Toripalimab Presents Long-Term Survival Benefits as 1st-line Treatment for Advanced Nasopharyngeal Carcinoma and Esophageal Squamous Cell Carcinoma Patients

• Long-term OS follow-up analysis of JUPITER-02 demonstrates significantly better and clinically meaningful improvement with toripalimab plus chemotherapy as 1^st-line treatment for R/M NPC, achieving mOS of 64.8 months and a 5-year OS rate of 52.3%.
• Torpalimab plus chemotherapy has been approved in over 40 countries, representing the new standard of care for the 1^st line treatment of R/M NPC.
• The final OS analysis of JUPITER-06 confirms the sustained survival benefit with toripalimab plus chemotherapy in advanced ESCC, showing a mOS of 17.7 months and a 3-year OS rate of 29.7%.
• Results from JUPITER-02 and JUPITER-06 were orally presented at ESMO Asia 2025.

SHANGHAI, Dec. 05, 2025 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced new and promising long-term survival results from JUPITER-02 (NCT03581786) and JUPITER-06 (NCT03829969) at the European Society for Medical Oncology (ESMO) ASIA Congress 2025. JUPITER-02 and JUPITER-06 evaluated toripalimab, an anti-PD-1 antibody developed by Junshi Biosciences, in combination with chemotherapy as first-line treatment for recurrent or metastatic (R/M) nasopharyngeal carcinoma (NPC) in JUPITER-02 and advanced or metastatic esophageal squamous cell carcinoma (ESCC) in JUPITER-06.

Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences and TopAlliance Biosciences, said: "At ESMO ASIA, we were excited to share the latest long-term survival follow-up data from the Phase 3 JUPITER-02 and JUPITER-06 trials. These remarkable results set new records for the longest survival benefit achieved with immuno-oncology (I-O) therapy in certain NPC and ESCC populations, further cementing toripalimab's global leadership in immunotherapy for advanced NPC and ESCC. Its so encouraging to see toripalimab now approved in over 40 countries and regions worldwide, giving more patients access to the new standard of care. We extend our deepest gratitude to the patients, their families, investigators and the R&D teams who made these landmark studies possible."

JUPITER-02: Study Design and Long-term Overall Survival Follow-up Analysis

JUPITER-02, the first global multicenter, double-blind, randomized Phase 3 trial in immunotherapy for NPC, has reported breakthrough results at multiple international congresses. Its interim and final overall survival (OS) analyses were published in Nature Medicine and the Journal of the American Medical Association (JAMA), respectively, making it the first NPC immunotherapy study featured in JAMA. The JUPITER-02 5-year OS follow-up data was presented at the ESMO Asia 2025, and it demonstrated sustained clinical benefits of toripalimab plus chemotherapy in R/M NPC.

The JUPITER-02 trial enrolled 289 chemotherapy-naïve patients with R/M NPC, randomizing them 1:1 to receive either toripalimab 240 mg (n=146) or placebo (n=143) combined with gemcitabine/cisplatin (GP) chemotherapy every 3 weeks (Q3W) for 6 cycles, followed by toripalimab or placebo monotherapy (Q3W) until disease progression, unacceptable toxicity, or 2-year treatment completion. Stratification factors included baseline ECOG status (0 vs. 1) and disease extent (recurrent vs. primary metastatic). The primary endpoint was Blinded Independent Review Committee (BIRC)-assessed progression-free survival (PFS) per RECIST v1.1 in the intent-to-treat (ITT) population. The secondary endpoints included OS (key secondary), investigator-assessed PFS, objective response rate (ORR), safety, etc.

By the data cut-off date, June 24, 2025, the toripalimab arm had demonstrated consistently significant survival improvements with the final OS analysis. Patients on toripalimab achieved a median OS (mOS) of 64.8 months compared to the 33.7 months seen with placebo. This 31.1-month extension in median survival also meant a 39% reduction in death risk (HR=0.62; 95%CI: 0.45-0.85; p=0.0027), with a 5-year OS rate of 52.3% vs. 33.9%. PD-L1 expression subgroup analyses revealed consistent OS improvements regardless of PD-L1 status.

As the first trial to confirm survival benefits with first-line immunotherapy for NPC, JUPITER-02 has now established a transformative global standard for R/M NPC treatment. Toripalimab plus GP chemotherapy is now approved in over 40 countries and endorsed by 3 major international guidelines (CSCO, NCCN, and ESMO), establishing a new benchmark for first-line R/M NPC therapy worldwide.

JUPITER-06: Study Design and Final Analysis

JUPITER-06 is a multicenter, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the efficacy and safety of toripalimab combined with TP (paclitaxel + cisplatin) chemotherapy versus placebo plus TP chemotherapy as first-line treatment for advanced or metastatic ESCC. The findings from JUPITER-06 have been presented at major international congresses and published in top-tier journals, including Cancer Cell and the Journal of Clinical Oncology (JCO). Results from the JUPITER-06 final analysis and biomarker evaluation were presented at the ESMO ASIA 2025.

The JUPITER-06 trial enrolled 514 systemic treatment-naïve patients with advanced or metastatic ESCC, randomly assigning 1:1 to receive either toripalimab 240 mg plus TP chemotherapy (n=257) or placebo plus TP chemotherapy (n=257) Q3W for 6 cycles, followed by toripalimab or placebo monotherapy Q3W. With stratification by baseline ECOG status (0 vs. 1) and prior radiotherapy history (yes vs. no), the study featured dual primary endpoints of PFS and OS assessed by BICR per RECIST v1.1, alongside secondary endpoints including investigator-assessed PFS, ORR, safety, etc.

By the data cut-off date, February 23, 2023 (median follow-up: 14.2 months), the pre-specified final OS analysis of JUPITER-06 demonstrated that according to the BICR, the toripalimab arm achieved a mOS of 17.7 months versus 12.9 months in the placebo arm, with a 28% reduction in death risk (HR=0.72, 95% CI: 0.580.88; P=0.002). The 2-year and 3-year OS rates are 39.1% vs. 27.1% and 29.7% vs. 19.9%, respectively.

Key subgroup analyses showed consistent OS benefits with toripalimab plus chemotherapy across all subgroups. Specifically, the PD-L1 expression subgroup analysis revealed improved OS in the toripalimab arm regardless of PD-L1 expression status.

Long-term follow-up revealed no new safety signals. Treatment-emergent adverse events (TEAEs) related to study treatment were comparable between the toripalimab arm and the placebo arm, with both groups showing a 97.3% incidence rate.

Furthermore, the investigators conducted translational research that, for the very first time, systematically identified predictive biomarkers for the "anti-PD-1 antibody + chemotherapy" combination. The results helped establish the world's first Esophageal Genomic Immunophenotype Classification (EGIC). This new framework prospectively pinpoints potential precision-targeted strategies for patients who respond poorly to chemo-immunotherapy, paving a practice-changing path for guiding more individualized clinical therapy and developing future combination approaches.

Up till now, toripalimab has gained approval for first-line treatment of advanced ESCC in China, EU, and multiple countries. Notably, it stands as Europe's first anti-PD-1 antibody approved for 1L advanced ESCC regardless of PD-L1 expression status.

About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune systems ability to attack and kill tumor cells.

More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.

In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI^®). Currently, there are twelve approved indications for toripalimab in the Chinese mainland:

1. unresectable or metastatic melanoma after failure of standard systemic therapy;
2. recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;
3. locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
4. in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;
5. in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);
6. in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);
7. in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;
8. in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC);
9. in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);
10. in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC);
11. in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients;
12. first-line treatment for unresectable or metastatic melanoma.

The first 10 indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. Toripalimab for the treatment of advanced NPC and ESCC was approved in Hong Kong SAR, China.

Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia, Singapore, United Arab Emirates, Kuwait, Pakistan, Canada and other countries and regions. In addition, toripalimab BLAs are under review in many countries or regions around the globe.

About Junshi Biosciences

Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the companys products have received approvals in China and international markets, one of which is toripalimab, Chinas first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 40 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI^®, and other novel therapies for the prevention and treatment of COVID-19.

With a mission of providing patients with world-class, trustworthy, affordable, and innovative drugs, Junshi Biosciences is In China, For Global. At present, the company boasts approximately 2,500 employees in the United States (Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com.

Junshi Biosciences Contact Information

IR Team:

Junshi Biosciences

info@junshipharma.com

+ 86 021-6105 8800

PR Team:

Junshi Biosciences

Zhi Li

zhi_li@junshipharma.com

+ 86 021-6105 8800

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