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The frontline combination of toripalimab and cisplatin/paclitaxel reached its prespecified primary end points of progression-free and overall survival in patients with advanced esophageal squamous cell carcinoma in the phase 3 JUPITER-06 trial.
The frontline combination of toripalimab and cisplatin/paclitaxel reached its prespecified primary end points of progression-free and overall survival (OS) in patients with advanced esophageal squamous cell carcinoma (ESCC) in the phase 3 JUPITER-06 trial (NCT03829969), according to a determination by the Independent Data Monitoring Committee (IDMC).1
Junshi Biosciences, the developer of toripalimab, stated that it will be communicating with regulatory authorities regarding a supplemental new drug application for the investigational PD-1 inhibitor in the ESCC setting in the near future.
“Based on the results of interim analysis, the Independent Data Monitoring Committee determined that both primary endpoints of [progression-free survival] and OS have crossed the prespecified efficacy boundaries and the results show that compared with the paclitaxel/cisplatin chemotherapy, toripalimab combined with paclitaxel/cisplatin significantly prolonged the PFS and OS of patients with advanced esophageal squamous carcinoma,” the company stated.
Esophageal cancer is the seventh most common malignancy worldwide and is the sixth leading cause of cancer mortality. There were 320,000 new esophageal cancer cases and an estimated 300,000 deaths related to the cancer type that occurred in China. Esophageal squamous cell carcinoma and adenocarcinoma are the 2 main esophageal cancer histologies.
Currently, platinum-based chemotherapy is the standard first-line therapy; 5-year OS rates with this treatment approach is less than 20%.
Toripalimab is granted a conditional approval from the China National Medical Products Administration as a second-line treatment of patients with unresectable or metastatic melanoma, and also has a conditional approval as a treatment for patients with recurrent or metastatic nasopharyngeal carcinoma following failure of at least 2 lines of prior systemic therapy. An indication in the frontline nasopharyngeal cancer setting is currently being reviewed by the China NMPA.
In April 2021, a supplemental new drug application for toripalimab was granted a conditional approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 1 year of neoadjuvant or adjuvant platinum-containing chemotherapy.
Toripalimab currently has fast track status with the FDA as a frontline treatment for patients with mucosal melanoma, which was granted in January 2021.2 In March 2021, a biologics license application was initiated with the FDA for toripalimab as a treatment for patients with recurrent or metastatic nasopharyngeal carcinoma.3
In the randomized, double-blind, placebo-controlled, multicenter, phase 3 JUPTIER-06 trial, investigators are comparing the efficacy and safety of toripalimab plus cisplatin/paclitaxel with placebo plus cisplatin/paclitaxel in the first-line setting in 514 patients with advanced ESCC. Toripalimab and placebo will each be administered via injection.
To be eligible for enrollment, patients need to have locally advanced/metastatic ESCC without radical treatment, and no prior systemic antitumor treatment is permitted. Patients could not have had disease recurrence at least 6 months from the end of their last treatment in the neoadjuvant or adjuvant setting. Patients needed to have at least 1 measurable lesion via RECIST v1.1 criteria and adequate organ function.
The co-primary end points are progression-free survival (PFS) as assessed by blinded independent central review (BICR) and OS; secondary end points include investigator-assessed PFS, objective response rate, disease control rate, and duration of response.