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Association details:
Biomarker:No biomarker
Cancer:Nasopharyngeal Carcinoma
Drug:Loqtorzi (toripalimab-tpzi) (PD1 inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Source:
Published date:
10/27/2023
Excerpt:
LOQTORZI is a programmed death receptor-1 (PD-1)- blocking antibody indicated...in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma
Secondary therapy:
cisplatin + gemcitabine
Evidence Level:
Sensitive: A1 - Approval
Title:

NMPA Approves Toripalimab in Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma after Failure of at Least Two Lines of Prior Systemic Therapy

Published date:
02/21/2021
Excerpt:
Junshi Biosciences…announced today that the National Medical Products Administration (NMPA) of China has granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Published date:
12/08/2023
Excerpt:
Cancer of the Nasopharynx: Preferred Regimens...Cisplatin/gemcitabine + toripalimab-tpzi…Subsequent-Line...Toripalimab-tpzi...
Secondary therapy:
cisplatin + gemcitabine
Evidence Level:
Sensitive: A2 - Guideline
Source:
Title:

Immunotherapy and Biomarker Testing in Recurrent and Metastatic Head and Neck Cancers: ASCO Guideline

Published date:
12/15/2022
Excerpt:
Immunotherapy and Biomarker Testing in Recurrent and Metastatic Head and Neck Cancers....Recommendation 4.1….Toripalimab, camrelizumab, or tislelizumab, with gemcitabine and cisplatin, should be offered as first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer
Secondary therapy:
cisplatin + gemcitabine
DOI:
10.1200/JCO.22.02328
Evidence Level:
Sensitive: B - Late Trials
Title:

Coherus Announces Positive Final Overall Survival Results of JUPITER-02 Phase 3 Trial Evaluating Toripalimab in Nasopharyngeal Carcinoma

Published date:
06/05/2023
Excerpt:
Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) announced the final overall survival (OS) results of the JUPITER-02 study...The final analysis of the JUPITER-02 clinical trial (NCT03581786) demonstrated a statistically significant and clinically meaningful improvement in OS for NPC patients who were treated with toripalimab in combination with gemcitabine and cisplatin chemotherapy, versus chemotherapy treatment alone.
Secondary therapy:
cisplatin + gemcitabine
Trial ID:
Evidence Level:
Sensitive: B - Late Trials
Title:

Coherus and Junshi Biosciences Announce FDA Acceptance of BLA Filing for Toripalimab for Treatment of Nasopharyngeal Carcinoma

Published date:
11/01/2021
Excerpt:
Coherus BioSciences...The FDA has granted Priority Review Designation for the toripalimab BLA and set a Prescription Drug User Fee Act ("PDUFA") action date for April 2022.
Evidence Level:
Sensitive: B - Late Trials
Title:

Junshi Biosciences and Coherus Announce U.S. FDA BTD Granted for Toripalimab for 1st Line NPC

Published date:
08/12/2021
Excerpt:
Shanghai Junshi Biosciences Co., Ltd...today announced that the United States Food and Drug Administration (“FDA”) has recently granted Breakthrough Therapy Designation (“BTD”) for toripalimab in combination with chemotherapy (gemcitabine and cisplatin) for the 1st line treatment of recurrent or metastatic nasopharyngeal carcinoma (“NPC”).
Secondary therapy:
cisplatin + gemcitabine
Evidence Level:
Sensitive: B - Late Trials
Title:

Junshi Biosciences Receives FDA Breakthrough Therapy Designation for Toripalimab for the Treatment of Nasopharyngeal Carcinoma

Published date:
09/10/2020
Excerpt:
Junshi Biosciences...announced today that the US Food and Drug Administration (FDA) has recently granted Breakthrough Therapy designation (BTD) to Toripalimab for the treatment of nasopharyngeal carcinoma.