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Adding toripalimab to first-line treatment with gemcitabine and cisplatin improves survival in patients with recurrent or metastatic nasopharyngeal carcinoma, according to research published in JAMA.1
The progression-free survival (PFS) and overall survival (OS) gains seen in this study support the use of toripalimab, gemcitabine, and cisplatin as the new standard of care for these patients, according to researchers.
These results come from the phase 3 JUPITER-02 trial (ClinicalTrials.gov Identifier: NCT03581786).
The trial included 289 patients with recurrent or metastatic nasopharyngeal carcinoma. They were randomly assigned to receive either toripalimab (n=146) or placebo (n=143), each in combination with gemcitabine-cisplatin chemotherapy for up to 6 cycles, followed by maintenance with toripalimab or placebo for up to 2 years.
At a median follow-up of 36.0 months, toripalimab reduced the risk of death by 37%. The median OS was not reached with toripalimab-chemotherapy and was 33.7 months with chemotherapy alone (hazard ratio [HR], 0.63; 95% CI, 0.45-0.89; P =.008).
“The significant improvement in overall survival was achieved despite extensive crossover to immunotherapy,” the researchers noted. “At the final overall survival analysis, for patients who had experienced disease progression, 48 of 104 (46%) in the toripalimab group and 49 of 123 (40%) in the control group received later-line anti-PD-1/PD-L1 therapy.”
Toripalimab also reduced the risk of progression or death by 48%. The median PFS was 21.4 months with toripalimab-chemotherapy and 8.2 months with chemotherapy alone (HR, 0.52; 95% CI, 0.37-0.73; P <.001). The 2-year PFS rate was 44.8% and 25.4%, respectively.
The overall response rate was 78.8% with toripalimab and 67.1% with placebo (P =.02). The complete response rates were 26.7% and 13.3%, respectively. The median duration of response was 18.0 months and 6.0 months, respectively (P <.001).
The rate of grade 3 or higher adverse events (AEs) was 89.7% in the toripalimab arm and 90.2% in the chemotherapy-alone arm. The rate of serious AEs was 43.8% and 43.4%, respectively. The rate of fatal AEs was 3.4% and 2.8%, respectively.
AEs that were more common in the toripalimab arm than in the chemotherapy-alone arm were hypothyroidism (36.3% vs 17.5%), upper respiratory infection (25.3% vs 14.0%), and pneumonia (17.8% vs 7.0%). Patients in the toripalimab arm also had a higher rate of immune-related AEs (54.1% vs 21.7%) and grade 3 or higher immune-related AEs (9.6% vs 1.4%).
“These findings support the use of toripalimab plus gemcitabine-cisplatin as the new standard of care for this patient population,” the researchers concluded.
On the basis of these findings, the US Food and Drug Administration approved toripalimab with cisplatin and gemcitabine for the treatment of recurrent or metastatic nasopharyngeal carcinoma.2
Disclosures: This research was supported by Shanghai Junshi Biosciences and Coherus Biosciences. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
References
1. Mai H-Q, Chen Q-Y, Chen D, et al. Toripalimab plus chemotherapy for recurrent or metastatic nasopharyngeal carcinoma: The JUPITER-02 randomized clinical trial. JAMA. Published online November 28, 2023. doi:10.1001/jama.2023.20181
2. FDA approves toripalimab-tpzi for nasopharyngeal carcinoma. US Food & Drug Administration. Updated October 30, 2023. Accessed December 13, 2023.
This article originally appeared on Cancer Therapy Advisor
