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.
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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