HQ Team
January 10, 2025: Pizer Inc.’s late-stage trial of an antibody treatment for a certain type of bladder cancer has shown significant improvement in time patients remained free of complications, according to a company statement.
The investigational sasanlimab, a monoclonal antibody, was tested in patients with a combination of Bacillus Calmette-Guérin (BCG), meant to treat tuberculosis, and BCG alone. The medicine was tested on patients who had high-risk, non-muscle invasive bladder cancer.
The study met its primary endpoint of event-free survival by investigator assessment, “demonstrating a clinically meaningful and statistically significant improvement” with sasanlimab in combination with BCG as compared to BCG alone, according to the Pfizer statement.
High-risk, non-muscle invasive bladder cancer is an area of significant unmet need, where therapeutic options have largely remained unchanged for over three decades.
‘High rate of recurrence’
“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 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, 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,” he said.
About 100,000 people worldwide are diagnosed yearly with high-risk cancer. Induction therapy with BCG followed by maintenance has been the standard of care for patients with high-risk NMIBC for decades.
‘No advanced therapies’
Almost 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. 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, M.D., Chief Oncology Officer of Pfizer.
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 tumours.
