Pfizer Sasanlimab, BCG combo improves event-free survival in patients with BCG-Naive, High-Risk Non-Muscle Invasive Bladder Cancer
New York: Pfizer Inc. has announced positive topline results from its pivotal Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). The study met its primary endpoint of event-free survival (EFS) by investigator assessment, demonstrating a clinically meaningful and statistically significant improvement with sasanlimab in combination with BCG (induction and maintenance) as compared to BCG alone (induction and maintenance).
“Patients with BCG-naïve high-risk non-muscle invasive bladder cancer have high rates of recurrence and progression,” said Neal Shore, M.D., FACS, Medical Director for the Carolina Urologic Research Center, and lead investigator for the CREST trial. “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 (CIS), providing prolonged event-free survival which may delay or reduce the need for more aggressive treatment options. Administered subcutaneously every four weeks, sasanlimab, if approved, could also help lower the treatment burden on both patients and healthcare systems.”
Each year, approximately 100,000 people globally are diagnosed with high-risk NMIBC. Induction therapy with BCG followed by maintenance has been the standard of care for patients with high-risk NMIBC for decades. 40-50% of patients experience recurrent disease, often requiring radical cystectomy, which is associated with significant risks and bladder-sparing treatment options are still limited.
“The initial therapy of high-risk, non-muscle invasive bladder cancer with BCG has not advanced in decades. The 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, M.D., Chief Oncology Officer, Pfizer. “These results reinforce Pfizer’s leadership in genitourinary cancer research and development, demonstrating our ongoing commitment to deliver new treatment options for patients with bladder cancer.”
The overall safety profile of sasanlimab in combination with BCG was generally consistent with the known profile of BCG and data reported from clinical trials with sasanlimab. The profile of sasanlimab was also generally consistent with the reported safety profile of PD-1 inhibitors.
Results will be submitted for presentation at an upcoming medical congress. Pfizer plans to discuss these data with global health authorities to support potential regulatory filings. Sasanlimab also continues to be investigated in combination with Pfizer’s antibody drug conjugate (ADC) portfolio in advanced solid tumors.
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