The addition of a novel drug to the chemotherapies gemcitabine and cisplatin significantly improved a survival outcome in patients with a rare form of head and neck cancer, compared with chemotherapy alone.
First-line treatment with a new drug toripalimab combined with the chemotherapies gemcitabine and cisplatin was associated with superior progression-free survival in patients with recurrent or metastatic nasopharyngeal carcinoma, compared to chemotherapy alone.
The data, which were presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated that treatment with the study drug resulted in a median progression-free survival (time during and after treatment when the patient lives without disease progression) of 11.7 months compared to 8 months in those who received chemotherapy alone.
“From this first international trial, we can see that the addition of toripalimab to (gemcitabine and cisplatin) as a first-line treatment for nasopharyngeal carcinoma showed better (progression-free survival) and (overall survival) than (gemcitabine and cisplatin) alone. The combination was safe, and no new safety signals were found,” study author Dr. Rui-Hua Xu, of Sun Yat-Sen University Cancer Center in China, said in a virtual presentation on the data. “These results support the use of the toripalimab combination as a new standard of care in the first-line treatment of patients with recurrent or metastatic [disease].”
Nasopharyngeal carcinoma is quite rare in the United States, with estimates from the American Cancer Society indicating less than one case per 100,000 people each year. However, the disease is considered endemic in Southern China and Southeast Asia, according to Xu, who explained that the incidence of this cancer is three cases per 100,000 people in China. In fact, the American Cancer Society estimates that there are as many as 21 cases per 100,000 people in some parts of China.
Moreover, patients with recurrent or metastatic disease have limited therapeutic options available to them, and the current standard-of-care frontline treatment worldwide for this population is the chemotherapies gemcitabine and cisplatin.
In the global, double-blind, placebo-controlled phase 3 JUPITER-02 trial, investigators sought to examine toripalimab in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin with placebo in the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma.
To be eligible for enrollment, patients needed to be between 18 and 75 years of age and have primary or metastatic nasopharyngeal carcinoma or recurrent disease following curative-intent treatment. Patients also needed to be treatment naïve for recurrent or metastatic disease.
A total of 289 participants from mainland China, Taiwan, and Singapore were randomized to receive toripalimab plus the chemo combination every three weeks for six treatment cycles followed by toripalimab maintenance every three weeks (146 patients) or the chemo combo plus placebo every three weeks for six cycles followed by placebo maintenance every three weeks (143 patients).
Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, investigator decision, or a maximum of two years.
Measuring progression-free survival was the main goal of the study. Other goals included assessing objective response rate, duration of response, disease control rate, and overall survival.
Additional data from the trial showed that the one-year progression-free survival rates in the study drug and chemotherapy alone group were 49.4% and 27.9%, respectively.
Treatment with the toripalimab regimen resulted in a one-year overall survival rate of 91.6% compared with 87.1% in the chemotherapy alone group. The findings also showed that two-year overall survival data was greater in the group who received study drug (77.8% versus 63.3%, respectively).
All patients in each group experienced a side effect. The number of serious or severe side effects were also similar between the two groups — 89% in the toripalimab group and 89.5% in the chemotherapy alone group.
“The most common (side effects) were hematologic toxicity, which were mainly attributed to the (gemcitabine and cisplatin) chemotherapy regimen,” Xu noted. “The incidence of immune-related (side effects), such as hypothyroidism, were higher in the toripalimab arm; this was expected (with immunotherapy) and (proved to be) manageable.”
All severity immune-related side effects were reported in 39.7% of patients who received the toripalimab regimen versus 18.9% of those who received chemotherapy alone.
“Treatment advances for late-stage nasopharyngeal carcinoma have lagged behind those of other cancers,” said ASCO Executive Vice President Dr. Julie R Gralow in a news release. “Findings from the JUPITER-02 study offer new hope for patients with advanced disease, changing how we care for them.”
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