Innovent Biologics, along with Eli Lilly has apparently announced that the Phase 2 TYVYT® ORIENT-2 study met overall survival’s primary endpoint in China.
Innovent and Lilly are reportedly contemplating to discuss the results with National Medical Products Administration (NMPA)’s Drug Evaluation Center (CDE) in China.
The randomized study allegedly assessed TYVYT monotherapy as compared to chemotherapy. This is said to be the second-line treatment for patients with sophisticated or metastatic esophageal squamous cell carcinoma (ESCC) exhibited a noticeable enhancement in overall survival (OS).
According to sources, TYVYT’s safety profile is in line with the priorly reported results of TYVYT study; while, new safety signals have apparently not been identified. The in-depth results are likely to be reported in an ASCO 2020 poster discussion session.
Professor Jianming Xu, the principal investigator of the ORIENT-2 study, claimed that the case of ESCC in Asian countries has been higher vis-à-vis in western countries.
The present standard of treatment is said to have been based on radiation therapy and traditional chemotherapy. Reportedly, traditional chemotherapy drugs are believed to have exhibited a confined effect on patients’ second-line treatment of patients with sophisticated ESCC.
Vice President and Head of Oncology Strategy and Medical Sciences of Innovent Dr. Hui Zhou noted that TYVYT received the green signal from NMPA in 2018 for the treatment of refractory or relapsed classic Hodgkin’s lymphoma post later systematic or second-line chemotherapy.
Zhou claims to have over 20 clinical studies to assess the effectiveness of TYVYT in other types of tumors. He went on to state that there were conducting a Phase 3 trial to assess TYVYT along with chemotherapy as a first-line treatment with recurrent, sophisticated or metastatic ESCC. He expects these clinical trials to offer more efficacious treatment alternatives for upsides and clinicians ESCC patients.