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Association details:
| Biomarker: | PD-L1 expression |
|---|---|
| Cancer: | Triple Negative Breast Cancer |
| Drug: | BNT327 (PD-L1 inhibitor, VEGF-A inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A phase Ib/II study of PM8002 injection plus nab-paclitaxel as first line therapy for unresectable, locally advanced or metastatic triple-negative breast cancer
Excerpt:
...All subjects should accept fresh tumor lesion biopsy during the screening period (bone biopsy, fine-needle biopsy and pleural and ascites samples are not accepted; subjects with only the only target lesion available for biopsy are not accepted), Obtain enough qualified tumor tissue samples for the analysis of biomarkers (including PD-L1 expression level) in the cohort; If the subject is unable to undergo biopsy, the tumor sample or unstained section (3-5μm ) for the corresponding biomarker analysis; If the subject is unable to provide a specimen that meets the above requirements due to special reasons, the subject can participate in the screening after evaluation and approval by the sponsor; 6. ...
Trial ID:
Source:
Title:
A Phase Ib/II Study to Assess the Safety and Efficacy of PM8002 (Anti-PD-L1 x VEGF-A Bispecific Antibody) in Combination with Nab-Paclitaxel for First Line Treatment of Locally Advanced or Metastatic Triple-Negative Breast Cancer
Published date:
12/02/2023
Excerpt:
Among 13 patients with PD-L1 combined positive scores (CPS) < 1, the best ORR and DCR were 69.2% (9/13) and 100.0% (13/13), respectively. Among 25 patients with PD-L1 CPS ≥1, the best ORR and DCR were 80.0% (20/25) and 96.0% (24/25), respectively. Among 9 patients with PD-L1 CPS ≥10, the best ORR and DCR were both 100.0% (9/9).... Here, we present results from a Phase Ib/II study of PM8002 in combination with nab-paclitaxel in patients with locally-advanced or metastatic triple-negative breast cancer (TNBC).
