According to the World Health Organization, the number of new cases of nasopharyngeal cancer confirmed worldwide in 2020 exceeded 130,000. For relapsed or metastatic nasopharyngeal carcinoma, the current treatment is limited, and the first-line standard treatment regimen is gemcitabine plus cisplatin chemotherapy, and the overall survival of patients needs to be improved urgently. With the development of new anti-tumor drugs and the emergence of new clinical treatment technologies, the treatment pattern of nasopharyngeal carcinoma has ushered in a transformative breakthrough.
The national listing of the first-line indications for Tuoyi nasopharyngeal carcinoma will be launched
On January 22, the national listing meeting of the first-line indications for nasopharyngeal carcinoma of CSCO-Junshi Biotuoyi (Triprimumab injection) was held in Guangzhou. Many experts and scholars conducted in-depth discussions on the achievements and prospects of emerging immunotherapy in the field of nasopharyngeal carcinoma.
The "China Plan" reshapes the standard of treatment for NASOPHARY
Triprimumab (trade name: Tuoyi) is a recombinant humanized anti-PD-1 monoclonal antibody injection independently developed by Junshi Bio, which is the world's first immune checkpoint inhibitor approved for the treatment of nasopharyngeal carcinoma, achieving a breakthrough of zero immunotherapy in the field of nasopharyngeal cancer treatment. The first-line indication for nasopharyngeal carcinoma on the market is the first-line treatment of triprimumab combined with cisplatin and gemcitabine for patients with locally recurrent or metastatic nasopharyngeal cancer, which is also the second indication for the drug to be approved for marketing in the field of nasopharyngeal cancer.
Professor Xu Ruihua of the Cancer Prevention and Control Center of Sun Yat-sen University delivered a speech
"Nasopharyngeal carcinoma is a relatively special type of tumor, and globally, the mainland is an absolutely high incidence area. In this field, the current level of diagnosis and treatment and research in the mainland is at the forefront of the world, and it is also the unshirkable responsibility of our researchers to let Chinese patients take the lead in benefiting from innovative therapies. Professor Xu Ruihua of the Cancer Prevention and Control Center of Sun Yat-sen University said.
The approval of the first-line indications for turprimumab nasopharyngeal carcinoma is based on the JUPITER-02 study, which is a randomized, double-blind, placebo-controlled, international multicenter immunotherapy combined with standard chemotherapy first-line treatment of recurrent/metastatic nasopharyngeal carcinoma phase III clinical study, with Professor Xu Ruihua as the main investigator, registered in China and the United States at the same time, including a total of 289 patients with recurrent/metastatic nasopharyngeal cancer who have not received chemotherapy.
"At present, the first-line treatment methods for patients with local recurrent or metastatic nasopharyngeal carcinoma in clinical application are not ideal, so it is urgent to explore more effective treatment options." At the meeting, Professor Mai Haiqiang of the Center for Cancer Prevention and Treatment of Sun Yat-sen University focused on the highlights of the JUPITER-02 study: Through the JUPITER-02 study, we were pleased to see that compared with chemotherapy alone, the first-line treatment of treprimumab combined with gemcitabine and cisplatin (GP chemotherapy) for relapsed/metastatic nasopharyngeal carcinoma can achieve better progression-free survival (PFS), higher objective response rate (ORR) and longer remission duration (DoR), and the safety is manageable. ”
Professor Mai Haiqiang of the Cancer Prevention and Treatment Center of Sun Yat-sen University interprets the highlights of the JUPITER-02 research
Professor Mak Haiqiang specifically analyzed that the results of the study showed that the main research endpoint PFS (BIRC assessment) of the triprimumab group reached 11.7 months, which was 3.7 months longer than that of the chemotherapy group, and the risk of death or disease progression was 48% lower than that of the chemotherapy group; the total survival time (OS) data of the two groups were not yet mature, but the OS of the triprimumab group was significantly prolonged, and the risk of death was reduced by 40%.
It is worth mentioning that this research has been highly recognized by the international academic community for many times, and has been selected as a "blockbuster research abstract" (#LBA2) as a plenary meeting of the American Society of Clinical Oncology Annual Meeting (ASCO 2021), and has been honored on the cover of nature medicine (impact factor: 53.440), which is also the first time in the 26 years since the founding of nature medicine to recommend Chinese innovative drug research on the cover.
"Triprimumab rewrote the 2021 edition of the CSCO Guidelines for the Diagnosis and Treatment of Nasopharyngeal Cancer, and has been recommended by experts in first-line, second-line and above, third-line and above treatments. At present, multiple studies of triprimumab are in full swing. In the field of nasopharyngeal cancer treatment, 'China Power' has changed the world and reshaped the standard of nasopharyngeal cancer treatment, and we expect triprprimumab to make more good sounds in the field of nasopharyngeal cancer. Professor Mak Said.
The inclusion of triprimumab in Medicare benefits more patients
Dr. Yao Sheng, senior vice president of Junshi Biologics, said at the listing meeting that Junshi Bio is working hard to make the "China Solution" benefit patients around the world. Based on the excellent results of treprimumab in the POLARIS-02 and JUPITER-02 studies, the U.S. Food and Drug Administration (FDA) has awarded the drug two breakthrough therapy designations aimed at accelerating its development and review process. At present, Junshi Bio has submitted to the FDA the application for the licensing of biological products (BLA) of triprimumab combined with gemcitabine/cisplatin as the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal cancer and the single drug for the second-line and above treatment after platinum-containing treatment of relapsed or metastatic nasopharyngeal cancer, and has been accepted, and triprimumab is also the first domestic anti-PD-1 monoclonal antibody to submit a listing application to the FDA.
It is reported that on January 1, 2022, the new version of the national medical insurance drug list was implemented, and triprprimumab became the only anti-PD-1 monoclonal antibody used in the directory for the treatment of nasopharyngeal carcinoma. After the inclusion of medical insurance, the monthly out-of-pocket cost of patients will drop to less than 2,000 yuan, which is expected to allow more patients to benefit from innovative therapies.
Li Cong, co-CEO of Junshi Biotech, said: "In the field of nasopharyngeal cancer, triplelimab has successively achieved two indications on the market, of which the backline treatment indications have been included in medical insurance through the 2021 national talks, which will surely meet the needs of more Chinese nasopharyngeal cancer patients. At the same time, we are also actively promoting the research and development and commercialization of innovative drugs such as tereplizumab at the global level, promoting China's local innovative drugs to the world and benefiting patients around the world. ”
[Reporter] Yan Huifang
【Author】 Yan Huifang
Healthy living circle