# JUPITER-02: toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma

Source: https://onco.cc/key-papers/paper-jupiter-02-toripalimab-chemotherapy-npc-nat-med-2021/  
OnCo record `paper-jupiter-02-toripalimab-chemotherapy-npc-nat-med-2021` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding the PD-1 antibody toripalimab to gemcitabine and cisplatin lengthened the time before metastatic nasopharyngeal cancer progressed by about four months, and later improved survival, making chemo-immunotherapy the first-line standard.

## Summary

International randomised double-blind placebo-controlled phase 3 trial of 289 patients with recurrent or metastatic nasopharyngeal carcinoma assigned to toripalimab or placebo with gemcitabine and cisplatin, followed by toripalimab or placebo maintenance.

Median progression-free survival was 11.7 months with toripalimab against 8.0 months (hazard ratio 0.52) at the interim analysis, with benefit regardless of PD-L1 expression; the final analysis (JAMA 2023) showed improved overall survival. Toripalimab was approved in China in 2021 and by the FDA in 2024.

## Fields

- Kind: Key paper
- Last checked: 2026-09-18
- Journal: Nature Medicine
- Year: 2021
- DOI: 10.1038/s41591-021-01444-0
- Authors: Mai HQ, Chen QY, Chen D, et al.
- Findings: Median progression-free survival 11.7 months with toripalimab plus chemotherapy versus 8.0 months with chemotherapy alone; hazard ratio 0.52.; Benefit irrespective of PD-L1 status; overall survival improved at final analysis.
- What it means: PD-1 blockade with gemcitabine and cisplatin is the first-line standard for recurrent or metastatic nasopharyngeal carcinoma, and the first immunotherapy approved for this cancer in the United States.
- Caveats: Conducted in mainland China, Taiwan and Singapore; almost all patients had EBV-related non-keratinising disease.; Immune-related adverse events, including hypothyroidism, were more frequent.

## Sources

- Nat Med 2021: https://doi.org/10.1038/s41591-021-01444-0
- PubMed: https://pubmed.ncbi.nlm.nih.gov/34341578/

## Connected records

- cancers: [Recurrent and metastatic nasopharyngeal carcinoma](https://onco.cc/cancers/recurrent-metastatic-nasopharyngeal-carcinoma/)
- drugs: [Gemcitabine + cisplatin](https://onco.cc/drugs/gemcitabine-cisplatin/), [Toripalimab](https://onco.cc/drugs/toripalimab/)
- trials: [JUPITER-02](https://onco.cc/trials/jupiter-02/)
- journals: [Nature Medicine](https://onco.cc/journals/nature-medicine/)

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