On June 4, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the research data on the treatment of relapsed or refractory extranodal NK/T cell lymphoma (ORIENT-4) by sintilimab, the anti-PD-1 antibody that co-developed with Eli Lilly and Company, was presented in an oral session at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) [Abstract #7504; Tuesday, June 4, 10:57 AM -11:09 AM CDT] (Press release, Innovent Biologics, JUN 4, 2019, View Source [SID1234536886]). ORIENT-4 is the first clinical study of PD-1 antibody from China that was orally presented at ASCO (Free ASCO Whitepaper).

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As the top and most influential international oncology conference, ASCO (Free ASCO Whitepaper) Annual Meeting provides the most important platform for publishing and discussing cutting edge clinical studies. Under the theme "Caring for Every Patient, Learning from Every Patient," 2019 ASCO (Free ASCO Whitepaper) Annual Meeting has attracted numerous top oncologists, scholars, staff from regulatory and patient organizations to share the latest updates and achievements in clinical oncology, with the ultimate goal to help deliver more promising medicines and treatment options to cancer patients.

It is worth noting that more and more Chinese companies choose to participate and disclose their programs in ASCO (Free ASCO Whitepaper), showcasing the importance of emerging Chinese biotech industry. As a leading Chinese biotech company, Innovent will provide key result update of several clinical studies at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting. The results on the treatment of relapsed or refractory extranodal NK/T cell lymphoma (ORIENT-4) with sintilimab will be presented in an oral session by Professor Jianyong Li, Director of Department of Hematology of Jiangsu Province Hospital.

ORIENT-4, the first data released globally for prospective phase II clinical study of PD-1 monoclonal antibody for the treatment of r/r ENKTL, evaluates the efficacy and safety of sintilimab as monotherapy in the treatment of patients with r/r ENKTL.

Patients receive 200 mg sintilimab every 3 weeks until disease progression. Treatment beyond disease progression is allowed. This study includes 28 patients with r/r ENKTL who have progressed after receiving an average of 3 conventional treatments. The primary endpoint is objective response rate (ORR) per LUGANO2014 criteria.

According to the predefined analysis, 19 patients achieved objective response for an ORR of 67.9%, disease control rate (DCR) of 85.7% and 1-year overall survival (OS) rate was 82.1%. (The data cutoff was February 2, 2019 with the median follow-up time of 15.4 months; at which time, 19 patients were still on treatment.)

Extranodal NK/T cell lymphoma is an aggressive malignancy and accounts for more than 20% of the peripheral T-cell lymphoma in Asia. Currently, patients with relapse or refractory disease have few treatment options and poor prognosis. According to historical data, the overall survival is about 6 months, reflecting high unmet medical needs.

Biomedtracker and Datamonitor HealthCare, the two major clinical assessments companies certified by ASCO (Free ASCO Whitepaper), have commented on the results of ORIENT-4, "With 82.1% of patients still alive at one year, these are impressive results for an anti-PD1 antibody in a setting, relapsed/refractory extranodal NK/T cell lymphoma (ENKTL), with few options and where the historical median overall survival is approximately six months."

The results of the ORIENT-4 study suggests that sintilimab, one of 17 major drugs presented at ASCO (Free ASCO Whitepaper) Annual Meeting and also the only drug developed outside U.S. and commented by Biomedtracker and Datamonitor Healthcare, may provide efficacy with an acceptable safety profile for the treatment of r/r ENKTL.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is also conducting clinical studies of sintilimab injection in the United States. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL) and has been included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. There are currently more than twenty clinical studies using sintilimab injection, including eight registration studies that evaluate the efficacy of sintilimab injection in other solid tumors.