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A new analysis of the phase 3 KEYNOTE-B15 trial shows that the drug combo enfortumab vedotin plus pembrolizumab cleared circulating tumor DNA (ctDNA) more effectively than standard chemotherapy in muscle-invasive bladder cancer (MIBC) patients. ctDNA clearance was strongly linked to better event-free survival, regardless of which treatment patients received. The FDA has already approved the combination as a perioperative treatment for MIBC.
A new exploratory analysis from the phase 3 KEYNOTE-B15 trial, presented at the 2026 ESMO Congress, reveals that the combination of enfortumab vedotin (Padcev) plus pembrolizumab (Keytruda) cleared circulating tumor DNA (ctDNA) more effectively before surgery than standard gemcitabine plus cisplatin chemotherapy in patients with cisplatin-eligible muscle-invasive bladder cancer (MIBC).
ctDNA — tiny fragments of cancer DNA found in the bloodstream — emerged as a powerful prognostic tool across both treatment arms. Patients who cleared ctDNA before surgery had significantly better event-free survival (EFS) than those who didn't, and those who remained ctDNA-positive after surgery fared poorly regardless of which treatment they received, highlighting an important unmet need.
By the Numbers:
Why it matters: These findings reinforce ctDNA as a key biomarker for guiding treatment decisions in bladder cancer and suggest that EV/pembrolizumab offers a meaningful advantage over chemotherapy — not just clinically, but at the molecular level too.
