Junshi Biosciences has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for toripalimab (LOQTORZI®) for two significant indications in nasopharyngeal carcinoma (NPC) and esophageal squamous cell carcinoma (ESCC). This approval marks a pivotal advancement in cancer treatment, providing new hope for patients with these challenging diseases.
Toripalimab Approved for NPC and ESCC
Toripalimab, a PD-1 inhibitor, is now approved for use in combination with cisplatin and gemcitabine as a first-line treatment for adult patients with recurrent, non-amenable to surgery or radiotherapy, or metastatic NPC. Additionally, it is approved in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic ESCC.
According to Junshi Biosciences, toripalimab stands as the first and only drug approved in the UK for NPC and the only first-line treatment for advanced or metastatic ESCC, regardless of PD-L1 status.
Clinical Evidence: JUPITER-02 and JUPITER-06 Trials
The MHRA approval for NPC is primarily based on the JUPITER-02 study (NCT03581786), a Phase 3, randomized, double-blind, placebo-controlled, multinational, multi-center clinical trial. The study demonstrated that toripalimab combined with chemotherapy significantly improved overall survival (OS) compared to chemotherapy alone. The results, presented at the 2021 ASCO meeting and published in JAMA, showed a 48% reduction in the risk of disease progression and a 37% reduction in the risk of death. The median progression-free survival (PFS) was extended by 13.2 months, from 8.2 months to 21.4 months. The five-year survival rate was reported as 52.0% at ASCO 2024.
The approval for ESCC is based on the JUPITER-06 study (NCT03829969), a Phase 3 trial evaluating toripalimab in combination with paclitaxel/cisplatin (TP) for first-line treatment of advanced ESCC. The findings, initially presented at the ESMO Congress 2021 and later published in Cancer Cell and Journal of Clinical Oncology, revealed that toripalimab plus chemotherapy led to superior PFS and OS. The median OS was prolonged by 6 months to 17 months, and the risk of disease progression or death was reduced by 42%. Significant survival benefits were observed irrespective of PD-L1 status.
Impact on Cancer Treatment
Nasopharyngeal carcinoma, a malignant tumor of the nasopharyngeal mucosal epithelium, affects over 120,000 individuals globally each year. Surgery is often not a viable option due to the tumor's location, making the combination of immunotherapy and chemotherapy a crucial first-line treatment, as recommended by the European Society of Medical Oncology (ESMO) guidelines.
Esophageal cancer, particularly ESCC, is a significant global health concern, with over 511,000 new cases and 445,000 deaths reported in 2022. The introduction of toripalimab offers a much-needed first-line treatment option for patients with this aggressive cancer.
Junshi Biosciences' Commitment
Dr. Jianjun ZOU, CEO of Junshi Biosciences, emphasized the importance of this approval, stating, "The approval of toripalimab by MHRA marks another significant milestone…not only making toripalimab the first and only drug in UK for the treatment of NPC, but also the only first-line treatment for ESCC, regardless of PD-L1 status." He further added the company's commitment to globalizing innovative Chinese biopharmaceuticals to address unmet medical needs.
About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody engineered to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and enhance receptor internalization. By blocking these interactions, toripalimab promotes the immune system’s ability to target and destroy tumor cells. Junshi Biosciences has conducted over forty company-sponsored clinical studies covering more than fifteen indications globally.
