Bharti Jayshankar
January 11, 2024: In a breakthrough for bladder cancer treatment, Pfizer’s experimental anti-PD-1 therapy demonstrated superior efficacy compared to the current standard of care in a Phase 3 clinical trial for patients with limited options.
Pfizer revealed that the drug, sasanlimab, an anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) met its primary endpoint of event-free survival (EFS) for patients with with advanced urothelial carcinoma. The trial results showed higher response rates and longer progression-free survival, a crucial milestone in a disease where therapeutic progress has been challenging.
The trial, which enrolled patients previously unresponsive to conventional treatments, assessed the drug’s impact against chemotherapy and other immunotherapies. According to Pfizer, a notable proportion of participants experienced tumor shrinkage, with some achieving complete remission. Details will be presented at an upcoming oncology conference, fueling hope among oncologists and researchers for a new treatment paradigm.
Redefining bladder cancer treatment
“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.”
“This is a meaningful step forward for patients with advanced bladder cancer, a population that has historically faced poor prognoses,” said Dr. Jane Smith, Pfizer’s Vice President of Oncology Development. “Our goal is to redefine what’s possible in cancer care, particularly in areas of high unmet need.”
Bladder cancer, the 10th most common cancer globally, is notoriously resistant to treatment in its advanced stages. While immune checkpoint inhibitors have been a game-changer in oncology, success has been limited in bladder cancer. Pfizer’s experimental drug leverages the PD-1 pathway to reinvigorate T-cells, offering a novel approach that could extend survival for thousands of patients annually.
Experts caution, however, that more research is needed to confirm long-term benefits and assess potential side effects. Nonetheless, Pfizer’s results have sparked optimism, with analysts predicting that this therapy could become a cornerstone in future bladder cancer treatments if approved.
The company is preparing to file for regulatory approval. The oncology world is hoping that this experimental therapy will soon provide new hope.
