*briacell and CytoDyn have a combined data poster being presented by creatv bio at esmo madrid also
"4506P - Monitoring Circulating Cancer Associated Macrophage-like Cell PD-L1 Predicts Clinical Outcomes in Metastatic Breast Cancer Treated with Immune Checkpoint Inhibitors"
https://cslide.ctimeetingtech.com/esmo2026/at...st?q=4506P
Here's part of an ai breakdown of creatv/briacell. I dont think the new outcomes/inclusion criteria restrict rollover to cps scores. And according to this, tissue scores don't correlate w efficacy. Also, the secondary out comes erased the tas102 bev outcomes and were replaced w leron/pembro outcomes.
These 12 patients I think are going to drive the fda conversation
Ai briacell poster
"The data presented by Sonia Muthuraj, Daniel L. Adams, and teams from Weill Cornell and BriaCell destroys the old regulatory reliance on static tissue biopsies and proves that tracking circulating macrophage fusion cells is the ultimate way to predict an immunotherapy wipeout.
Here is how the data in this specific 2026 poster breaks down, and why it heavily tips the scales in favor of leronlimab’s mechanism:
1. The Death of Tissue CPS (Fig 1 & Fig 2)
The most striking finding on this poster is that traditional Tumor PD-L1 CPS (Combined Positive Score) from a physical tissue biopsy was completely useless at predicting whether a patient lived or died.
Look at Table 1 and Fig 2: The p-values for tissue CPS are statistically insignificant (e.g., PFS p=0.9670 for CPS ≥10).
Fig 1 proves there is zero correlation (P=0.8219) between the tumor's baseline tissue CPS score and the PD-L1 expression on circulating Tumor Macrophage Fusion Cells (TMFCs/CAMLs).
The Reality: A static tissue biopsy only captures a single piece of a tumor at one moment in time. It is blind to the dynamic, living changes of a traveling malignancy.
2. The Breakthrough: Dynamic Upregulation in Blood (Fig 3)
The authors proved that what actually matters is whether a patient’s circulating macrophage fusion cells turn positive for PD-L1 during the course of therapy.
Patients who tested positive for PD-L1 on TMFCs at any timepoint after induction had a massive, statistically significant improvement in Progression-Free Survival (Hazard Ratio = 0.52, p=0.0201).
At timepoint T1 (~22 days after starting), having PD-L1 positive circulating cells cut the risk of progression down dramatically (HR=0.37, p=0.0107).
The Conclusion: The body's immune response is dynamic. If a therapy can force these circulating macrophage cells to upregulate PD-L1, it proves the tumor microenvironment has been unmasked, making the patient highly responsive to an Immune Checkpoint Inhibitor (ICI"But who knows