TORCHLIGHT
Trial question
What is the role of addition of toripalimab to nab-paclitaxel in women with metastatic or recurrent triple-negative breast cancer?
Study design
Multi-center
Double blinded
RCT
Population
531 female patients.
Inclusion criteria: women with metastatic or recurrent triple-negative breast cancer.
Key exclusion criteria: CNS disease with active syndrome or untreated disease; autoimmune disease; prior allogeneic stem cell or solid organ transplantation; active hepatitis B or hepatitis C, positive for HIV antibody.
Interventions
N=353 toripalimab (first-line toripalimab and nab-paclitaxel).
N=178 placebo (matching placebo and nab-paclitaxel).
Primary outcome
Median progression-free survival in PD-L1-positive population
8.4 months
5.6 months
8.4 months
6.3 months
4.2 months
2.1 months
0.0 months
Toripalimab
Placebo
Significant
decrease ▼
Significant decrease in median progression-free survival in the PD-L1-positive population (8.4 months vs. 5.6 months; HR 0.65, 95% CI 0.47 to 0.91).
Secondary outcomes
Significant decrease in median overall survival (32.8 months vs. 19.5 months; HR 0.62, 95% CI 0.41 to 0.91).
Safety outcomes
No significant differences in treatment-emergent adverse events, ≥ grade 3 treatment-emergent adverse events, fatal adverse events.
Conclusion
In women with metastatic or recurrent triple-negative breast cancer, toripalimab was superior to placebo with respect to median progression-free survival in the PD-L1-positive population.
Reference
Zefei Jiang, Quchang Ouyang, Tao Sun et al. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: a randomized phase 3 trial. Nat Med. 2024 Jan;30(1):249-256.
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