2018-09-26| Trials & Approvals

Innovent reports clinical trial results of its anti-PD-1 monoclonal antibody

by Rajaneesh K. Gopinath
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Sintilimab, the first drug submitted for New Drug Application (NDA) by Innovent Biologics is making quick strides as a first-line of treatment for patients with non-squamous non-small cell lung cancer.

Sintilimab is a fully human IgG4 anti-PD-1 monoclonal antibody generated from yeast display technology. It binds to the programmed cell death 1 (PD-1) receptor on T cells thereby blocking the interaction of PD-L1 ligand and PD-1. This helps restore the T-cell immune response which destroys tumor cells. Developed in collaboration with Eli Lilly, Sintilimab has been received by over 400 human subjects in clinical studies for both solid and blood-borne cancers for safety and efficacy evaluation (1).

At the 21st Annual Meeting of Chinese Society of Clinical Oncology (CSCO) organized in Xiamen last week, Innovent Biologics Inc. presented the Phase Ib trial data from its neuroendocrine tumor (NET) and non-small cell lung cancer (NSCLC) cohorts. Dubbed as one of the largest clinical studies of anti-PD-1 antibody for the treatment of NET, the objective response rate (ORR) was found to be 22.7%, based on the data from 22 patients with at least one radiological assessment. Furthermore, in 19 patients with poorly differentiated neuroendocrine carcinoma, the ORR was 26.3%. As per the calculations made until the cutoff date on June 28, 2018, the median duration of response (DOR) was found to be 5.8 months, while the progression free survival (PFS) was 2.2 months. The median overall survival had not been reached and the drug safety profile was consistent with that of trials involving other tumors (2).

Earlier this year, Innovent published the preliminary result of its multicenter, single-arm, phase 2 registrational study (ORIENT-1 trial) of Sintilimab studied in patients with relapsed/refractory classical Hodgkin Lymphoma. The updated and final analysis were presented at the 2018 ASCO Annual Meeting in Chicago last June (3). More recently, the company also announced that the first patient has been dosed in a phase III clinical trial (ORIENT-11) studying the drug as a first-line of treatment for patients with non-squamous non-small cell lung cancer (NSCLC) (4).




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