Pfizer’s Sasanlimab with BCG Improved Event-Free Survival in High-Risk Bladder Cancer

Pfizer Inc. has announced promising topline results from its pivotal Phase 3 CREST trial, which evaluated sasanlimab, an investigational anti-PD-1 monoclonal antibody, in combination with Bacillus Calmette-Guérin (BCG) for the treatment of BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).

The study successfully met its primary endpoint of event-free survival (EFS), showing a clinically meaningful and statistically significant improvement with sasanlimab combined with BCG (induction and maintenance) compared to BCG alone.

“The results from the CREST trial highlight the potential for sasanlimab in combination with BCG to reshape the treatment landscape for patients with BCG-naïve, high-risk NMIBC, This therapy could provide prolonged event-free survival, helping to delay or reduce the need for more aggressive treatments like radical cystectomy.” – Neal Shore, Medical Director for the Carolina Urologic Research Center and lead investigator for the CREST trial

High-risk NMIBC, which affects approximately 100,000 patients globally each year, has seen little advancement in treatment options over the past three decades.

Current standard care involves induction therapy with BCG followed by maintenance, but up to 40-50% of patients experience recurrence, often requiring more invasive procedures.

Pfizer’s sasanlimab, if approved, could offer an innovative approach with its subcutaneous administration every four weeks, potentially lowering treatment burden on both patients and healthcare systems.

Roger Dansey, Chief Oncology Officer at Pfizer, highlighted the groundbreaking nature of the results, stating, “The CREST trial results represent a critical advancement in the treatment of high-risk, BCG-naïve NMIBC. After decades of limited innovation, this therapy could be a game-changer for patients, marking the first significant progress in over 30 years.”

The safety profile of sasanlimab in combination with BCG was consistent with known safety data for BCG and PD-1 inhibitors.

Pfizer intends to present these results at an upcoming medical congress and discuss the findings with global health authorities as part of the regulatory review process.

In addition to its use in NMIBC, sasanlimab is also being investigated in combination with Pfizer’s antibody-drug conjugate (ADC) portfolio in advanced solid tumors.

About CREST

The CREST trial is a Phase 3, multinational, randomized, open-label study designed to evaluate sasanlimab, an anti-PD-1 monoclonal antibody, in combination with Bacillus Calmette-Guérin (BCG) for patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).

The trial includes three parallel arms: Arm A, which receives sasanlimab (300 mg) via subcutaneous injection every four weeks up to cycle 25 in combination with BCG induction for six weeks followed by BCG maintenance; Arm B, which receives sasanlimab and BCG induction with no maintenance; and Arm C, which receives BCG induction and maintenance up to cycle 25.

The primary endpoint is event-free survival (EFS), assessed by the investigator, comparing Arm A to Arm C, defined as the time from randomization to the earliest occurrence of recurrence of high-grade disease, disease progression, persistence of carcinoma in situ (CIS), or death.

Key secondary endpoints include EFS comparisons between Arm B and Arm C, as assessed by the investigator.