Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial

TLDR

Platinum‑based chemotherapy is the standard first‑line treatment for advanced esophageal squamous cell carcinoma (ESCC). In this phase 3 trial (NCT03829969), 514 treatment‑naïve advanced ESCC patients were randomized to receive toripalimab or placebo plus paclitaxel and cisplatin every 3 weeks for up to 6 cycles, followed by maintenance with toripalimab or placebo. Toripalimab combined with TP significantly improved progression‑free survival (HR 0.58, p < 0.0001) and overall survival (HR 0.58, p = 0.0004) versus placebo plus TP, with comparable grade ≥ 3 adverse events.

Abstract

Platinum-based chemotherapy is the standard first-line treatment for advanced esophageal squamous cell carcinoma (ESCC). In this phase 3 study (ClinicalTrial.gov: NCT03829969), 514 patients with treatment-naïve advanced ESCC were randomized (1:1) to receive toripalimab or placebo in combination with paclitaxel plus cisplatin (TP) every 3 weeks for up to 6 cycles, followed by toripalimab or placebo maintenance. At the prespecified final analysis of progression-free survival (PFS), a significant improvement in PFS is observed for the toripalimab arm over the placebo arm (hazard ratio [HR] = 0.58; 95% CI, 0.46–0.74; p < 0.0001). The prespecified interim analysis of overall survival (OS) also reveals a significant OS improvement for patients treated with toripalimab plus TP over placebo plus TP (HR = 0.58; 95% CI, 0.43–0.78; p = 0.0004). The incidences of grade ≥3 treatment-emergent adverse events are similar between the two arms. Toripalimab plus TP significantly improves PFS and OS in patients with treatment-naïve, advanced ESCC, with a manageable safety profile.