First-line treatment of nasopharyngeal cancer! Regener biological PD-1 monoantial phase 3 clinical reached the main research endpoint.

The Ripley monoantigen injection is an anti-PD-1 tumor immunotherapy approved in China as the first adaptive treatment for non-removable or metastasis melanoma that has failed to receive systemic treatment in the past.
Since its clinical development began in 2016,
Ripley has conducted more than 30 clinical studies around the world, including monopharmic and combination therapies, covering a wide range of adaptations such as nasopharyngeal cancer, urethra skin cancer, lung cancer, stomach cancer, esophageal cancer, liver cancer, breast cancer, kidney cancer, and more.
April 2020, the listing application for the treatment of relapsed/metastatic nasopharyngeal cancer, which had previously failed to receive second-line and above system treatment, was accepted by the NMPA.
May, a new adaptation application for the drug to treat local progressions or metastatic urethra cancer that had been systematically treated in the past was accepted by the NMPA.
of the above two adaptations were included in the NMPA's priority review in July.
September, the drug's adaptive treatment for nasopharyngeal cancer was recognized as a breakthrough fdable by the FDA.
The JUPITER-02 study, a randomized, double-blind, placebo-controlled, international multi-center Phase 3 clinical study, aims to compare triplidanant injections with Gisithamin/Shunplain, and placebo with Gisithamin/Shunplain, as a histologically/cytologically proven first-line treatment of patients with reciprocity or metastatic nasopharyngeal cancer, led by Professor Xu Ruihua of Sun Yat-sen University-affiliated Oncology Hospital.
study actually included 289 patients in the group, mainly ends with progress-free survival (PFS) assessed by the Independent Review Board (IRC), and secondary study endpoints include PFS, total lifetime (OS), objective mitigation rate (ORR), efficacy duration (DOR), disease control rate (DCR), etc.
According to the trial, during chemotherapy, subjects were randomly given Terripri monoantigen injections in combination with gisectabin and cisplatin (group A) or placebo combined with gisithamin and cisplatin chemotherapy (group B), Every 3 weeks (Q3W), chemotherapy will continue until the patient develops disease progress, or is insulated with toxic reactions, or does not follow, or withdraws consent, or has reached a maximum of 6 cycles of treatment time, whichever occurs earliest during chemotherapy.
Patients randomly assigned to Group A or Group B will continue to use Ripley monoantigen injections or placebos as maintenance therapy every 3 weeks until there is an intoestable toxic reaction, or disease progression, or withdrawal of consent, or the researcher determines that they need to withdraw from treatment or have reached a maximum of 2 years of treatment.
Based on the results of the mid-term analysis of JUPITER-02, the Independent Data Monitoring Board (IDMC) determined that the main study endpoint reached the predetermed optimal limit of the program, and the results showed that Thetripri single anti-injection combined with Gisithamin/shunplatin first-line treatment for patients with relapse or metastatic nasopharyngeal cancer, compared to the placebo/cisplatin standard first-line treatment, can significantly prolong the patient's non-progression survival.
nasopharyngeal cancer is a malignant tumor that occurs in the epitheliosis of the mucous membrane of the nasopharyngeal part, and mostly occurs in the top and side walls of the nasopharyngeal, especially the pharynx.
public data show that in 2018, nearly 130,000 new cases of nasopharyngeal cancer were confirmed worldwide, and new cases were relatively concentrated in Asia, accounting for 84.6% of new cases worldwide.
for patients with relapsed nasopharyngeal cancer or metastatic diseases, the total five-year survival rate of patients with general advanced disease was less than 10%, despite standard first-line chemotherapy programmes.
studies have shown that EBV, which is closely related to nasopharyngeal cancer, induces cancer cells to express high levels of PD-L1, while EBV antigens contribute to immune escape, suggesting that anti-PD-1 monoantigens have potential therapeutic effects in relapsed or metastatic nasopharyngeal cancer.
juPITER-02 study is expected to lead to new treatment options for patients with nasopharyngeal cancer.
source: Medical Mission Hills.