Nasopharyngeal carcinoma is endemic in Southern China and Southeast Asia. Patients with advanced disease have limited treatment options available and new therapies are sorely needed. According to the results of a study initially released at the American Society of Clinical Oncology Annual Meeting the incorporation of immunotherapy treatment significantly improves treatment.
Toripalimab is a type of immunotherapy known as a checkpoint inhibitor. Checkpoint inhibitors are a novel precision cancer immunotherapy that helps to restore the body’s immune system in fighting cancer by releasing checkpoints that cancer uses to shut down the immune system. PD-1 and PD-L1 are proteins that inhibit certain types of immune responses, allowing cancer cells to evade detection and attack by certain immune cells in the body. A checkpoint inhibitor can block the PD-1 and PD-L1 pathway and enhance the ability of the immune system to fight cancer. By blocking the binding of the PD-L1 ligand these drugs restore an immune cells’ ability to recognize and fight the cancer cells.2
The phase 3 JUPITER-02 clinical trial1 was designed to determine if the addition of a checkpoint inhibitor to standard chemotherapy treatment with with Gemzar, Cisplatin (GP) could improve treatment of patients with recurrent or metastatic nasopharyngeal carcinoma. The study was performed in 289 patients from mainland China, Taiwan, and Singapore.
The addition of Toripalimab to GP chemotherapy
- Improved the response rate from 67% to 71% and doubled the complete response rate.
- Improved cancer free survival from 8.2 to 21.4 months.
- Improved the proportion of patients surviving 2-years to 75.1% compared to 63.9%.
The trial resutls led to the US Food and Drug Administration approval of toripalimab-tpzi (Loqtorz) in combination with GP chemotherapy for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma. The FDA also approved Loqtorz as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. The overall response rate was 21% with a median response duration of 14.9 months when used as a single agent.
Immune-related side effects were more frequent with toripalimab, occurring in 53% of patients including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis with renal dysfunction, and skin reactions. Fatigue, hypothyroidism, and musculoskeletal pain were also reported.
The authors of the report concluded that “Treatment advances for late-stage nasopharyngeal carcinoma have lagged behind those of other cancers,” Julie R Gralow, MD, FACP, FASCO, chief medical officer and executive vice president of ASCO, commented in a press release about the trial.5 “Findings from the JUPITER-02 study offer new hope for patients with advanced disease, changing how we care for them.”
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References
- Xu R-H, Mai H-Q, Chen Q-Y, et al. JUPITER-02: the randomized, double-blind phase 3 study of toripalimab or placebo plus cisplatin and gemcitabine as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC). J Clin Oncol. 2021;39(suppl 15; abstr LBA2).
- Anti-PD-1 monoclonal antibody candidate toripalimab. Coherus Biosciences website. Accessed June 2, 2021. https://bit.ly/3vQ5EZh
- NMPA approves toripalimab in patients with recurrent or metastatic nasopharyngeal carcinoma after failure of at least two lines of prior systemic therapy. News release. Junshi Biosciences. February 22, 2021. Accessed June 2, 2021. https://bit.ly/3yX8U6Z
- Wang F-H, Wei X-L, Feng J, et al. Efficacy, safety, and correlative biomarkers of toripalimab in previously treated recurrent or metastatic nasopharyngeal carcinoma: a phase II clinical trial (POLARIS-02). J Clin Oncol. 2021;39(7):704-712. doi:10.1200/JCO.20.02712
- Addition of immunotherapy to standard of care first-line regimen delays disease progression in advanced nasopharyngeal carcinoma. News release. ASCO. June 3, 2021. Accessed June 3, 2021. https://bit.ly/3peKykR
- Mai H-Q, Chen Q-Y, Chen D, et al. Final progression-free survival analysis of JUPITER-02, a randomized, double-blind, phase 3 study of toripalimab or placebo plus gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma. Presented at AACR 2022; April 8-13, 2022. Abstract CT226/5.
