Domestic PD-1 therapy! Junshi Bio-Treplimumab (Tuoyi®) has been successful in the first-line treatment of stage 3 esophageal cancer!

News on April 23, 2021 // --Junshi Biosciences recently announced that its self-developed anti-PD-1 monoclonal antibody drug teriprizumab injection (Tuoyi®, toripalimab) combined with chemotherapy as the first-line treatment of advanced esophageal squamous cell carcinoma (ESCC) The randomized, double-blind, placebo-controlled, multi-center phase 3 clinical study (JUPITER-06 study, clinicaltrials.
gov identifier: NCT03829969) in the interim analysis was determined by the Independent Data Monitoring Committee (IDMC) to determine 2 primary endpoints Both the progression-free survival (PFS) and overall survival (OS) reached the superiority threshold of the program
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Junshi Bio will communicate with the regulatory authorities in the near future to submit the listing application
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Esophageal cancer is a malignant tumor that originates in the epithelium of the esophageal mucosa and is one of the most common tumors in the world
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Relevant data show that in 2020, esophageal cancer is the seventh most common malignant tumor and the sixth leading cause of cancer death in the world
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Among them, China's new cases of esophageal cancer about 32 million and about 300,000 deaths, morbidity and mortality rates were ranked all malignant tumors fifth and fourth place in
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Esophageal squamous cell carcinoma and adenocarcinoma are the two main histological subtypes of esophageal cancer.
Among them, esophageal squamous cell carcinoma is the main subtype in Chinese patients, accounting for about 90% of the overall incidence
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For patients with advanced esophageal squamous cell carcinoma, the current standard first-line chemotherapy is platinum-based chemotherapy, but the 5-year overall survival rate is still less than 20%
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Domestic and foreign studies have shown that anti-PD-1 monoclonal antibody combined with chemotherapy is expected to become the new first-line standard treatment for esophageal squamous cell carcinoma
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Esophageal cancer (picture source: medindia.
net)

The JUPITER-06 study (NCT03829969) is a randomized, double-blind, placebo-controlled, multicenter phase 3 clinical study, which aims to compare the effects of teriprizumab combined with paclitaxel/cisplatin with placebo combined with paclitaxel/cisplatin.
Efficacy and safety of first-line treatment for advanced esophageal squamous cell carcinoma
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According to the results of the mid-term analysis of the JUPITER-06 study, the Independent Data Monitoring Committee (IDMC) determined that the two main research endpoints of the study, Progression-Free Survival (PFS) and Overall Survival (OS), both reached the superiority threshold preset by the protocol.
It shows that teriprizumab injection combined with paclitaxel/cisplatin first-line treatment of patients with advanced esophageal squamous cell carcinoma, compared with standard first-line treatment of paclitaxel/cisplatin, can significantly prolong the progression-free survival and overall survival of patients
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Regarding detailed research data, Junshi Bio will be announced at a recent international academic conference
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Teriplizumab is a recombinant humanized anti-PD-1 monoclonal antibody injection with a unique dual mechanism of action
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The drug belongs to PD-(L)1 tumor immunotherapy.
This type of therapy aims to use the body's own immune system to fight cancer, block the PD-1/PD-L1 signaling pathway to kill cancer cells, and can treat many types of tumors.
Potential
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Globally, there are currently 12 PD-(L)1 therapies approved, of which 8 have been approved in China
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In terms of immunotherapy for esophageal cancer, two PD-1 therapies have been approved, namely Merck’s anti-PD-1 therapy Keytruda (Pembrolizumab, pembrolizumab) and Bristol-Myers Squibb anti-PD- 1 Therapy Opdivo (Odivo, Navulimab)
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Among them, Keytruda is suitable for the treatment of recurrent, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) where tumors express PD-L1 (combined with a positive score [CPS] ≥ 10), and the disease has progressed after receiving one or more systemic therapies Patient
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Opdivo is suitable for the treatment of patients with unresectable advanced or recurrent ESCC who have progressed after chemotherapy, regardless of their PD-L1 status
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In China, Keytruda was approved by the National Food and Drug Administration in June 2020 as a single-agent therapy for the treatment of locally advanced or metastatic tumors that have failed previous systemic therapies and express PD-L1 (combined positive score [CPS] ≥ 10) Patients with esophageal squamous cell carcinoma (ESCC)
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This new indication is fully approved based on the overall survival (OS) results of the global phase III KEYNOTE-181 trial, including expanded data in Chinese patients
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Original source: Junshi Biology,