Long-term results from the phase III JUPITER-02 trial demonstrate that adding toripalimab (PD-1 inhibitor) to gemcitabine and cisplatin continues to deliver a meaningful survival advantage in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC)—even after six years of follow-up. This durable effect reinforces the combination as a standard first-line regimen in this disease setting.
Survival Outcomes After Six Years
In an exploratory post-hoc analysis presented at ESMO Asia 2025, patients treated with toripalimab + chemotherapy achieved:
- Median OS: 64.8 months
vs 33.7 months with chemotherapy alone - 31-month improvement in overall survival
- 38% reduction in risk of death
(HR 0.62; 95% CI, 0.45–0.85)
This represents one of the longest OS gains ever reported in metastatic NPC, highlighting durable immune-controlled disease in a subset of patients.
Toripalimab (Loqtorzi): Uses in Cancer, Side Effects, Dosage, Expectations, and More
About the JUPITER-02 Trial
JUPITER-02 was a phase III, randomized, double-blind, placebo-controlled study designed to determine whether the addition of PD-1 inhibition to standard platinum-based chemotherapy could improve outcomes in recurrent or metastatic nasopharyngeal carcinoma (NPC).
A total of 289 patients with previously untreated recurrent/metastatic locally advanced NPC were enrolled and randomly assigned in a 1:1 ratio to receive either toripalimab or placebo, both in combination with gemcitabine and cisplatin for up to six treatment cycles. After induction, patients continued on maintenance therapy with toripalimab or placebo for up to two years, or until disease progression or unacceptable toxicity.
The chemotherapy backbone consisted of gemcitabine 1000 mg/m² administered intravenously on days 1 and 8, combined with cisplatin 80 mg/m² IV on day 1, within 21-day treatment cycles.
The study’s primary endpoint was progression-free survival (PFS). Key secondary endpoints included overall survival, objective response rates, duration of response, and safety.
Earlier Efficacy Results
Prior published outcomes already established strong benefit:
- Median PFS: 11.7 vs 8.0 months
- 48% reduction in progression/death risk (HR 0.52)
- Median OS not reached at early analysis vs 33.7 months control
- Led to FDA approval (2023) for first-line metastatic or recurrent NPC
Additionally, toripalimab monotherapy is approved post-platinum based on POLARIS-02.
Safety Profile
Toripalimab is associated with immune-mediated toxicities that require monitoring, including:
- Pneumonitis
- Colitis
- Hepatitis
- Endocrinopathies (hypothyroidism common)
- Skin immune reactions
Most frequent treatment-related AEs (≥20%) included: Nausea, vomiting, appetite loss, constipation, hypothyroidism, rash, fever, diarrhea, neuropathy, cough, infections, dizziness, malaise.
Overall toxicity was manageable and consistent with other PD-1 regimens when used with platinum chemotherapy.
Clinical Significance
The 6-year data confirm that early integration of immunotherapy into first-line treatment provides not just incremental benefit but long-term survival durability—a major achievement for metastatic NPC, a disease historically treated with chemotherapy alone.
Toripalimab + gemcitabine/cisplatin is now firmly positioned as a first-line standard of care, offering sustained disease control and an unprecedented OS advantage.
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