Biomarker analysis in JUPITER-06 identified the Esophageal Genomic Immunophenotype Classification (EGIC), aiming to guide precision strategies for patients less responsive to chemo-immunotherapy.

The JUPITER-02 trial enrolled 289 chemo-naïve R/M NPC patients, comparing toripalimab 240 mg plus GP versus placebo plus GP, with OS as a key secondary endpoint and data cut-off on June 24, 2025.

Toripalimab is an anti-PD-1 antibody developed by Junshi Biosciences, with over forty clinical studies across more than fifteen indications and approvals in major markets including the US, EU, China, and parts of Asia.

The article highlights Junshi Biosciences’ development of toripalimab, its global regulatory footprint, ongoing pivotal studies, mechanism of PD-1 blockade, and future directions.

The trials are randomized, double-blind phase 3 studies with primary endpoints including OS, PFS, and ORR, and they carry translational research implications for precision oncology in NPC and ESCC.

The JUPITER-02 and JUPITER-06 results were presented at ESMO Asia 2025, cementing toripalimab’s leadership in treating advanced NPC and ESCC.

Toripalimab has approvals for first-line advanced ESCC in multiple regions, including Europe, with biomarker analyses in JUPITER-06 supporting activity across PD-L1 subgroups.

In the JUPITER-02 study, adding toripalimab to gemcitabine/cisplatin reduced the risk of death by 39% (HR 0.62) compared with GP alone, based on the final OS analysis through June 24, 2025.

In China, toripalimab has twelve approved indications, including first-line treatment combinations for NPC and ESCC, and is listed in the NRDL for multiple indications such as melanoma and NSCLC perioperative treatment.

The JUPITER-06 trial shows a sustained survival benefit for toripalimab plus chemotherapy in advanced esophageal squamous cell carcinoma (ESCC), with a final OS analysis revealing a median OS of 17.7 months for toripalimab vs 12.9 months for placebo (HR 0.72; p=0.002), and 2- and 3-year OS rates of 39.1% vs 27.1% and 29.7% vs 19.9%, respectively.

For recurrent/metastatic nasopharyngeal carcinoma (R/M NPC), toripalimab plus chemotherapy achieved long-term OS benefits, with a median OS of 64.8 months and a 5-year OS rate of 52.3% in JUPITER-02.

Toripalimab plus GP is approved in over 40 countries and regions and is endorsed as a new standard of care for first-line R/M NPC by CSCO, NCCN, and ESMO guidelines.

JUPITER-06 enrolled 514 treatment-naïve ESCC patients, comparing toripalimab plus paclitaxel/cisplatin versus placebo plus TP, with dual primary endpoints of PFS and OS assessed by BICR, and the EGIC framework as a first biomarker to guide personalized chemo-immunotherapy.

Results from JUPITER-02 have led to toripalimab’s approval in more than 40 countries and its endorsement in three major guidelines (CSCO, NCCN, ESMO) for first-line R/M NPC.

Long-term follow-up showed no new safety signals, with treatment-emergent adverse events occurring at similar rates (~97.3%) between the toripalimab and placebo arms.