SUZHOU, China I May 16, 2018 I Innovent Biologics (Suzhou) Co. Ltd. (Innovent Biologics) today 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). The preliminary result of the ORIENT-1 trial was published at ASCO’s official website on May 16, 2018. The updated and final analysis on its primary endpoint mentioned in this press release will be presented at the 2018 ASCO Annual Meeting in Chicago in a poster session on Saturday, June 4, 2018.
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 radiographic 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 commercialize 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.
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 jointly developed by Innovent Biologics and Eli Lilly and Company in China. It is also the first drug submitted for NDA by Innovent Biologics.
About ORIENT-1 Trial
ORIENT-1 (NCT03114683) is a multicenter, single-arm, phase 2 registrational study assessing the efficacy and safety profile of IBI308. A total 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 radiographic 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.
The study requires that the assessment of CR can only be performed by PET at week 15. Therefore, the CR data only represents a single point assessment at week 15.
About Relapsed/Refractory classical Hodgkin Lymphoma (r/r cHL)
Hodgkin Lymphoma is a relatively rare B cell malignancy, often seen in population aged between 20 and 40, and most of the patients are classic in terms of pathology subgroup. Although the current treatment for HL is very efficacious with high cure rate, about 20% of them will relapse after initial treatment due to treatment failure or intolerance to drug treatment. How to treat r/r cHL effectively is a serious challenge among oncology and hematology community. The average survival is only 1-2 years once a patient relapses after autologous hematopoietic stem cell transplantation (HSCT).
About Innovent Biologics
Innovent Biologics, a leading biopharmaceutical company in China, was established in 2011. Its core business is to develop and commercialize therapeutic antibodies for complex and debilitating diseases. As of today, Innovent Biologics has established a pipeline composed of 16 monoclonal antibody products, covering four major disease areas: oncology, ophthalmology, autoimmune diseases, and cardiovascular diseases. Seven candidates are in clinical stage, four of them are in phase 3 clinical trials and Sintilimab has been accepted for NDA by CFDA with a designation of priority review. In addition, Innovent Biologics designs and builds its manufacturing facilities in accordance with the GMP standards of the CFDA, FDA and EMA. Three production lines have passed the audits conducted by a global biopharmaceutical company in accordance with its global standards.
Innovent Biologics has attracted private financing from a number of world-renowned VC firms, including Fidelity, Lilly Asia Venture, Capital Group, Legend Capital, Temasek, SDIC, China Life, and Hillhouse Capital and has established a deep strategic partnership with Eli Lilly.
Inspired by its corporate spirit of “Start with Integrity, Succeed by Action,” Innovent Biologics’ mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people.
About the partnership between Innovent Biologics and Lilly
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 which has already been one of the largest collaboration in China between a multi-national and domestic biopharmaceutical company. 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.
SOURCE: Innovent Biologics
Post Views: 284
SUZHOU, China I May 16, 2018 I Innovent Biologics (Suzhou) Co. Ltd. (Innovent Biologics) today 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). The preliminary result of the ORIENT-1 trial was published at ASCO’s official website on May 16, 2018. The updated and final analysis on its primary endpoint mentioned in this press release will be presented at the 2018 ASCO Annual Meeting in Chicago in a poster session on Saturday, June 4, 2018.
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 radiographic 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 commercialize 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.
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 jointly developed by Innovent Biologics and Eli Lilly and Company in China. It is also the first drug submitted for NDA by Innovent Biologics.
About ORIENT-1 Trial
ORIENT-1 (NCT03114683) is a multicenter, single-arm, phase 2 registrational study assessing the efficacy and safety profile of IBI308. A total 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 radiographic 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.
The study requires that the assessment of CR can only be performed by PET at week 15. Therefore, the CR data only represents a single point assessment at week 15.
About Relapsed/Refractory classical Hodgkin Lymphoma (r/r cHL)
Hodgkin Lymphoma is a relatively rare B cell malignancy, often seen in population aged between 20 and 40, and most of the patients are classic in terms of pathology subgroup. Although the current treatment for HL is very efficacious with high cure rate, about 20% of them will relapse after initial treatment due to treatment failure or intolerance to drug treatment. How to treat r/r cHL effectively is a serious challenge among oncology and hematology community. The average survival is only 1-2 years once a patient relapses after autologous hematopoietic stem cell transplantation (HSCT).
About Innovent Biologics
Innovent Biologics, a leading biopharmaceutical company in China, was established in 2011. Its core business is to develop and commercialize therapeutic antibodies for complex and debilitating diseases. As of today, Innovent Biologics has established a pipeline composed of 16 monoclonal antibody products, covering four major disease areas: oncology, ophthalmology, autoimmune diseases, and cardiovascular diseases. Seven candidates are in clinical stage, four of them are in phase 3 clinical trials and Sintilimab has been accepted for NDA by CFDA with a designation of priority review. In addition, Innovent Biologics designs and builds its manufacturing facilities in accordance with the GMP standards of the CFDA, FDA and EMA. Three production lines have passed the audits conducted by a global biopharmaceutical company in accordance with its global standards.
Innovent Biologics has attracted private financing from a number of world-renowned VC firms, including Fidelity, Lilly Asia Venture, Capital Group, Legend Capital, Temasek, SDIC, China Life, and Hillhouse Capital and has established a deep strategic partnership with Eli Lilly.
Inspired by its corporate spirit of “Start with Integrity, Succeed by Action,” Innovent Biologics’ mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people.
About the partnership between Innovent Biologics and Lilly
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 which has already been one of the largest collaboration in China between a multi-national and domestic biopharmaceutical company. 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.
SOURCE: Innovent Biologics
Post Views: 284
