After 6 years of follow-up, toripalimab-tpzi (Loqtorzi) plus chemotherapy maintained its survival advantage over chemotherapy alone in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC), according to long-term overall survival (OS) findings from the phase 3 JUPITER-02 study (NCT03581786).1
In this exploratory post-hoc analysis, findings from which were presented at the 2025 ESMO Asia Congress, patients treated with toripalimab plus gemcitabine and cisplatin achieved a median OS of 64.8 months vs 33.7 months with chemotherapy alone. This translated to a 31-month improvement and a 38% reduction in the risk of death (HR 0.62; 95% CI, 0.45-0.85). Coherus Oncology, the drug’s developer, stated that these results reinforce the regimen’s role in the recurrent/metastatic setting.
“The new 6-year overall survival follow-up data give us even greater confidence to use toripalimab in patients with NPC that is recurrent or metastatic,” Victoria Villaflor, MD, professor and director of the Head and Neck Oncology Program in the Division of Hematology-Oncology, Department of Medicine, at the University of California Irvine School of Medicine, stated in a news release.
“These data suggest a significant long-term OS benefit for patients living with [recurrent/metastatic] NPC,” Rosh Dias, MD, chief medical officer of Coherus Oncology, added in the news release. “With these long-term data, [toripalimab] in combination with chemotherapy, reinforces the data supporting this regimen as the standard of care for patients living with [recurrent/metastatic] NPC.”
Long-Term OS Updates From JUPITER-02: Topline Takeaways
- Findings from an exploratory post-hoc analysis showed that toripalimab plus gemcitabine and cisplatin produced a median OS of 64.8 months vs 33.7 months with chemotherapy alone after 6 years of follow-up.
- This translated to a 31-month OS improvement and a 38% reduction in risk of death (HR 0.62; 95% CI, 0.45-0.85).
- Taken together with the efficacy and safety findings from JUPITER-02 to date, these updated data reinforce the regimen’s role as a standard of care in the recurrent/metastatic setting.
What was the design of JUPITER-02?
The JUPITER-02 was a randomized, double blind, placebo-controlled study that evaluated the addition of PD-1 blockade to standard chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma.
The trial enrolled 289 patients with metastatic or recurrent, locally advanced NPC who had not received previous systemic chemotherapy for recurrent or metastatic disease.2 Patients were randomly assigned 1:1 to receive toripalimab at 240 mg every 3 weeks or the corresponding dose of placebo before receiving chemotherapy every 3 weeks for up to 6 cycles, followed by either toripalimab or placebo maintenance for up to 2 years.2,3 The chemotherapy regimen included 1,000 mg/m2 of administered intravenous (IV) gemcitabine administered on days 1 and 8 and 80 mg/m² of IV cisplatin on day 1 of each cycle.
The primary end point was progression-free survival (PFS) according to RECIST 1.1 criteria.2 Key secondary end points included OS, overall response rate, disease control rate, duration of response, and safety.
What prior data have been reported from this trial?
In JUPITER-02, the combination reduced the risk of disease progression or death by 48% vs chemotherapy alone (HR, 0.52; 95% CI, 0.36-0.74; P < .0003).4 The median PFS was 11.7 months (95% CI, 11.0–not evaluable [NE]) in the combination arm (n = 146) vs 8.0 months (95% CI, 7.0-9.5) in the control arm (n = 143).2 The median OS was not reached (95% CI, 38.7 months, not estimable) with the toripalimab combination vs 33.7 months (95% CI, 27.0, 44.2) with chemotherapy alone (95% CI, 27.0-44.2).4 This translated to a 37% reduction in the risk of death vs chemotherapy alone (HR, 0.63; 95% CI, 0.45-0.89; P = .0083).
These results supported the 2023 FDA approval of toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with metastatic or recurrent locally advanced nasopharyngeal carcinoma.2 The FDA also approved toripalimab as monotherapy for patients with recurrent unresectable or metastatic NPC who progressed on or after platinum- containing chemotherapy based on findings from the phase 2 POLARIS-02 trial (NCT02915432).
What are the key safety considerations for toripalimab plus chemotherapy?
Toripalimab is often associated with immune-mediated adverse effects (AEs) such as pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, and skin adverse reactions.1
The most frequently observed (≥ 20%) AEs with toripalimab plus chemotherapy included nausea, vomiting, decreased appetite, constipation, hypothyroidism, rash, pyrexia, diarrhea, peripheral neuropathy, cough, musculoskeletal pain, upper respiratory infection, insomnia, dizziness, and malaise.
References
- Coherus announces six-year JUPITER-02 follow-up results showing LOQTORZI plus chemotherapy nearly doubles median overall survival in nasopharyngeal carcinoma. News release. Coherus. December 8, 2025. Accessed December 8, 2025. https://investors.coherus.com/news-releases/news-release-details/coherus-announces-six-year-jupiter-02-follow-results-showing
- The efficacy and safety study of toripalimab injection combined with chemotherapy for nasophapyngeal cancer. ClinicalTrials.gov. Updated September 2, 2025. Accessed December 8, 2025. https://www.clinicaltrials.gov/ct2/show/NCT03581786
- FDA approves toripalimab-tpzi for nasopharyngeal carcinoma. FDA. October 27, 2023. Accessed December 8, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-toripalimab-tpzi-nasopharyngeal-carcinoma
- Coherus and Junshi Biosciences announce FDA approval of Loqtorzi (toripalimab-tpzi) in all lines of treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC). News release. Coherus BioSciences and Shanghai Junshi Biosciences. October 27, 2023. Accessed December 8, 2025. https://investors.coherus.com/news-releases/news-release-details/coherus-and-junshi-biosciences-announce-fda-approval-loqtorzitm
