First Patient Dosed in a Phase III Trial of Anti-PD-1 Antibody Sintilimab as First-line Treatment for Patients with Advanced Squamous Non-Small Cell Lung Cancer

SUZHOU, China, Sept. 29, 2018 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent), a world-class China-based biopharmaceutical company that develops high quality drugs, announced today that the first patient has been dosed in a phase III clinical trial (ORIENT-12) studying sintilimab, a fully human anti-PD-1 monoclonal antibody (IBI-308), as first-line treatment for patients with previously untreated squamous non-small cell lung cancer (NSCLC).

The ORIENT-12 study is a randomized, double-blinded trial conducted in China to evaluate the efficacy and safety of sintilimab or placebo combined with gemcitabine and platinum-based chemotherapy for first-line treatment of advanced or recurrent squamous NSCLC. The phase III study will enroll 348 patients. The study follows on the phase Ib study cohort E that evaluated sintilimab in combination with gemcitabine and cisplatin for first-line treatment of advanced squamous NSCLC. The detailed results of the study will be published in the recent academic conference.

"Advanced squamous non-small cell lung cancer is not suitable for the application of targeted drugs due to the lack of driver genes, and is not suitable for anti-angiogenic drugs. Immunological checkpoint inhibitors bring new hope to patients with squamous NSCLC. Based on the good efficacy and safety of the previous trials, we hope to validate the therapeutic value of the regimen of sintilimab in combination with chemotherapy in the phase III trial of ORIENT-12," said Professor Caicun Zhou, from the Shanghai Pulmonary Hospital.

"Lung cancer is the most common malignant tumor in China with the highest morbidity and mortality. The development of advanced squamous NSCLC related therapeutic drugs has been stagnant, and there is a huge unmet clinical need. Based on the encouraging efficacy we observed in our phase Ib study of the first-line treatment of advanced squamous NSCLC with sintilimab combined to chemotherapy, we decided to conduct the ORIENT-12 study. The study was the first phase III study in the world to evaluate anti-PD-1 mAb combined with gemcitabine and platinum regimens in the treatment of advanced squamous NSCLC. I hope that the clinical research of sintilimab in this field will be carried out smoothly, so that more cancer patients and families can benefit from the therapy as soon as possible," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent.

About ORIENT-12 Study

The ORIENT-12 study is a randomized, double-blinded, multicenter, phase III study of a combination of sintilimab or placebo with gemcitabine plus platinum-based chemotherapy for first-line treatment of advanced or recurrent squamous non-small cell lung cancer in China. Patients will be treated with a combination of sintilimab or placebo and gemcitabine plus platinum-based chemotherapy (cisplatin or carboplatin) for 4 cycles, followed by maintenance therapy with either sintilimab or placebo until disease progression. The control group is allowed to crossover to the sintilimab treatment. The participants will be randomized 1:1 to the experimental group or control group. The study will enroll 348 patients.

PFS, the primary end point, will be assessed by an Independent Radiologic Review Commitment (IRRC) based on response evaluation using the RECIST 1.1 criteria. 

About Advanced or Recurrent Squamous Non-Small Cell Lung Cancer (NSCLC)

Lung cancer is the world's major malignant tumor with the highest morbidity and mortality. NSCLC accounts for approximately 80% to 85% of all lung cancer cases, and approximately 70% of NSCLC patients at the time of diagnosis are locally advanced or metastatic diseases that are not suitable for surgical resection, and even after undergoing radical surgery for stage I-III patients, about 30-60% of NSCLC patients will experience recurrence or distant metastasis. Among all new cases of NSCLC, squamous cell carcinoma accounts for about 30%. The development of squamous cell carcinoma treatment has been stagnant due to its unique epidemiology, histopathology and molecular characteristics. At present, the first-line regimen for patients with advanced squamous NSCLC is still platinum-based chemotherapy, but the response rate of first-line chemotherapy is about 30%, PFS is about 5.5 months, and OS is about 10.8 months. There are huge unmet medical needs.

About Sintilimab
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.

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. 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.