According to study results presented during the annual meeting of the American Society of Clinical Oncology (ASCO), held June 4 – 8, 2021, adding toripalimab (Shanghai Junshi Bioscience Co), a recombinant, humanized programmed death receptor-1 (PD-1) antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2), to standard first-line chemotherapy, significantly delayed disease progression for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC).

The international Phase III JUPITER-02 study may represent a paradigm shift in the care of these patients, for whom there are currently few treatment options.

ASCOStudy design
In the phase III trial, 289 patients with recurrent or metastatic nasopharyngeal carcinoma, who had not received previous chemotherapy, were randomized 1:1 to receive toripalimab (146 patients) or placebo (143). Patients in both groups also received gemcitabine/cisplatin chemotherapy. The study’s primary endpoint was PFS in all study patients. Secondary endpoints included overall response rate, duration of response, and overall survival (OS).

Study findings
Nasopharyngeal carcinoma, a type of head and neck cancer that starts in the nasopharynx, represents a significant global health problem. The cancer is particularly prevalent in East and Southeast Asia, which accounted for more than 70% of the approximate 129,000 new diagnoses worldwide in 2018.[1][2] Platinum-based therapy is currently the standard first-line treatment for recurrent or metastatic Nasopharyngeal carcinoma, however, the duration of response is, on average, less than six months.[3]

The JUPITER-02 trial demonstrated that the addition of the immunotherapy toripalimab to standard first-line chemotherapy lengthened the time to disease progression compared with placebo, with a median of 11.7 months versus. 8.0 months, respectively. At 1 year, 49% of patients who received toripalimab had not experienced disease progression, compared to 28% of those who received placebo.

Advertisement #3

Adverse events
Serious adverse events (AEs) grade 3 or greater were similar for both groups — 89.0% for toripalimab versus 89.5% for placebo, with discontinuation of treatment in 7.5% of immunotherapy patients, compared to 4.9% that took placebo. Fatal AEs were similar between the two arms, 2.7%, and 2.8%, respectively.

Immune-related AEs were more common with toripalimab, 39.7%, compared with placebo,18.9%. Immune-related AEs grade 3 or greater were also more common with toripalimab (7.5%) than with placebo (0.7%).

Toripalimab is an immune therapy known as a checkpoint inhibitor that works by blocking programmed cell death protein 1 (PD-1) found on the surface of immune cells, allowing the immune system to continue working properly.

“Nasopharyngeal carcinoma is challenging as it is typically diagnosed in an advanced stage when current therapy options are extremely limited. The extended response in patients that received with toripalimab marks a significant advance for the treatment of this disease,” noted Rui-hua Xu, MD, Ph.D., of the department of medical oncology at Sun Yat-sen University Cancer Center in Guangzhou, China.

Clinical trials
Phase III Study of Comparing TORIPALIMAB INJECTION Versus Placebo Combined With Chemotherapy for Recurrent or Metastatic Nasophapyngeal Cancer – NCT03581786

Highlights of prescribing information
Gemcitabine (Gemzar®; Eli Lilly and Company) [Prescription Information]

Cisplatin (Platinol®, Platinol-AQ®; Bristol-Myers Squibb Company)  [Perscription Information]

[1] Bray F, Ferlay J, Soerjomataram I, et al: Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 68:394-424, 2018.
[2] Chen YP, Chan ATC, Le QT, Blanchard P, Sun Y, Ma J. Nasopharyngeal carcinoma. Lancet. 2019 Jul 6;394(10192):64-80. doi: 10.1016/S0140-6736(19)30956-0. Epub 2019 Jun 6. PMID: 31178151.
[3] Zhang L, Huang Y, Hong S, Yang Y, Yu G, Jia J, Peng P, Wu X, Lin Q, Xi X, Peng J, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016 Oct 15;388(10054):1883-1892. doi: 10.1016/S0140-6736(16)31388-5. Epub 2016 Aug 23. Erratum in: Lancet. 2016 Oct 15;388(10054):1882. PMID: 27567279.

Featured image: Doctor talking to a patient. Photo Courtesy: © 2016 – 2021 Fotolia/Adobe. Used with permission.

Advertisement #5