PD-L1 expression + CD8 positive

High Ki-67 index, and high CD8 cell count are strong predictors for pCR in HER2-positive breast cancer. Tumours with high Ki-67 index, high TILs and CD8 infiltration may represent a subgroup where standard therapies are adequate. Conversely, those with low TILs and CD8 infiltration may identify a subgroup where use of novel strategies, including those that increase CD8 infiltration could be applied.

P2, N=151, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Nov 2023 --> Apr 2024 | Trial primary completion date: Nov 2023 --> Apr 2024

KN046 was well tolerated and showed promising antitumor efficacy in advanced solid tumors, especially in patients with NPC. The combination of both CD8 and PD-L1 expression improved the prediction of KN046 response.

PD-L1 expression in tumor and inflammatory cells is found in a wide range of human tumor types. Higher rates of tumor infiltrating CD8 positive lymphocytes in PD-L1 positive than in PD-L1 negative cancers suggest that the antitumor immune response may trigger tumoral PD-L1 expression.

P2, N=161, Active, not recruiting, Novartis Pharmaceuticals | Recruiting --> Active, not recruiting

Profiling tumor and blood samples, we found that follicular helper CD4+ T cells (TFH) are among the best therapeutic targets of pembrolizumab correlating with progression-free survival...Finally, TFH and IgG directed against urothelium invasive Escherichia coli dictated clinical responses to pembrolizumab in three independent cohorts. The links between tumor infection and success of ICB immunomodulation should be prospectively assessed at a larger scale.

A notable reversal of CD8 T cell exclusion was observed in a melanoma patient who failed prior ipilimumab and nivo treatment. The data indicate the potential for broad utility of RP1 in a range of tumor types, including in patients with primary or acquired resistance to immune checkpoint blockade. Trial Registration NCT03767348

The clinical outcomes of unselected patients with BRAF-MT CRC were generally similar to those in previous studies. Based on the immune profile analysis, higher PD-L1 expression and CD8-positive cell infiltration were observed in BRAF-MT tumors with a good prognosis.

P2, N=161, Recruiting, Novartis Pharmaceuticals | Trial completion date: May 2023 --> Oct 2023 | Trial primary completion date: May 2023 --> Oct 2023

A particularly striking change was observed in a biopsy obtained from a liver lesion from a tebantafusp and ipi/pembro-failed uveal melanoma patient. The biomarker data presented indicates broad immune activation by RP2 and demonstrates that clinical response does not correlate with baseline PD-L1 and CD8 expression status. Clinical responses were often associated with increases in gene signatures associated with cytotoxic T, NK and Th1 cells. These data indicate the potential for broad utility of RP2 in a range of tumor types, including in patients with primary or acquired resistance to immune checkpoint blockade.

In tumour cells, expression of HLA-G and loss of CDX2 expression were associated with cancer recurrence. In addition, a combination of certain tumour tissue biomarkers was associated with colorectal cancer recurrence.

P2, N=161, Recruiting, Novartis Pharmaceuticals | Trial completion date: Jan 2023 --> May 2023 | Trial primary completion date: Jan 2023 --> May 2023