What makes a successful biomarker-driven trial?
The success of any biomarker-driven trials therefore certainly relies on an even closer collaboration among all involved in advancing cancer care, including clinical investigators, statisticians, sponsors, regulators, drug and assay developers, and patient advocates.
Is PD-L1 a biomarker for breast cancer?
PD-L1 expression as a biomarker in patients with breast cancer has had a complicated history and its incorporation into clinical practice remains challenging. At the time of writing, the FDA approval of ICIs in this setting is limited to advanced-stage TNBC 121.
Is PD-L1 a biomarker of eligibility for ICIS?
Most critically, the use of PD-L1 expression as a biomarker of eligibility for ICIs needs to take into account pharmacodynamic changes given evidence of the inducible nature of PD-L1 on both tumour cells and antigen-presenting cells by interferons and toll-like receptor ligands 183, 184.
Do secreted PD-L1 variants mediate resistance to neoadjuvant durvalumab?
Gong, B. et al. Secreted PD-L1 variants mediate resistance to PD-L1 blockade therapy in non-small cell lung cancer. J. Exp. Med. 216, 982–1000 (2019). Ahmed, F. S. et al. PD-L1 protein expression on both tumor cells and macrophages are associated with response to neoadjuvant durvalumab with chemotherapy in triple-negative breast cancer. Clin.
Management of T-Cell Lymphoma: In Quest of the Holy Grail