On June 3, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, reported that the results of extended follow-up on sintilimab, the anti-PD-1 antibody that co-developed with Eli Lilly and Company, for relapsed/refractory classical Hodgkin’s lymphoma (r/r cHL) (ORIENT-1) were presented by poster at the 55th annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) [Abstract #7533; Monday, June 3, 8:00 AM -11:00 AM CDT] (Press release, Innovent Biologics, JUN 3, 2019, View Source [SID1234536843]).
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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, and key data from several other clinical studies will be presented by posters and other sessions.
ORIENT-1, led by Professor Yuan-kai Shi, Associate Dean of the Cancer Hospital of the Chinese Academy of Medical Sciences and Director of the Department of Oncology, is a multicenter, single-arm, Phase II study in China, evaluating the efficacy and safety of sintilimab for the treatment of patients with relapsed/refractory classical Hodgkin’s lymphoma. Currently, ORIENT-1 study has the largest cohort of cHL patients in China with a total of 96 patients involved.
The primary clinical endpoint is objective response rate (ORR) as assessed by an independent radiological review committee (IRRC) according to 2007 IWG criteria. Moreover, complete response rate (CRR) is a secondary endpoint.
As of the data cutoff on 16 Oct 2018, 72.9% of patients were continuing treatment with a median follow-up of 14 months. ORR was 85.4% (82/96, 95% CI: 76.7 ~ 91.8) based on IRRC review. Twenty-eight patients (29.2%) achieved complete response (CR) by PET scan. The median duration of response (DoR) and progression free survival (PFS) have not been reached. Sintilimab showed an acceptable safety profile during the study.
Based on the results of ORIENT-1 study, sintilimab was approved for treating patients with r/r cHL in China.
The extended follow-up shows that the primary endpoint, ORR, has increased to 85.4% and the secondary endpoint, CR by PET scan, has increased to 29.2 %. Innovent intends to continue updating the response and survival rate for patients who have received sintilimab in this clinical trial.
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.