Neal Shore, MD, on sasanlimab plus BCG for BCG-naïve NMIBC

Data from the phase 3 CREST trial (NCT04165317) reported that sasanlimab, an investigational checkpoint inhibitor, in combination with BCG improved event-free survival (EFS) vs BCG alone in patients with BCG-naïve high-risk non–muscle invasive bladder cancer (NMIBC). These data were presented at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada.

Presenting author Neal D. Shore, MD, FACS, sat down with Urology Times® at the meeting to offer his insights on these preliminary results. Shore is the medical director of START Carolinas, formerly the Carolina Urologic Research Center, in Myrtle Beach, South Carolina.

Commenting on the background for the study, Shore explained, “The rationale for combining BCG with a checkpoint blocker was that earlier studies have clearly demonstrated, both pre-clinically and in early phase, really nice work, that BCG stimulates PD expression. So, there was a synergy tied into the MOA of combining these 2 drugs.”

In total, the study included 1055 patients who were randomly assigned 1:1:1 to receive sansalimab in combination with BCG for induction and maintenance (n = 352), sasanlimab plus BCG for induction only (n = 352), or BCG alone for induction and maintenance (n = 351).

Data showed that the risk of experiencing an EFS event was 32% lower in arm A vs arm C (HR = .68; 95% CI, 0.49-0.94; 1-sided P-value = .0095).¹ Recurrence of high-grade disease was observed in 26 (7.4%) patients in arm A vs 53 (15.1%) patients in arm C. Persistence of carcinoma in situ was seen in 1 (0.3%) patient in each arm.

EFS was not found to be different between arm B and arm C. According to Shore, this finding shows that maintenance is beneficial.

Overall, Shore concluded, “I’m hopeful that we can get to approval and give patients other options. There are 3 other phase 3 trials that are looking at checkpoint blockade combining with BCG in the BCG-naive high-risk NMIBC population; CREST is the first one to report. So, excited to see what happens with that.”

According to Shore, we can expect to see additional data from the trial presented at the upcoming ASCO meeting in Chicago, Illinois.

REFERENCE

1. Shore ND, Powles T, Bedke J, et al. Sasanlimab in combination with Bacillus Calmette-Guérin improves event-free survival versus Bacillus Calmette Guérin as standard of care in high-risk non-muscle invasive bladder cancer: Phase 3 CREST study results. J Urol. 2025;213(5S)