CREST: Sasanlimab Plus BCG Improves Event-Free Survival for Patients With HR NMIBC

New results from the phase 3 CREST trial have shown that the combination of sasanlimab and bacillus Calmette-Guérin (BCG) provides a significant improvement for patients with BCG-naive, high-risk (HR) non-muscle invasive bladder cancer (NMIBC) over BCG alone. 

The study met its primary endpoint of event-free survival (EFS) for the combination induction therapy, which had a safety profile consistent with data reported from previous clinical trials of the two treatments. 

During the CREST trial, patients were randomly assigned to one of three treatment arms. Arm A consisted of subcutaneous sasanlimab, 300 mg once every four weeks, for up to 25 cycles in combination with BCG once per week for six consecutive weeks, followed by maintenance with BCG. Arm B consisted of the same regimen of sasanlimab plus BCG as induction only, and arm C involved BCG induction and maintenance alone up to cycle 25. 

Investigator-assessed EFS was the primary endpoint of arms A and C, defined as the time from randomization to the earliest recurrence of high-grade disease, progression of disease, persistence of carcinoma in situ, or death. The secondary endpoint was EFS as assessed by investigator between arm B and arm C. 

“The initial therapy of high-risk, non-muscle invasive bladder cancer with BCG has not advanced in decades. Today’s pivotal Phase 3 CREST results are potentially practice-changing, representing the first advance in therapy for BCG-naïve, high-risk, non-muscle invasive cancer in over 30 years,” said Roger Dansey, MD, Chief Oncology Officer, Pfizer.  

Further results of the trial will be presented at an upcoming medical conference. Sasanlimab is being further studied in combination with other antibody drug conjugate treatments for advanced solid tumors.