The following article features coverage from the AACR Annual Meeting 2022. Click here to read more of Cancer Therapy Advisor’s conference coverage.

Adding toripalimab to standard first-line chemotherapy improved progression-free survival (PFS) in patients with advanced nasopharyngeal carcinoma (NPC), according to results of the phase 3 JUPITER-02 trial.

Patients who received toripalimab plus gemcitabine-cisplatin (GP) had a 13.2-month improvement in PFS, compared with patients who received GP alone.

“Toripalimab plus GP represents a new standard of care as first-line therapy for patients with [recurrent or metastatic] NPC,” the researchers wrote.  

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The team reported these findings in a poster at the AACR Annual Meeting 2022.  

The JUPITER-02 trial ( Identifier: NCT03581786) enrolled 289 patients with recurrent or metastatic NPC who had received no prior chemotherapy.

The patients were randomly assigned to receive toripalimab at 240 mg (n=146) or placebo (n=143) in combination with GP every 3 weeks for up to 6 cycles. This was followed by monotherapy with toripalimab or placebo every 3 weeks until disease progression, intolerable toxicity, or the completion of treatment at 2 years. 

At the data cutoff (June 8, 2021), the median follow-up was 22.1 months in the toripalimab arm and 21.4 months in the placebo arm.

By blinded independent review, the median PFS was superior in the toripalimab arm. The median PFS was 21.4 months in the toripalimab arm and 8.2 months in the GP-alone arm (hazard ratio [HR], 0.52; 95% CI, 0.37-0.73; P <.0001). 

The 1-year PFS rate was 59.0% in the toripalimab arm and 32.9% in the placebo arm. The 2-year PFS rate was 44.8% and 25.4%, respectively.

The researchers noted PFS improvements in the toripalimab arm across key subgroups, including by baseline disease stage and PD-L1 expression. The team also noted that a reduction in plasma Epstein-Barr virus DNA copy number from baseline was associated with a favorable response.

The objective response rate was significantly higher in the toripalimab arm than in the placebo arm — 78.8% and 67.1%, respectively (P =.0221). The complete response rate was 26.7% and 13.3%, respectively. 

The median duration of response was significantly longer with toripalimab than with placebo — 18.0 months and 6.0 months, respectively (HR, 0.49; 95% CI, 0.33-0.72; P =.0003). 

Although the median overall survival (OS) was not reached in either arm, the OS analysis revealed a trend favoring the toripalimab arm over the placebo arm (HR, 0.59; 95% CI, 0.37-0.94; P =.0238). 

The 1-year OS rate was 91.6% in the toripalimab arm and 87.1% in the placebo arm. The 2-year OS rate was 75.1% and 63.9%, respectively.

The rate of grade 3 or higher adverse events (AEs) was similar between the toripalimab arm and the placebo arm — 89.7% and 90.2%, respectively. The rate of fatal AEs was 2.7% and 2.8%, respectively. 

Investigator-determined immune-related AEs were more frequent in the toripalimab arm than in the placebo arm — 53.4% and 21.7%, respectively. The rate of grade 3 or higher immune-related AEs was 8.9% and 1.4%, respectively.

Disclosures: This research was supported by Shanghai Junshi Biosciences and Coherus Biosciences. Please see the original reference for a full list of disclosures.

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Mai H-Q, Chen Q-Y, Chen D, et al. Final progression-free survival analysis of JUPITER-02, a randomized, double-blind, phase 3 study of toripalimab or placebo plus gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma. Presented at AACR 2022; April 8-13, 2022. Abstract CT226/5.