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Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial
Ist Teil von
Cancer cell, 2022-03, Vol.40 (3), p.277-288.e3
Ort / Verlag
United States: Elsevier Inc
Erscheinungsjahr
2022
Quelle
MEDLINE
Beschreibungen/Notizen
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.
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•First-line toripalimab plus chemotherapy for esophageal squamous cell carcinoma•Toripalimab plus chemotherapy improves progression-free survival and overall survival•Toripalimab plus chemotherapy is efficacious irrespective of PD-L1 expression•Toripalimab plus chemotherapy shows a manageable safety profile
Wang et al. demonstrate the efficacy and safety of toripalimab plus paclitaxel/cisplatin as the first-line treatment for patients with advanced esophageal squamous cell carcinoma. As compared with paclitaxel/cisplatin alone, toripalimab plus paclitaxel/cisplatin extends progression-free survival and overall survival of the patients irrespective of PD-L1 expression.