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Association details:
| Biomarker: | PD-L1 expression |
|---|---|
| Cancer: | Triple Negative Breast Cancer |
| Drug: | Loqtorzi (toripalimab-tpzi) (PD1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
TORCHLIGHT: A randomized, double-blind, phase III trial of toripalimab versus placebo, in combination with nab-paclitaxel(nab-P) for patients with metastatic or recurrent triple-negative breast cancer (TNBC).
Published date:
05/25/2023
Excerpt:
Descriptive analysis of OS showed a trend towards improved OS in the PD-L1 positive (mOS 32.8 vs 19.5 months; HR = 0.615, 95%CI 0.414-0.914) and the ITT population (mOS 33.1 vs 23.5 months; HR = 0.691, 95% CI 0.513-0.932)….The addition of toripalimab to nab-P provided a significant improvement in PFS for PD-L1 positive metastatic or recurrent TNBC patients receiving first-line treatment with an acceptable safety profile.
Secondary therapy:
albumin-bound paclitaxel
DOI:
10.1200/JCO.2023.41.17_suppl.LBA1013
Trial ID:
Title:
Junshi Biosciences Announces Toripalimab in Combination with Chemotherapy for Treatment of Advanced Triple-negative Breast Cancer Met Primary Endpoint in Phase 3 Clinical Study
Published date:
02/20/2023
Excerpt:
Shanghai Junshi Biosciences...announced that the pre-specified interim analysis has been completed for a randomized, double-blind, placebo-controlled, multi-center phase III clinical study (“TORCHLIGHT Study”, NCT04085276) examining the company’s product toripalimab in combination with paclitaxel for injection (albumin-bound) in patients with an initial diagnosis of stage IV or recurrent/metastatic triple-negative breast cancer....The interim analysis of this study demonstrated that, compared with paclitaxel for injection (albumin-bound), toripalimab in combination with paclitaxel for injection (albumin-bound) in patients with initial diagnosis of stage IV or recurrent metastatic triple-negative breast cancer can significantly prolong the progression-free survival (PFS) of PD-L1 positive patients.
Secondary therapy:
albumin-bound paclitaxel
Trial ID:
Source:
Title:
Safety and Tolerability of Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Patients With Advanced Breast Cancer
Excerpt:
...Providing with tumor specimen (for testing the expression of PD -L1 and the infiltrating lymphocytes)...
Trial ID:
Source:
Title:
A phase I study of JS001, a humanized PD-1mAbin patients with advanced triple negative breast cancer.
Published date:
05/16/2018
Excerpt:
Phase I open-label study is designed to evaluate safety and tolerability of JS001 in advanced TNBC patients who are refractory to systemic therapy...50% subjects are PD-L1 positive (≥1% cutoff) in tumor biopsy, among whom a 40% DCR was observed.
DOI:
10.1200/JCO.2018.36.15_suppl.e15093
Trial ID:
