DIPPER
Trial question
What is the role of camrelizumab in patients with locoregionally advanced nasopharyngeal carcinoma?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
24.0% female
76.0% male
N = 450
450 patients (110 female, 340 male).
Inclusion criteria: patients with locoregionally advanced nasopharyngeal carcinoma.
Key exclusion criteria: active autoimmune disease; ongoing systemic immunosuppressive therapy; active infection requiring systemic therapy; history of HIV; positivity for HBsAg with HBV DNA > 1×10³ copies/mL or 200 IU/mL; positivity for HCV antibodies.
Interventions
N=226 adjuvant camrelizumab (at a dose of 200 mg IV every 3 weeks for 12 cycles).
N=224 observation (standard therapy).
Primary outcome
Event-free survival at 3 years
86.9%
77.3%
86.9 %
65.2 %
43.5 %
21.7 %
0.0 %
Adjuvant
camrelizumab
Observation
Significant
increase ▲
NNT = 10
Significant increase in event-free survival at 3 years (86.9% vs. 77.3%; HR 1.79, 95% CI 1.12 to 2.78).
Secondary outcomes
Significant increase in distant metastasis-free survival at 3 years (92.4% vs. 84.5%; HR 1.85, 95% CI 0.08 to 3.62).
Significant increase in locoregional relapse-free survival at 3 years (92.8% vs. 87%; HR 1.87, 95% CI 1.01 to 3.57).
No significant difference in overall survival at 3 years (96.4% vs. 92.9%; HR 1.25, 95% CI 0.55 to 2.86).
Safety outcomes
No significant difference in neutropenia.
Significant differences in adverse events possibly related to study drug (91.7% vs. 0%), reactive capillary endothelial proliferation (87.8% vs. 0%).
Conclusion
In patients with locoregionally advanced nasopharyngeal carcinoma, adjuvant camrelizumab was superior to observation with respect to a event-free survival at 3 years.
Reference
Ye-Lin Liang, Xu Liu, Liang-Fang Shen et al. Adjuvant PD-1 Blockade With Camrelizumab for Nasopharyngeal Carcinoma: The DIPPER Randomized Clinical Trial. JAMA. 2025 Mar 13:e251132. Online ahead of print.
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