High quality clinical trials at Sun Yat-sen University Cancer Center lay the foundations for FDA approval of China's original PD-1 monoclonal antibody

November 02, 2023

On October 27, 2023, the Food and Drug Administration approved toripalimab-tpzi (LOQTORZ) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC).

The efficacy of LOQTORZ was evaluated in the JUPITER-02 trial, a pivotal study led by Prof. Ruihua Xu, President of Sun Yat-sen University Cancer Center, and conducted by his dedicated research team. In this double-blind, placebo-controlled trial, toripalimab combined with chemotherapy demonstrated remarkable results, providing new hope for patients with NPC. Notably, during the FDA inspection, experts commended the trial for its transparent process and stringent quality control measures. They found the experimental data to be objective and reliable, and the trial's implementation fully aligned with the protocol requirements. Every member of the research team exhibited conscientiousness and rigorous work ethic, ensuring the highest quality in clinical trials. These factors collectively lay a robust foundation for the successful outcome of the trial.

NPC patients have long faced limited treatment options, with surgery rarely a viable choice due to the tumor's location. Current treatments primarily involve radiation and chemotherapy. LOQTORZ represents a significant breakthrough as the first FDA-approved treatment for NPC patients, marking a crucial milestone in the field of oncology.

Prof. Ruihua Xu, who spearheaded the JUPITER-02 trial, expressed his enthusiasm, stating, "The impressive results from JUPITER-02 have provided conclusive evidence that establishes toripalimab, in combination with chemotherapy or as monotherapy, as the standard therapy for advanced NPC."

This achievement is one of the milestones of rigorous research by countless oncology experts and the unwavering commitment of patients and research teams involved in toripalimab studies. The hope is that this groundbreaking therapy will bridge the treatment gap for international NPC patients, offering a renewed sense of hope for better survival.

LOQTORZ is expected to become available in the United States in Q1 2024, with the potential to transform the treatment landscape for NPC patients worldwide.

For more information from the FDA:

Written by the Huiwen Zhai and Shuang Liao, Sun Yat-sen University Cancer Center

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