Contents

Toripalimab

Toripalimab, sold under the brand name Loqtorzi, is a monoclonal antibody used for the treatment of melanoma and nasopharyngeal carcinoma.^[1][3] Toripalimab is a recombinant humanized programmed cell death protein 1 (PD-1) monoclonal antibody that acts as a checkpoint inhibitor.^[4]

In 2018, toripalimab was approved in China for the treatment of unresectable or metastatic melanoma that has failed previous systemic therapy.^[4] In October 2023, the US Food and Drug Administration (FDA) approved toripalimab for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma when used with cisplatin and gemcitabine.^[3][5]

Medical uses[edit]

Toripalimab is indicated in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma.^[1][3] It is also indicated as a single agent for adults with recurrent unresectable or metastatic nasopharyngeal carcinoma with disease progression on or after a platinum-containing chemotherapy.^[1][3]

History[edit]

Efficacy of toripalimab with cisplatin and gemcitabine was evaluated in JUPITER-02 (NCT03581786), a randomized, multicenter, single region, double-blind, placebo-controlled trial in 289 participants with metastatic or recurrent, locally advanced nasopharyngeal carcinoma who had not received previous systemic chemotherapy for recurrent or metastatic disease.^[3] Participants were randomized (1:1) to either toripalimab with cisplatin and gemcitabine, followed by toripalimab, or placebo with cisplatin and gemcitabine, followed by placebo.^[3]

Efficacy of toripalimab as a single agent was evaluated in POLARIS-02 (NCT02915432), an open-label, multicenter, single country, multicohort trial in 172 participants with unresectable or metastatic nasopharyngeal carcinoma who had received prior platinum-based chemotherapy or had disease progression within six months of completion of platinum-based chemotherapy administered as neoadjuvant, adjuvant, or definitive chemoradiation treatment for locally advanced disease.^[3] Participants received toripalimab until disease progression per RECIST v1.1 or unacceptable toxicity.^[3]

The FDA granted the application for toripalimab priority review, breakthrough therapy, and orphan drug designations.^[3]

References[edit]

^ ^{a b c d e f g h i} "FDA approves toripalimab-tpzi for nasopharyngeal carcinoma". U.S. Food and Drug Administration (FDA). 27 October 2023. Archived from the original on 2 November 2023. Retrieved 2 November 2023. This article incorporates text from this source, which is in the public domain.

External links[edit]

• Clinical trial number NCT03581786 for "The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer" at ClinicalTrials.gov
• Clinical trial number NCT02915432 for "The Study to Evaluate Toripalimab (JS001) in Patients With Advanced GC, ESCC, NPC, HNSCC" at ClinicalTrials.gov