Pivotal Phase III Trial Data Show Pfizer’s Sasanlimab with BCG Significantly Improves Event-Free Survival in Bladder Cancer
In the pivotal CREST clinical trial, sasanlimab in combination with Bacillus Calmette-Guérin met the primary endpoint of event-free survival.
Pfizer has shared new data from the Phase III CREST clinical trial of sasanlimab in combination with standard of care Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). Sasanlimab, an investigational anti-PD-1 monoclonal antibody, alongside BCG, met CREST’s primary endpoint of event-free survival (EFS), demonstrating a clinically meaningful and statistically significant improvement compared to BCG alone.1
Findings from CREST show a 32% reduction in risk of disease-related events, including high-grade disease recurrence or progression. Additionally, the probability of being event-free at 36 months was 82.1% versus 74.8% with BCG alone.
In a press release, Neal Shore, MD, FACS, medical director for START Carolina Research Center, and lead investigator for the CREST trial, said: “New bladder cancer treatment options that help reduce rates of disease recurrence or progression are long overdue. Up to 50% of patients with high-risk non-muscle invasive bladder cancer may experience failure of BCG intravesical immunotherapy, yet it has been the standard of care after tumor resection for decade. These Phase III results show that combining sasanlimab with BCG induction and maintenance therapy earlier in the course of the disease significantly prolonged event-free survival, highlighting the value and potential of sasanlimab in combination with BCG to redefine the treatment paradigm and reduce the burden for patients.”
An early interim analysis for the key secondary endpoint of overall survival showed no difference between treatment arms, with a median follow-up of 40.9 months. The overall safety profile of sasanlimab plus BCG was generally consistent with the known profile of BCG and previously reported clinical data of sasanlimab.
In the press release, Megan O’Meara, MD, interim chief development officer, Pfizer Oncology, added: “Today’s pivotal Phase III CREST results offer a much-needed therapeutic breakthrough and spotlight sasanlimab as the first immunotherapy combination with BCG to significantly improve outcomes for patients with BCG-naïve, high-risk NMIBC in over three decades. The CREST findings are especially impactful for these patients with early-stage cancer who may benefit the most from innovative treatment regimens, including a subcutaneous immune checkpoint inhibitor, that delay disease recurrence or progression. These results underscore our long-standing commitment to patients with bladder cancer across all stages of the disease. We look forward to working with global regulatory authorities to potentially bring sasanlimab as an important new treatment option to patients with high-risk NMIBC.”
The Phase III CREST study (NCT04165317) is multinational, randomized, open-label, three parallel-arm trial. Patients were randomized to receive sasanlimab 300 mg every four weeks combined with BCG induction therapy once weekly for six consecutive weeks, with or without BCG maintenance.
Pfizer initially announced CREST had met its primary endpoint earlier in January. According to the company, if sasanlimab is approved, it would be the first PD-1 inhibitor in combination with BCG to significantly prolong EFS in this patient population.2
In a press release from the time, Shore said: “These study results demonstrate the potential for sasanlimab in combination with BCG to redefine the treatment paradigm for patients living with BCG-naïve, high-risk non-muscle invasive bladder cancer, including patients with carcinoma in-situ, providing prolonged event-free survival which may delay or reduce the need for more aggressive treatment options.”
References
1. Pfizer’s Sasanlimab Combination Significantly Improves Event-Free Survival in BCG-Naïve, High-Risk Non-Muscle Invasive Bladder Cancer. News release. Pfizer. April 26, 2025. Accessed April 28, 2025. https://www.businesswire.com/news/home/20250426868344/en/Pfizers-Sasanlimab-Combination-Significantly-Improves-Event-Free-Survival-in-BCG-Nave-High-Risk-Non-Muscle-Invasive-Bladder-Cancer
2. Pfizer’s Sasanlimab in Combination with BCG Improves Event-Free Survival in Patients with BCG-Naïve, High-Risk Non-Muscle Invasive Bladder Cancer. News release. Pfizer. January 10, 2025. Accessed April 28, 2025. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-sasanlimab-combination-bcg-improves-event-free
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