Innovent Biologics, Inc. announed that the results of efficacy and safety of IBI305 (bevacizumab biosimilar) versus bevacizumab, both in combination with paclitaxel/carboplatin for the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients in a randomized, double-blind Phase III clinical trial (CTR20160848), were presented in an oral session at the 22nd Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) [Thursday, September 19, 11:25 AM -11:30 AM BJT].
SUZHOU, China, Sept. 19, 2019 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, metabolic and other major diseases, announced today that the results of efficacy and safety of IBI305 (bevacizumab biosimilar) versus bevacizumab, both in combination with paclitaxel/carboplatin for the first-line treatment of advanced non-small cell lung cancer (NSCLC) patients in a randomized, double-blind Phase III clinical trial (CTR20160848), were presented in an oral session at the 22nd Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) [Thursday, September 19, 11:25 AM -11:30 AM BJT].
450 patients were enrolled and randomized into IBI305 group (n = 224) and reference bevacizumab (RBv) group (n = 226). By the cut-off date of March 31, 2019, the IRRC-assessed overall response rates (ORR) were 47.1% and 46.8% in IBI305 and RBv in full analysis set, respectively. The ORR ratio (IBI305/RBv) was 1.01 (90% CI: 0.846, 1.181) within the predefined equivalence margin (0.75, 1.33). By the cut-off date of May 22, 2019, the results showed that the investigator-evaluated median progression-free survival (PFS) in IBI305 and RBv groups were 7.3 months and 7.5 months, respectively, with no statistical difference (p=0.893).
“Lung cancer is the highest incidence cancer in China, and bevacizumab is an important treatment for non-squamous non-small cell lung cancer patients. It shows desirable results of the randomized, double-blind Phase 3 study comparing the efficacy and safety of IBI305 and bevacizumab combined with paclitaxel/carboplatin for the first-line treatment of advanced or metastatic non-squamous cell lung cancer. We hope this drug can be launched on the market soon and provide more treatment options to patients,” said Professor Li Zhang, Cancer Prevention and Treatment Center, Sun Yat-sen University.
“Lung cancer is the malignant tumors with the highest morbidity and mortality in China. Currently, we have eight registration trials in progress, four of which are for the treatment of lung cancer. We hope to bring more clinical benefits to patients through our efforts and address the significant unmet medical needs in China,” said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent.
About Advanced Non-squamous Cell Lung Cancer (NSCLC)
Lung cancer is the most common malignant tumor with the highest morbidity and mortality in China. NSCLC accounts for about 80% to 85% of all lung cancer cases. About 70% of NSCLC patients are locally advanced or metastatic diseases that unsuitable for resection at diagnosis. Meanwhile, a considerable proportion of early NSCLC patients who received surgical treatment will have recurrence or distant metastasis, and then will die due to disease progresses. About 70% of NSCLC patients in China are non-squamous NSCLC, and the first-line treatment for the disease has huge unmet medical needs.
About IBI305
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.
About Innovent
Inspired by the spirit of “Start with Integrity, Succeed through Action,” Innovent’s mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of oncology, autoimmunity and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.
Since it was founded, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 21 innovative assets in the fields of oncology, metabolic diseases and other major therapeutic areas. Sixteen have entered into clinical development, four have entered Phase 3 clinical trials, three monoclonal antibodies have their New Drug Application (NDA) under review and three of them have been granted with priority review status, and one, Tyvyt® (sintilimab injection), is now approved for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL).
Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China’s biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients’ lives. For more information, please visit:
www.innoventbio.com.
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Company Codes: HongKong:1801, OTC-PINK:IVBIY
