Bladder Cancer Patients Maintain Quality of Life With Sasanlimab Combo

Patient reported outcomes from the phase 3 CREST study showed that quality of life was maintained when combining sasanlimab with Bacillus Calmette-Guérin (BCG) versus BCG alone, both as induction and maintenance therapy, according to study findings presented at the 2025 ASCO Annual Meeting.

As of the data cutoff on December 2, 2024, 695 of the 703 patients randomized to Arms A (348 patients) and C (347 patients) had both a baseline and at least one follow-up quality-of-life score. More than 84% of patients completed quality-of-life assessments at every visit through the end-of-treatment point (Cycle 25).

Quality of life was assessed using two patient-reported outcome questionnaires: the EORTC QLQ-C30 and the NMIBC24. The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) is a widely used tool that measures various aspects of health-related quality of life in people with cancer. It includes questions on physical function, fatigue, pain, emotional well-being and overall health status. One key metric is the “Global Health Status” score, which ranges from 0 to 100; higher scores indicate better perceived overall health and quality of life.

In this study, Global Health scores were numerically similar between the two treatment arms. The average difference between the arms did not meet the 10-point threshold commonly used to define a clinically meaningful change.

The NMIBC24 questionnaire is a disease-specific module developed for patients with non–muscle-invasive bladder cancer. It captures symptoms and side effects that may be especially relevant for this group, such as urinary symptoms, sexual function, and concerns related to intravesical (bladder-administered) treatments.

Results from the NMIBC24 also showed no clinically meaningful differences between the treatment arms in urinary symptoms or issues related to intravesical therapy. Across other quality-of-life domains included in the QLQ-C30, no notable differences emerged.

One exception was a statistically significant increase in reported sexual problems among a small subgroup of female patients in one treatment arm. However, this increase did not meet the 10-point threshold for clinical significance, meaning it’s unclear whether the difference would be noticeable or meaningful in patients’ day-to-day lives.

Sasanlimab combined with BCG, given as both induction and maintenance therapy, led to a significant improvement in event-free survival compared with BCG alone in patients with high-risk, BCG-naive non–muscle-invasive bladder cancer, according to primary findings from the phase 3 CREST study. The treatment was also associated with a manageable safety profile. The newly reported patient-reported outcome data from CREST further explored how this treatment combination affected quality of life, focusing on patients in Arms A and C.

Trial Design

Patients in the trial were randomly assigned to one of three treatment groups: sasanlimab with BCG given as both induction and maintenance therapy (Arm A), sasanlimab with BCG given as induction only (Arm B), or BCG alone given as both induction and maintenance therapy (Arm C). Quality-of-life results were secondary endpoints and not part of the study’s formal testing plan.

Patients completed quality-of-life questionnaires at the start of treatment and at regular follow-up visits every four weeks through week 28, then every 12 weeks through week 100 and during disease follow-up.

Primary end points were event-free survival in Cohorts A and B2, and complete response rate in Cohort B1. Event-free survival measured time to progression or death. Cohorts B1 and B2 were discontinued before completing enrollment.

Reference

1. “Sasanlimab in combination with bacillus Calmette-Guérin (BCG) in BCG-naive in BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): Patient-reported outcomes (PROs) from CREST,” by Dr. Andrea Apolo, et al., ASCO Annual Meeting.

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