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Bending the Curve Trial by Trial
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JUPITER-02

Needs review

Toripalimab or placebo plus gemcitabine-cisplatin as first-line treatment of recurrent or metastatic nasopharyngeal carcinoma

Phase 3N = 289NCT03581786

Population
Recurrent or metastatic nasopharyngeal carcinoma without previous chemotherapy for recurrent or metastatic disease
Design
International, multicentre, randomised, double-blind phase 3 trial in NPC-endemic regions (mainland China, Taiwan, Singapore). 289 patients with recurrent or metastatic NPC and no previous chemotherapy for recurrent or metastatic disease were randomised 1:1 to toripalimab (240 mg; 146 patients) or placebo (143 patients) with gemcitabine-cisplatin every 3 weeks for up to 6 cycles, followed by maintenance toripalimab or placebo until progression, intolerable toxicity or 2 years. The primary endpoint was progression-free survival by blinded independent central review.
Primary endpoint
PFS
Arms
  • Toripalimab plus gemcitabine-cisplatin (experimental, n = 146): Toripalimab 240 mg with gemcitabine-cisplatin for up to 6 cycles, then toripalimab maintenance
  • Placebo plus gemcitabine-cisplatin (control, n = 143): Placebo with gemcitabine-cisplatin for up to 6 cycles, then placebo maintenance
People
Mai HQ, senior author Xu RH
PFSHR 0.52 (95% CI 0.36–0.74)Δ median PFS+3.7 monthsOSHR 0.603 (95% CI 0.364–0.997)PFSHR 0.52 (95% CI 0.37–0.73)Δ median PFS+13.2 monthsOSHR 0.63 (95% CI 0.45–0.89)
Show the numbers
Results reported for JUPITER-02
EndpointAnalysisToripalimab plus gemcitabine-cisplatinPlacebo plus gemcitabine-cisplatinEffect
PFSRandomised patients (N = 289)interimMai 2021median 11.7 monthsmedian 8 monthsHR 0.52 (95% CI 0.36–0.74)P=0.0003Progression-free survival as assessed by a blinded independent review committee (RECIST v.1.1).
OSRandomised patients (N = 289)interimMai 2021——HR 0.603 (95% CI 0.364–0.997)Overall survival at the interim analysis; the abstract describes a 40% reduction in the risk of death.
PFSRandomised patients (N = 289)finalMai 2023median 21.4 monthsmedian 8.2 monthsHR 0.52 (95% CI 0.37–0.73)Final progression-free survival analysis by blinded independent central review; no p value for this analysis in the abstract.
OSRandomised patients (N = 289)finalmedian follow-up 36 monthsMai 2023——HR 0.63 (95% CI 0.45–0.89)P=0.008Median overall survival was not reached in the toripalimab group and was 33.7 months in the placebo group. Immune-related adverse events: 54.1% vs 21.7%; grade 3 or higher immune-related adverse events: 9.6% vs 1.4%.
Results reported for JUPITER-02
EndpointAnalysisToripalimab plus gemcitabine-cisplatinPlacebo plus gemcitabine-cisplatinEffect
PFSRandomised patients (N = 289)interimMai 2021median 11.7 monthsmedian 8 monthsHR 0.52 (95% CI 0.36–0.74)P=0.0003Progression-free survival as assessed by a blinded independent review committee (RECIST v.1.1).
OSRandomised patients (N = 289)interimMai 2021——HR 0.603 (95% CI 0.364–0.997)Overall survival at the interim analysis; the abstract describes a 40% reduction in the risk of death.
PFSRandomised patients (N = 289)finalMai 2023median 21.4 monthsmedian 8.2 monthsHR 0.52 (95% CI 0.37–0.73)Final progression-free survival analysis by blinded independent central review; no p value for this analysis in the abstract.
OSRandomised patients (N = 289)finalmedian follow-up 36 monthsMai 2023——HR 0.63 (95% CI 0.45–0.89)P=0.008Median overall survival was not reached in the toripalimab group and was 33.7 months in the placebo group. Immune-related adverse events: 54.1% vs 21.7%; grade 3 or higher immune-related adverse events: 9.6% vs 1.4%.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOSPFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.520.36–0.74
OS0.6030.364–0.997
PFS0.520.37–0.73
OS0.630.45–0.89
Illustrative — modelled from reported values, not trial data. PFS, interim.
0%25%50%75%100%0510152025Months (modelled)
  • Toripalimab plus gemcitabine-cisplatin (experimental)
  • Placebo plus gemcitabine-cisplatin (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsToripalimab plus gemcitabine-cisplatinPlacebo plus gemcitabine-cisplatin
0100.0%100.0%
766.1%54.5%
1541.1%27.3%
2227.2%14.9%
2917.9%8.1%
Illustrative — modelled from reported values, not trial data. PFS, final.
0%25%50%75%100%01020304050Months (modelled)
  • Toripalimab plus gemcitabine-cisplatin (experimental)
  • Placebo plus gemcitabine-cisplatin (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsToripalimab plus gemcitabine-cisplatinPlacebo plus gemcitabine-cisplatin
0100.0%100.0%
1365.6%33.3%
2741.7%10.2%
4027.4%3.4%
5417.4%1.0%
Primary publication: Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, et al. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nat Med. 2021;27(9):1536-1543. PubMedDOI

Appears in

Sources

  1. Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, et al. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nat Med. 2021;27(9):1536-1543.

    PubMedDOI

  2. Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, et al. Toripalimab Plus Chemotherapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: The JUPITER-02 Randomized Clinical Trial. JAMA. 2023;330(20):1961-1970.

    PubMedDOI