Junshi Biological releases first-line Phase 3 study data of teriprizumab in the treatment of esophageal cancer

Text|Pharmaceutical Mission Hills

On September 18th, Junshi Biotech announced that at this ESMO annual meeting, a total of 11 latest research studies of Junshi Bio-Treplimumab will be unveiled, covering gastrointestinal tumors, lung cancer, gynecological tumors, urothelial cancer, multiple tumor types such as head and neck cancer, published in oral presentations, poster and other forms

This is a randomized, double-blind, placebo-controlled, multi-center phase 3 study (JUPITER-06 study), with Professor Ruihua Xu from the Cancer Center of Sun Yat-sen University serving as the main investigator, aiming to compare teriprizumab with paclitaxel The effectiveness and safety of cisplatin (TP chemotherapy) and placebo combined with TP chemotherapy in the first-line treatment of advanced or metastatic ESCC

A total of 514 patients with advanced or metastatic ESCC who had not received treatment were included in the JUPITER-06 study, and they were randomly assigned to the teriprizumab plus chemotherapy group (n=257) or placebo plus chemotherapy group (n=257), respectively Receive teriprizumab (240 mg) or placebo combined with TP chemotherapy (Q3W) for up to 6 cycles, and then receive teriprizumab or placebo for maintenance treatment

As of March 22, 2021, as assessed by the BICR, the median PFS of the teriprolizumab group and the placebo group were 5.

At the same time, compared with chemotherapy alone, the combination of teriprizumab and chemotherapy significantly prolonged the patient's survival, with a median OS of 17.

The results of the study show that the addition of teriprizumab to the standard first-line TP chemotherapy regimen can enable patients with advanced or metastatic ESCC to obtain better PFS and OS, significantly reduce the patient’s risk of disease progression or death, and significantly improve survival benefits , And benefit regardless of PD-L1 expression

Junshi Biosciences and its partner Coherus plan to submit to the US FDA in 2022 a biologics license application (BLA) for teriprizumab combined with platinum-containing chemotherapy for the first-line treatment of advanced or metastatic ESCC indications

Reference materials:

[1]ESMO21 | Junshi Biological released the first-line phase III study data of teriprizumab in the first-line treatment of esophageal cancer at the annual meeting of the European Society of Medical Oncology.