Innovent Biologics Inc., the China-based one leading biopharmaceutical company that develops, manufactures, and distributes top-notch medicines for the treatment of metabolic, oncology, autoimmune diseases, has reportedly announced that its ‘ORIENT-32’ clinical trial has met primary endpoints of PFS (progression-free survival) and OS (overall survival) in an interim study.
For the record, ORIENT-32 is a phase 3 randomized, open-label clinical trial assessing TYVYT® (sintilimab injection) together with BYVASDA® (bevacizumab biosimilar injection, or IBI305) in order to develop a novel first-line treatment for advanced HCC( hepatocellular carcinoma) patients.
Registered patients were randomly allocated 2:1 to receive TYVYT® together with BYVASDA® or sorafenib until unacceptable toxicity, disease progression, death, withdrawal of consent, or other numerous reasons mentioned in the protocol, whichever happens first.
Sources cite that TYVYT® together with BYVASDA® showed a statistically considerable improvement in OS and PFS compared with sorafenib. The safety profile of this combination in this clinical trial was also consistent with earlier reported studies, and no novel safety signals were recognized.
Innovent Biologics said in the statement that interim analysis has been conducted by IDMC (Independent Data Monitoring Committee). The company said it is planning to review these outcomes with CDE (Drug Evaluation Center) of NMPA (National Medical Products Administration) and will represent these data at the forthcoming medical conference.
Speaking on which, Dr. Hui Zhou who is the Vice President as well as Head of Oncology Strategy and Medical Sciences at Innovent said that the outcomes of the ORIENT-32 clinical study show the potential of TYVYT® together with BYVASDA® to treat HCC patients in the first-line setting.
He added that exceptional contributions were made through the combined efforts of study team and investigators, despite the impact and challenges from the COVID-19 pandemic. He also thanked all patients and investigators who took part in the ORIENT-32 clinical trial.
Source credit- https://www.prnewswire.com/news-releases/tyvyt-sintilimab-injection-in-combination-with-byvasda-bevacizumab-injection-orient-32-study-met-its-primary-endpoints-of-progression-free-survival-and-overall-survival-in-the-first-line-treatment-of-patients-with-advanced-h-301138710.html