SUZHOU, China, Sept. 20, 2018 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, today presented clinical research data on cohort C at the 2018 Annual Meeting of Chinese Society of Clinical Oncology (CSCO). The study is a phase Ib clinical trial (NCT02937116) in which NSCLC patients with disease progression failed from prior therapy were treated with sintilimab (a fully human anti-programmed cell death 1 monoclonal antibody).
37 patients who had progressed on at least one line of prior therapies were enrolled, and 34 patients have had at least one radiological assessment. Patients receiving sintilimab monotherapy enjoyed an objective response rate (ORR) of 17.6% based on irRECIST criteria, a median progression free survival (PFS) of 2.8 months, medium overall survival of 13.8 months and as of the medium follow-up time of 8.4 months.
The incidence and severity of adverse events were comparable with other anti-PD1 products. The relationship between tumor mutation burden (TMB) and efficacy of sintilimab was also explored by analyzing TMB level in 25 patients. Among 6 patients whose TMB level was high (>12 mutations/Mb), ORR was 50%, and disease control rate (DCR) was 100%.
ORIENT-3, an open-label, multi-center, randomized Phase III clinical trial, which compares the efficacy and safety of sintilimab to docetaxel in patients with advanced or metastatic squamous NSCLC who had disease progression on first-line platinum-based therapy is ongoing in China.
"We have seen good efficacy and safety in several clinical trials on lung cancer carried out by Innovent. As a physician, it is our relentless pursuit to explore safer and more effective treatments to help the patient with malignant tumors to obtain a healthier and longer life. We have great expectations for sintilimab and hope to see more positive result in the future clinical trials, which will benefit more patients and families soon," said Professor Li Zhang, from the Sun Yat-Sen University Cancer Center.
"Lung cancer has the highest morbidity and mortality among malignant tumors in China, we are delighted to witness the efficacy and safety profile of sintilimab for standard treatment failed NSCLC," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent, "At present, the phase III study of the second line squamous NSCLC is progressing smoothly, and we hope to provide more treatment options for lung cancer patients in the future."
About Advanced or Recurrent Non-squamous Non-Small Cell Lung Cancer
Lung cancer has the highest incidence and mortality among all malignancies in China. NSCLC accounts for about 80% to 85% of all lung cancer cases, and at diagnosis about 70% of NSCLC patients are locally advanced or metastatic, with a 5 year overall survival rate less than 20%. Even patients with early-stage NSCLC who undergo successful surgery are at high risk of recurrence and metastasis, resulting in a 5 year overall survival rate of 50%. In China, squamous NSCLC represents 30% of total NSCLC. Patients who have failed standard treatment have high unmet medical needs.
Sintilimab is a fully human anti-PD-1 antibody. It binds to the PD-1 receptor on T cells, blocking the PD-L1 ligand from interacting with PD-1 to help restore T-cell response and immune response, thus destroying the tumor cells. Sintilimab is an anti-PD-1 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company in China. National Medical Products Administration (NMPA, formerly known as CFDA) accepted the New Drug Application (NDA) submitted by Innovent for sintilimab on April 16, 2018, and granted it priority review status on April 23, 2018. The indication for the first new drug application is relapsed/refractory classical Hodgkin's Lymphoma.
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. Since its establishment from 2011, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities, and a pipeline of innovative and commercially promising monoclonal antibodies and other biologics in the fields of oncology, ophthalmology, autoimmune and metabolic diseases. Innovent has built up a pipeline of 17 antibody drug candidates, with four core products in late-stage clinical development in China and one that has a New Drug Application (NDA) accepted by the NMPA with priority review status.
Innovent has a highly talented international team, including many expert returnees with experience in innovative biopharmaceutical drug discovery, development, production and commercialization. The company has also entered into various key strategic alliances with Eli Lilly and Company, Adimab, and other biopharmaceutical companies. Innovent has raised 580 million USD in private financing from numerous world-renowned VC or PE firms, including Eight Roads and F-Prime Capital (which form part of the proprietary investment business of Fidelity), Lilly Asia Ventures, Capital Group, Legend Capital, Temasek, Rock Springs Capital, Cormorant Private Healthcare, Hillhouse Capital, China Life, Ally Bridge, Taikang Insurance Group, and State Development & Investment Corporation.
About the partnership between Innovent Biologics and Eli Lilly and Company
Eli Lilly and Company (Lilly) and Innovent Biologics (Innovent) in March 2015 announced one of the largest biotech drug development collaborations in China to date between a multi-national and domestic company. Under the terms of the agreement, Lilly and Innovent shall collaborate to provide support to the development and potential commercialization of at least three cancer treatments over the next decade. In October 2015, they announced an expansion of their drug development collaboration. These collaborations represent that Innovent has struck one of the most comprehensive strategic partnerships of any Chinese company with a multinational partner in terms of the scope and breadth ranging from discovery to commercialization and involving up to six therapeutic antibodies for cancers.
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SOURCE Innovent Biologics, Inc.