Innovent Biologics announced the findings from the ORIENT-1 trial investigating Sintilimab, the company’s fully human anti-PD-1 therapy (IBI308), in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).

ORIENT-1 is a multicenter, single-arm, phase 2 registrational study assessing the efficacy and safety profile of IBI308. A total of ninety-six patients with r/r cHL were enrolled. It is the largest study for this indication in China.

The primary endpoint is objective response rate (ORR), defined as the percentage of study subjects who either experienced a partial response (PR) or a complete response (CR), which was assessed by independent radio graphic review committee (IRRC) according to the revised international working group response criteria for malignant lymphoma in 2007 (IWG 2007). Complete response rate (CR) is a secondary endpoint.

Based on the assessment by IRRC, among the 96 patients with a minimum 24-week follow-up, the results showed an overall response rate (ORR) of 79.2%, disease control rate (DCR) of 97.9%, meeting the pre-set statistical criteria. The median duration of response has not been reached and the majority of the patients are continuing to respond to therapy. The study did not reveal any unexpected safety issues and there is no death reported. The safety profile of Sintilimab is similar to what have been reported in connection with other anti-PD-1 antibody products developed.

The new drug application (NDA) for IBI308 for the treatment of r/r cHL was officially accepted by the Center of Drug Evaluation of the China Food and Drug Administration (CFDA) on April 19, 2018 and was granted the “Priority Review Status” on April 23, 2018.

“Sintilimab, jointly developed by Innovent Biologics and Eli Lilly and Company, is a novel anti-PD-1 antibody with global IP rights. I am very grateful for my colleagues at Innovent Biologics, various government agencies and our partner Lilly for their effort and dedication.” said Dr. Michael Yu, the founder and CEO of Innovent Biologics. “Sintilimab will bring new hope for patients with relapsed and refractory classical Hodgkin Lymphoma in China. Our mission is to develop and commercialise high quality biopharmaceutical products that are affordable to ordinary people. Now we have just completed the very first critical step toward that mission.”

“We are very pleased with the Lilly/Innovent research and development collaboration. Together, we are making progress toward our shared goal of bringing innovative medicines to China. We firmly believe that our in-depth collaboration with Innovent may bring medical advances that eventually benefit many cancer patients throughout China,” said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology.