Pfizer's (PFE.US) immunotherapy trial for bladder cancer has achieved its primary endpoint, offering new hope for patients.

Pfizer (PFE.US) today announced that its PD-1-targeting antibody sasanlimab met the primary endpoint in the pivotal Phase 3 CREST trial. Sasanlimab, when used in combination with BCG as induction therapy (with or without maintenance therapy), significantly improved event-free survival (EFS) in patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). If approved, sasanlimab would be the first PD-1 inhibitor to significantly extend EFS when used in combination with BCG in this patient population, according to the press release. Pfizer plans to discuss these data with global regulatory authorities to support potential regulatory filings.

Approximately 100,000 patients are diagnosed with high-risk non-muscle-invasive bladder cancer each year. For these patients, BCG induction therapy combined with subsequent maintenance therapy has been the standard of care for decades. However, 40-50% of patients still experience disease recurrence, which often leads to the need for a radical cystectomy, a procedure associated with significant risks. Treatment options that preserve the bladder remain very limited. There is a significant unmet need in this area for patients with BCG-naïve, high-risk NMIBC, and the treatment options available have changed little in the past three decades.

CREST is a randomized, open-label Phase 3 trial. Analysis showed that the trial met the primary endpoint of EFS, as assessed by the investigator. Results showed that sasanlimab in combination with BCG demonstrated clinically meaningful efficacy and achieved statistical significance compared to BCG alone (induction and maintenance therapy).