Another great effort by Cu6.The Phase 3 primary end point for...

Another great effort by Cu6.

The Phase 3 primary end point for 18F-DCFPyL (now SOC)
"The Correct Localization Rate (CLR) will be defined as percentage of participants with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT imaging and the composite truth standard. Within 60 days following PyL PET/CT imaging, either biopsy/surgery, conventional imaging, or locoregional radiation therapy of the PyL-suspected lesion(s) will be performed."

Result was an ~86% CLR from 208 patients and 3 readers. But the term at least one, leaves room for false positives, and importantly false negatives. It's unclear how many lesions 'SOC' fails to detect.

Comparing to 18F-DCFPyL seems fraught, particularly using Day 1 results for which there are none to compare to.

Putting my clinical trial design hat on....lol....maybe they could do Day 0 and Day 1 scans for both SOC and Cu64. Take the subset of Day 0 lesions seen in both SOC and Cu64 and compare them on Day 1. Presumably some of the SOC will not show up again on Day 1 but will for Cu64. Maybe by quantifying the change in SUVmax between lesion seen on both Day 0 and 1 for SOC (decrease?) and on both Day 0 and 1 for CU64 (increase or on average same?) they can show or infer that many of the exclusive Day 1 Cu64 lesions ('false positives') are simply not bright enough to show up in Day 1 SOC given the changes observed in SUVmax.

My gut feel is Cu64 is superior- personally I could live with false positives much more so than false negatives.