A new treatment combination has shown significant promise for patients with high-risk, non–muscle-invasive bladder cancer (NMIBC) who have not previously received BCG (Bacillus Calmette-Guérin) therapy. In the phase 3 CREST clinical trial, adding the immunotherapy drug sasanlimab to standard BCG induction and maintenance therapy led to a meaningful improvement in how long patients remained free from cancer recurrence or progression, compared to BCG therapy alone.
- Patients receiving sasanlimab plus BCG had a 32% lower risk of experiencing a cancer event (such as recurrence or progression) compared to those on BCG alone.
- At three years, 82.1% of patients on the combination treatment were event-free, versus 74.8% of those on BCG alone.
- The benefit was consistent across different patient groups, including those with more aggressive disease types.
What Is Sasanlimab?
Sasanlimab is an investigational immunotherapy that targets the PD-1 pathway, helping the immune system recognize and attack cancer cells. It is given as a subcutaneous (under the skin) injection every four weeks.
Why Does This Matter?
For decades, BCG has been the mainstay treatment for high-risk NMIBC after tumor removal, but up to half of patients experience recurrence or progression, sometimes requiring major surgery. The results from CREST represent the first major advance in more than 30 years for this group of patients, offering a new potential option to delay or avoid more aggressive treatments.
Safety Profile
The safety of sasanlimab combined with BCG was in line with what is already known for these types of therapies. The most common side effects included urinary symptoms and mild laboratory abnormalities. Serious treatment-related side effects were seen in about 18% of patients, but no new safety concerns were identified6.
What’s Next?
The results from the CREST trial have been presented to global health authorities and could support future regulatory approvals, potentially making this combination available to more patients in need.
This combination could represent a new standard of care for patients with high-risk NMIBC who have not previously received BCG therapy.
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References
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. Presented at: 2025 AUA Annual Meeting; April 26-29, 2025; Las Vegas, NV.
