On June 2, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the study results for efficacy and safety of IBI305 (biosimilar of bevacizumab) compared with bevacizumab in advanced, first-line, non-squamous NSCLC patients (NCT02954172) were presented by poster at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) [Abstract #9095; Sunday, June 2, 8:00 AM – 11:00 AM CDT] (Press release, Innovent Biologics, JUN 2, 2019, View Source [SID1234536783]).

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As the top and most influential international oncology conference, ASCO (Free ASCO Whitepaper) Annual Meeting provides the most important platform for publishing and discussing cutting edge clinical studies. Under the theme "Caring for Every Patient, Learning from Every Patient", 2019 ASCO (Free ASCO Whitepaper) Annual Meeting has attracted numerous top oncologists, scholars, staff from regulatory and patient organizations to share the latest updates and achievements in clinical oncology, with the ultimate goal to help deliver more promising medicines and treatment options to cancer patients.

It is worth noting that more and more Chinese companies choose to participate and disclose their programs in ASCO (Free ASCO Whitepaper), showcasing the importance of emerging Chinese biotech industry. As a leading Chinese biotech company, Innovent will provide key result update of several clinical studies at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting. The results on the treatment of relapsed or refractory extranodal NK/T cell lymphoma (ORIENT-4) with sintilimab will be presented in an oral session, and key data from several other clinical studies will be presented by posters and other sessions.

IBI305 is a recombinant humanized anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody developed by Innovent for the treatment of non-small cell lung cancer (NSCLC), colorectal cancer and other malignant tumors. Bevacizumab (marketed under the trade name Avastin in China) has been approved globally for the treatment of multiple types of malignant tumors including NSCLC and has a favorable safety and efficacy profile. In 2012, bevacizumab was approved in China. Despite the huge demand for effective cancer therapies, the adoption rate of bevacizumab is relatively low due to low affordability.

NCT02954172 study, led by Professor Li Zhang from Sun Yat-sen University Affiliated Cancer Hospital, is a multicenter, randomized, double-blind, parallel, active-controlled, Phase III study in China, evaluating the efficacy and safety of IBI305 (biosimilar product candidate of bevacizumab) compared with bevacizumab in advanced non-squamous NSCLC patients as first-line treatment with ORR as the primary endpoint.

Among 450 recruited patients in the NCT02954172 study, there are 224 patients in IBI305 cohort and 226 patients in bevacizumab cohort.

The ORRs, evaluated by the Independent Radiological Review Committee (IRRC) in the full analysis set (FAS), were 44.3% (98/221) for IBI305 and 46.4% (102/220) for bevacizumab; the relative risk (RR) for ORR was 0.95 (90% CI: 0.803, 1.135).
The median progression free survival (PFS) was 7.9 months for IBI305 and 7.8 months for bevacizumab and duration of response (DoR) was also similar in both arms.
Treatment-emergent adverse events (TEAEs) were well balanced between treatment arms and consistent with the known adverse event profile of reference bevacizumab.
Based the outcome of the study, the new drug application (NDA) of IBI305 was accepted by the NMPA in January 2019 and has been granted priority review status.

Innovent intends to introduce a more affordable, high-quality biosimilar of bevacizumab to reach more patients in China and to further relieve their disease burden, benefiting more patients and their families.

About IBI305 (bevacizumab biosimilar)

IBI305 is a biosimilar product candidate of bevacizumab and a recombinant humanized anti-VEGF monoclonal antibody for injection. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. Bevacizumab produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. The new drug application (NDA) of IBI305 was accepted by the NMPA on January 29, 2019 and has been granted with priority review status.