Toripalimab Achieves Record-Breaking Long-Term Survival in Advanced Nasopharyngeal and Esophageal Cancers
核心洞察
Toripalimab plus chemotherapy demonstrated unprecedented 5-year survival benefits in nasopharyngeal carcinoma (搜索), achieving a median overall survival of 64.8 months and 52.3% five-year survival rate.
The anti-PD-1 (搜索) antibody showed sustained efficacy in esophageal squamous cell carcinoma (搜索) with a median overall survival of 17.7 months and 29.7% three-year survival rate.
These results from JUPITER-02 and JUPITER-06 trials establish new treatment standards, with toripalimab now approved in over 40 countries for these indications.
Junshi Biosciences announced breakthrough long-term survival data for toripalimab, an anti-PD-1 (搜索) monoclonal antibody, demonstrating record-setting efficacy in treating advanced nasopharyngeal carcinoma (搜索) (NPC) and esophageal squamous cell carcinoma (搜索) (ESCC). The results from two pivotal Phase 3 trials were presented at the European Society for Medical Oncology (ESMO) Asia Congress 2025.
JUPITER-02 Sets New Standard for Nasopharyngeal Carcinoma
The JUPITER-02 trial's long-term follow-up analysis revealed unprecedented survival benefits for patients with recurrent or metastatic NPC. In this global multicenter, double-blind, randomized Phase 3 trial, 289 chemotherapy-naïve patients were randomized 1:1 to receive either toripalimab 240 mg or placebo combined with gemcitabine/cisplatin chemotherapy every three weeks for up to six cycles, followed by maintenance monotherapy.
By the June 24, 2025 data cut-off, patients receiving toripalimab achieved a median overall survival (mOS) of 64.8 months compared to 33.7 months with placebo—a remarkable 31.1-month extension. This translated to a 39% reduction in death risk (HR=0.62; 95%CI: 0.45-0.85; p=0.0027) and a five-year overall survival rate of 52.3% versus 33.9% for placebo.
"These remarkable results set new records for the longest survival benefit achieved with immuno-oncology therapy in certain NPC and ESCC populations, further cementing toripalimab's global leadership in immunotherapy for advanced NPC and ESCC," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences and TopAlliance Biosciences (搜索).
The survival benefits remained consistent regardless of PD-L1 (搜索) expression status, demonstrating broad applicability across patient populations. As the first trial to confirm survival benefits with first-line immunotherapy for NPC, JUPITER-02 has established toripalimab plus chemotherapy as the new global standard, with approval in over 40 countries and endorsement by three major international guidelines (CSCO, NCCN, and ESMO).
JUPITER-06 Confirms Sustained Benefits in Esophageal Cancer
The JUPITER-06 trial evaluated toripalimab in combination with paclitaxel plus cisplatin chemotherapy versus placebo plus chemotherapy in 514 systemic treatment-naïve patients with advanced or metastatic ESCC. The study featured dual primary endpoints of progression-free survival and overall survival assessed by blinded independent central review.
The final overall survival analysis, with a median follow-up of 14.2 months, demonstrated that toripalimab achieved a mOS of 17.7 months versus 12.9 months in the placebo arm, representing a 28% reduction in death risk (HR=0.72, 95% CI: 0.58–0.88; P=0.002). The two-year and three-year overall survival rates were 39.1% versus 27.1% and 29.7% versus 19.9%, respectively.
Subgroup analyses showed consistent overall survival benefits across all patient populations, with improved outcomes in the toripalimab arm regardless of PD-L1 (搜索) expression status. Long-term follow-up revealed no new safety signals, with treatment-emergent adverse events comparable between arms (97.3% incidence rate in both groups).
Breakthrough in Precision Medicine
A significant advancement from JUPITER-06 was the development of translational research that systematically identified predictive biomarkers for anti-PD-1 (搜索) antibody plus chemotherapy combinations. This work established the world's first Esophageal Genomic Immunophenotype Classification (EGIC), a framework that prospectively identifies precision-targeted strategies for patients who respond poorly to chemo-immunotherapy.
This classification system represents a practice-changing approach for guiding individualized clinical therapy and developing future combination strategies, addressing a critical unmet need in personalizing cancer treatment.
Global Impact and Regulatory Success
Toripalimab has gained approval for first-line treatment of advanced ESCC in China, the European Union, and multiple other countries. Notably, it stands as Europe's first anti-PD-1 (搜索) antibody approved for first-line advanced ESCC treatment regardless of PD-L1 (搜索) expression status.
The drug's mechanism involves blocking PD-1 (搜索) interactions with its ligands PD-L1 (搜索) and PD-L2 (搜索), while inducing PD-1 receptor internalization. This dual action promotes the immune system's ability to attack and kill tumor cells.
In China, toripalimab was the first domestically produced anti-PD-1 (搜索) monoclonal antibody approved for marketing, with twelve current indications including various cancer types. Ten of these indications are included in China's National Reimbursement Drug List, making toripalimab the only anti-PD-1 antibody covered for melanoma (搜索), perioperative NSCLC treatment, renal cell carcinoma (搜索), and triple-negative breast cancer (搜索).
The comprehensive clinical development program for toripalimab includes more than 40 company-sponsored studies covering over 15 indications globally, spanning cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.