WASHINGTON -- Adding immunotherapy to standard treatment for non-muscle invasive bladder cancer (NMIBC) achieved complete response (CR) in more than 90% of patients who had refused cystectomy for high-risk disease, a small prospective study showed.
Only three of 37 patients did not have a CR at 6 months with pembrolizumab (Keytruda) and Bacille Calmette-Guérin (BCG). After a median follow-up of 22 months, no patient had progressed to MIBC or developed metastasis. Four patients had high-grade recurrence. At 12 months, 94% of the patients were disease free with an intact bladder.
Most patients had treatment-related adverse events (TRAEs), including severe (≥3) immune-related AEs in a fifth of patients, but the safety profile was consistent with previous studies of an immunotherapy-BCG combination, reported Eugene Pietzak, MD, of Memorial Sloan-Kettering Cancer Center in New York City, at the American Urological Association (AUA) annual meeting.
"We believe our findings support pembrolizumab plus BCG as a potential bladder-preserving option in carefully selected patients who decline cystectomy but are at very high risk for progression with BCG alone," said Pietzak.
The pembrolizumab-BCG combination joins a growing number of regimens vying for a role in treating high-risk NMIBC. Within the past year, three phase III randomized trials have been reported, each involving a different PD-L1 inhibitor.
