First Patient Dosed in a Phase III Trial of Anti-PD-1 Antibody as First-line Treatment for Patients with Non-Squamous Non-Small Cell Lung Cancer
SUZHOU, China, Sept. 10, 2018 /PRNewswire/ -- Innovent Biologics (Innovent), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, announced today that the first patient has been dosed in a phase III clinical trial (ORIENT-11) studying sintilimab, a fully human anti-PD-1 monoclonal antibody (IBI308), as first-line treatment for patients with non-squamous non-small cell lung cancer (NSCLC).
ORIENT-11 is a randomized, double-blinded, multicenter, phase III study of sintilimab or placebo combined with pemetrexed (Alimta®) and platinum-based chemotherapy as first-line treatment for advanced or recurrent non-squamous non-small cell lung cancer (ns-NSCLC) in China. Innovent plans to enroll 378 patients in this trial. The study is based on a phase Ib study that assessed the efficacy of sintilimab in combination with pemetrexed and cisplatin as first-line treatment of advanced non-squamous NSCLC. The results of the phase 1b trial will be announced at the 2018 Annual Meeting of Chinese Society of Clinical Oncology (CSCO).
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 Lymphoma.
"Lung cancer has the highest morbidity and mortality among malignant tumors in China. With sintilimab entering phase III clinical trial for lung cancer, we hope to provide more treatment options for lung cancer patients in the future," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.
ORIENT-11 is a randomized, double-blinded, multicenter, phase III study of sintilimab or placebo combined with pemetrexed and platinum-based chemotherapy as first-line treatment to advanced or recurrent non-squamous non-small cell lung cancer (ns-NSCLC) in China. Patients are treated with sintilimab or placebo in combination with pemetrexed/platinum doublet (cisplatin or carboplatin) chemotherapy for four cycles, followed by the maintenance treatment of sintilimab or placebo in combination with pemetrexed until disease progression, intolerable toxicity, withdrawal of consent, death, or other specified events in the protocol (whichever occurs first). Patients with advanced or recurrent ns-NSCLC, who have not received previous systemic anti-tumor therapy, will be randomized and enrolled in experimental and control group in the 2:1 proportion in the study. In total, 378 patients will be enrolled, with 252 patients in the sintilimab group (experimental group) and 126 patients in the placebo group (control group). The primary endpoint of the study is progression free survival (PFS), according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1), and as assessed by an Independent Radiological Review Committee (IRRC).
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. In addition, many patients with early-stage NSCLC eventually die due to disease progression after disease recurrence or distant metastasis, albeit having successful surgery. About 70% of NSCLC patients in China present with non-squamous histology type, of whom 40% have an EGFR mutation. EGFR inhibitors are recommended as first-line treatment for advanced NSCLC patients with EGFR mutations. An ALK re-arrangement occurs in about 3% of patients with ns-NSCLC and ALK inhibitors are recommended for this patients population. The first-line standard treatment for advanced ns-NSCLC patients without EGFR mutations or ALK re-arrangement in China is platinum-based doublet chemotherapy. The unmet medical needs for these patients are high.
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 jointly developed by Innovent Biologics and Eli Lilly and Company in China. It is also the first drug candidate with a NDA submitted to NMPA by 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. 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 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 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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Innovent Biologics, Inc.
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