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▎The content team of WuXi AppTec reported that on November 26, according to the latest announcement on the official website of the National Medical Products Administration (NMPA) of China, Junshi Bio-developed PD-1 inhibitor Teriplizumab (Tuoyi) for the listing of new indications Approved
.
According to publicly available information, the new indications approved this time are: Teriprizumab combined with chemotherapy for advanced first-line recurrent and metastatic nasopharyngeal carcinoma (NPC) that has not received systemic treatment
.
This is also the fourth indication approved for teriprizumab in China after melanoma, nasopharyngeal cancer (third-line treatment) and urothelial cancer
.
Screenshot source: NMPA official website Teriplimumab is an anti-PD-1 monoclonal antibody independently developed by Junshi Bio
.
It was first approved for marketing by the NMPA in December 2018 for the treatment of unresectable or metastatic melanoma that has previously failed systemic treatment
.
In February 2021, the drug was approved by the NMPA for the treatment of recurrent/metastatic nasopharyngeal cancer patients who had previously failed second-line and above systemic treatments, becoming the world's first anti-PD-1 monoclonal antibody approved for the treatment of nasopharyngeal cancer
.
In April 2021, the drug was again approved by the NMPA for the treatment of locally advanced or metastatic urothelial cancer that has failed platinum-containing chemotherapy, including neoadjuvant or adjuvant chemotherapy, which has progressed within 12 months
.
According to a press release issued by Junshi Biotechnology, the approved new indication listing application for teriprizumab is for the first-line treatment of nasopharyngeal carcinoma, and the application is mainly based on the JUPITER-02 study
.
This is a randomized, double-blind, placebo-controlled, international multi-center phase 3 clinical study, with Professor Ruihua Xu from Sun Yat-sen University Cancer Hospital serving as the main investigator, aiming to compare teripril alone combined with gemcitabine/cisplatin with comfort The efficacy and safety of the drug combined with gemcitabine/cisplatin as the first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma confirmed by histology/cytology
.
At the American Society of Clinical Oncology (ASCO) annual meeting held in June this year, the JUPITER-02 study, as China's first indigenous innovative drug research, stood out from tens of thousands of submissions and was successfully selected as the "Blockbuster Research Abstract" of the plenary meeting ( LBA) is considered to be one of the most influential studies this year that is likely to change clinical practice
.
Public information shows that the JUPITER-02 study is also one of the world's largest phase 3 clinical studies of immune checkpoint inhibitors combined with chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma, enrolling a total of 289 patients
.
The results of the study showed that compared with chemotherapy alone, the first-line treatment of relapsed or metastatic nasopharyngeal carcinoma with teriprizumab combined with chemotherapy can achieve better progression-free survival (PFS) and higher objective response rate (ORR).
And longer duration of remission (DOR), and has good safety and tolerability
.
According to the data published in the journal Nature Medicine, as of the deadline of the interim analysis (May 30, 2020), compared with chemotherapy alone, the combination of teriprizumab and chemotherapy significantly improved PFS, and The PFS was 11.
7 (vs 8.
0 months), and nearly half (49%) of the patients had not progressed for more than a year, which greatly extended the patient’s progression-free survival time
.
The ORR was 77.
4% (vs 66.
4%), and the median DOR was 10.
0 (vs 5.
7 months), which was nearly doubled
.
▲Extended reading: Comment by Dr.
Yao Sheng from Junshi Biology | First in China! Why was the JUPITER-02 study selected for the ASCO annual meeting? Nasopharyngeal carcinoma is a malignant tumor that occurs in the mucosal epithelium of the nasopharyngeal area and is one of the common malignant tumors of the head and neck
.
In particular, the first-line treatment for advanced nasopharyngeal carcinoma used to be only platinum-containing chemotherapy as the standard treatment.
The prognosis of patients was poor and new treatment options were urgently needed
.
It is hoped that the new indications for the first-line treatment of nasopharyngeal carcinoma with teriprizumab will be approved, bringing new treatment options to more nasopharyngeal carcinoma patients
.
Reference materials: [1] The drug approval document pending information is released on November 26, 2021.
Retrieved Nov 26, 2021, from https:// html[2] Junshi Bio-Treplimumab combined with chemotherapy for the first-line treatment of nasopharyngeal cancer for the new indications for the marketing application has been accepted.
Retrieved Feb19, 2020, from https:// -1.
shtml[3]Ren C, Wei XL, Xu N, et al.
Clinical response and biomarker analysis of a phase II basket trial of toripalimab, a PD-1 mAb in combination with standard chemotherapy as a first-line treatment for patients with solid tumors[J].
Journal of Clinical Oncology, 2020, 38(15_suppl): e15083.
This article was compiled and edited by WuXi AppTec's content team based on public information.
Individuals are welcome to forward it to the circle of friends
.
For forwarding authorization, please leave a message on the WeChat official account of "Medical Guanlan" to contact us
.
For other cooperation needs, please contact wuxi_media@wuxiapptec.
com
.
Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
.
According to publicly available information, the new indications approved this time are: Teriprizumab combined with chemotherapy for advanced first-line recurrent and metastatic nasopharyngeal carcinoma (NPC) that has not received systemic treatment
.
This is also the fourth indication approved for teriprizumab in China after melanoma, nasopharyngeal cancer (third-line treatment) and urothelial cancer
.
Screenshot source: NMPA official website Teriplimumab is an anti-PD-1 monoclonal antibody independently developed by Junshi Bio
.
It was first approved for marketing by the NMPA in December 2018 for the treatment of unresectable or metastatic melanoma that has previously failed systemic treatment
.
In February 2021, the drug was approved by the NMPA for the treatment of recurrent/metastatic nasopharyngeal cancer patients who had previously failed second-line and above systemic treatments, becoming the world's first anti-PD-1 monoclonal antibody approved for the treatment of nasopharyngeal cancer
.
In April 2021, the drug was again approved by the NMPA for the treatment of locally advanced or metastatic urothelial cancer that has failed platinum-containing chemotherapy, including neoadjuvant or adjuvant chemotherapy, which has progressed within 12 months
.
According to a press release issued by Junshi Biotechnology, the approved new indication listing application for teriprizumab is for the first-line treatment of nasopharyngeal carcinoma, and the application is mainly based on the JUPITER-02 study
.
This is a randomized, double-blind, placebo-controlled, international multi-center phase 3 clinical study, with Professor Ruihua Xu from Sun Yat-sen University Cancer Hospital serving as the main investigator, aiming to compare teripril alone combined with gemcitabine/cisplatin with comfort The efficacy and safety of the drug combined with gemcitabine/cisplatin as the first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma confirmed by histology/cytology
.
At the American Society of Clinical Oncology (ASCO) annual meeting held in June this year, the JUPITER-02 study, as China's first indigenous innovative drug research, stood out from tens of thousands of submissions and was successfully selected as the "Blockbuster Research Abstract" of the plenary meeting ( LBA) is considered to be one of the most influential studies this year that is likely to change clinical practice
.
Public information shows that the JUPITER-02 study is also one of the world's largest phase 3 clinical studies of immune checkpoint inhibitors combined with chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma, enrolling a total of 289 patients
.
The results of the study showed that compared with chemotherapy alone, the first-line treatment of relapsed or metastatic nasopharyngeal carcinoma with teriprizumab combined with chemotherapy can achieve better progression-free survival (PFS) and higher objective response rate (ORR).
And longer duration of remission (DOR), and has good safety and tolerability
.
According to the data published in the journal Nature Medicine, as of the deadline of the interim analysis (May 30, 2020), compared with chemotherapy alone, the combination of teriprizumab and chemotherapy significantly improved PFS, and The PFS was 11.
7 (vs 8.
0 months), and nearly half (49%) of the patients had not progressed for more than a year, which greatly extended the patient’s progression-free survival time
.
The ORR was 77.
4% (vs 66.
4%), and the median DOR was 10.
0 (vs 5.
7 months), which was nearly doubled
.
▲Extended reading: Comment by Dr.
Yao Sheng from Junshi Biology | First in China! Why was the JUPITER-02 study selected for the ASCO annual meeting? Nasopharyngeal carcinoma is a malignant tumor that occurs in the mucosal epithelium of the nasopharyngeal area and is one of the common malignant tumors of the head and neck
.
In particular, the first-line treatment for advanced nasopharyngeal carcinoma used to be only platinum-containing chemotherapy as the standard treatment.
The prognosis of patients was poor and new treatment options were urgently needed
.
It is hoped that the new indications for the first-line treatment of nasopharyngeal carcinoma with teriprizumab will be approved, bringing new treatment options to more nasopharyngeal carcinoma patients
.
Reference materials: [1] The drug approval document pending information is released on November 26, 2021.
Retrieved Nov 26, 2021, from https:// html[2] Junshi Bio-Treplimumab combined with chemotherapy for the first-line treatment of nasopharyngeal cancer for the new indications for the marketing application has been accepted.
Retrieved Feb19, 2020, from https:// -1.
shtml[3]Ren C, Wei XL, Xu N, et al.
Clinical response and biomarker analysis of a phase II basket trial of toripalimab, a PD-1 mAb in combination with standard chemotherapy as a first-line treatment for patients with solid tumors[J].
Journal of Clinical Oncology, 2020, 38(15_suppl): e15083.
This article was compiled and edited by WuXi AppTec's content team based on public information.
Individuals are welcome to forward it to the circle of friends
.
For forwarding authorization, please leave a message on the WeChat official account of "Medical Guanlan" to contact us
.
For other cooperation needs, please contact wuxi_media@wuxiapptec.
com
.
Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress
.
This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.
This article is not a treatment recommendation either
.
If you need guidance on treatment plans, please go to a regular hospital for treatment
.
