Innovent Presents Clinical Data of Anti-PD-1 Antibody Sintilimab in Patients with First-line Squamous NSCLC at Asia Conference on Lung Cancer 2018

SUZHOU, China, Nov. 9, 2018 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 1801), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, today presented clinical research data on cohort E from a Phase Ib clinical trial at the International Association for the Study of Lung Cancer (IASLC) Asia Conference on Lung Cancer 2018 (#ACLC18). In this cohort of the Phase Ib clinical trial (NCT02937116), patients with first-line squamous non-small cell lung cancer (sNSCLC) were treated with sintilimab, a fully human anti-programmed cell death 1 (PD-1) monoclonal antibody, in combination with gemcitabine and cisplatin.

The combination demonstrated an objective response rate (ORR) of 64.7% and disease control rate (DCR) of 100.0%, based on data from 17 patients with at least one radiological assessment among a total of 20 patients in this cohort. As of the data analysis cutoff on September 1, 2018, after median follow up of 6.6 months, the data of median duration of response (DOR) and median progression free survival (PFS) were not yet mature, the preliminary results of which were 6.0 months and 6.8 months, respectively. Twelve-month overall survival (OS) was 87.0%. The study shows evidence of anti-tumor efficacy and an acceptable safety profile.

Based on the efficacy and safety profile from this early phase clinical trial, we have initiated ORIENT-12, a randomized, double-blinded, multicenter, phase III study of sintilimab versus placebo, both in combination with gemcitabine and platinum-based chemotherapy as first-line treatment for advanced or recurrent sNSCLC in China. Patient recruitment for this study is currently under way and Innovent plans to enroll 348 patients. The first patient dosing has been accomplished recently.

"Immune checkpoint inhibitor has brought hope to patients suffering from squamous non-small cell lung cancer, who are unfit for either target therapy due to its lack of driving gene mutation, or anti-angiogenic therapy in first line setting," said Professor Kejing Ying from Sir Run Run Shaw Hospital, Zhejiang University School of Medicine. She expressed her great expectation for the result from phase III clinical trial and the approval of sintilimab as first-line treatment for NSCLC.

"Lung cancer has the highest morbidity and mortality among malignant tumors in China. Despite breakthrough in recent years, treatment for squamous lung cancer is still limited, and the effect is unsatisfying," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent, "At present, Innovent has launched phase III clinical study of squamous lung cancer. We hope these clinical trials will benefit squamous lung cancer patients as quickly as possible, bringing patients and their families hope for extended vitality."

About advanced or metastatic squamous non-small cell lung cancer (sNSCLC)

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 about 70% of NSCLC patients have locally advanced or metastatic disease at first diagnosis. In addition, many patients with early-stage NSCLC after undergoing potentially curative surgery eventually die from disease progression after disease recurrence or distant metastasis. Squamous NSCLC (sNSCLC) accounts for about 30% of all NSCLC patients in China. Due to its unique epidemiological, histological and molecular biological character, sNSCLC still lacks effective treatment modality, with platinum-based chemotherapy as the first-line treatment. However, platinum-based chemotherapy only obtains an objective response rate (ORR) of 30%, progression free survival (PFS) of 5.5 months and overall survival (OS) of 10.8 months, which is far from satisfying. The unmet medical needs in this patient population are high.

About ORIENT-12

ORIENT-12 is a randomized, double-blinded, multicenter, phase III study of sintilimab versus placebo, both in combination with gemcitabine and platinum-based chemotherapy as first-line treatment for advanced or recurrent sNSCLC in China. Patient recruitment for this study is currently under way and Innovent plans to enroll 348 patients. The first patient dosing has been accomplished recently.

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, successor to 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 wishes to work with all relevant parties helping the advancement of China's biopharmaceutical industry, so as to improve drug availability to people and address their aspiration for a healthy, happy life.

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.