or PD-L1 antibody and a VEGF antibody.

In lung cancer, the Phase III IMpower150 (NCT02366143) study showed benefit for the combination therapy with PD-1 ligand (PD-L1) inhibitor atezolizumab (Tecentriq®, Roche/Genentech) monoclonal antibody in combination with bevacizumab plus chemotherapy in patients with non-squamous NSCLC harbouring epidermal growth factor receptor (EGFR) mutations after failing an EGFR-tyrosine kinase inhibitor (TKI).

Phase Ib (NCT02715531) evidence in the first-line treatment of liver cancer revealed the combination atezolizumab plus bevacizumab to be safe and effective; the objective response rate was 65%.

“China has the highest burden of cancer patients of all countries in the world. Lung cancer and liver cancer account for about one third of all incident cases of cancers in China.”

Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent Biologics

About Non-Small Cell Lung Cancer

Lung cancer is the most common malignancy in China, ranking first in both morbidity (781,000 new cases annually) and mortality (626,000 deaths annually). Approximately 80- 85% of all lung cancer is of NSCLC histology and around 40% of NSCLC-patients harbour EGFR-mutations. 

Therefore, large groups of NSCLC patients in China receive front-line treatment with an EGFR-TKI, such as gefitinib, erlotinib, or icotinib. In the second-line treatment, subsets of patients may receive treatment with osimertinib based on the mutation status. Patients without mutations amenable to osimertinib or for those who fail the second-line TKI, the standard of care treatment is platinum-doublet chemotherapy.

About Hepatocellular Carcinoma (HCC)

Liver cancer ranks second after lung cancer for cancer-related deaths; the morbidity of liver cancer is about 365,000 new cases annually, and the mortality numbers are 319,000 deaths annually. The vast majority of patients have locally advanced or metastatic disease upon diagnosis and are thus ineligible for treatment with curative intent. Liver cancer patients often receive first-line treatment with sorafenib (Nexavar®, Bayer) or lenvatinib (Lenvima®, Eisai). In the second-line, physicians and patients have a choice of nivolumab (Opdivo®, Bristol-Myers Squibb), regorafenib (Stivarga®, Bayer), ramucirumab (Cyramza®, Eli Lilly), or cabozantinib (Cabometyx®/Cometriq®, Exelixis).

References

Innovent Biologics. (2018, October 15) Innovent Receives IND Approval to Initiate Clinical Trials in China with Sintilimab in Combination with its Biosimilar to Bevacizumab [Press Release]. Retrieved from https://www.prnewswire.com/news-releases/innovent-receives-ind-approval-to-initiate-clinical-trials-in-china-with-sintilimab-in-combination-with-its-biosimilar-to-bevacizumab-300730655.html