|The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Adding toripalimab to chemotherapy with gemcitabine plus cisplatin (GP) improved progression-free survival (PFS) in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) in the phase 3 JUPITER-02 trial.1
These results were presented as a late-breaking abstract at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting by Rui-Hua Xu, MD, PhD, of Sun Yat-Sen University Cancer Center in Guangzhou, China, and colleagues.
“Nasopharyngeal carcinoma is challenging, as it is typically diagnosed in an advanced stage when current therapy options are extremely limited,” Dr Xu said in a press release.2
The JUPITER-02 trial (ClinicalTrials.gov Identifier: NCT03581786) was designed to evaluate the efficacy and safety of toripalimab plus GP, the current standard of care, in patients with recurrent or metastatic NPC.
A total of 289 patients were randomized 1:1 to receive either toripalimab plus GP (n = 146) or placebo plus GP (n = 143) for up to 6 cycles. This was followed by maintenance with toripalimab monotherapy or placebo every 3 weeks.
PFS was significantly better in the toripalimab arm than in the placebo arm. The median PFS was 11.7 months and 8.0 months, respectively (hazard ratio [HR] 0.52; 95% CI, 0.36-0.74; P= .0003). The 1-year PFS rate was 49.4% and 27.9%, respectively.
Although the overall survival (OS) data are not yet mature, there was a 40% reduction in the risk of death in the toripalimab arm.
The median OS was not reached in either arm (HR, 0.603; 95% CI, 0.364-0.997; P =.0462). The 1-year OS rate was 91.6% in the toripalimab arm and 77.8% in the placebo arm. The 2-year OS rate was 77.8% and 63.3%, respectively.
Overall, no new safety signals were identified with the addition of toripalimab to GP. The incidence of grade 3 or higher adverse events (AEs) was similar between the treatment arms — 89.0% with toripalimab and 89.5% with placebo.
The most common AEs were hematologic toxicities and were mainly attributed to the GP regimen. Immune-related AEs of any grade were more frequent in the toripalimab arm (39.7% vs 18.9%), as were grade 3 or higher immune-related AEs (7.5% vs 0.7%).
The results of this study support the use of toripalimab with GP as the new standard care for this patient population, according to Dr Xu and colleagues.
“Treatment advances for late-stage nasopharyngeal carcinoma have lagged behind those of other cancers,” ASCO Chief Medical Officer and Executive Vice President Julie R. Gralow, MD, said in a press release.2 “Findings from the JUPITER-02 study offer new hope for patients with advanced disease, changing how we care for them.”
Disclosure: This research was supported by Shanghai Junshi Biosciences. One of the study authors disclosed affiliations with pharmaceutical companies. Please see the original reference for a full list of disclosures.
Read more of Cancer Therapy Advisor’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.
- Xu RH, Mai HQ, Chen QY, et al. JUPITER-02: Randomized, double-blind, phase III study of toripalimab or placebo plus gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC). J Clin Oncol. 2021;39:(suppl 15; abstr LBA2). doi:10.1200/JCO.2021.39.15_suppl.LBA2
- Addition of Immunotherapy to Standard of Care First-Line Regimen Delays Disease Progression in Advanced Nasopharyngeal Carcinoma [press release]. Alexandria, VA: American Society of Clinical Oncology; June 3, 2021.