Pfizer Inc. (PFE), on Friday, announced that its pivotal Phase 3 trial of investigational anti-PD-1 monoclonal antibody, Sasanlimab, in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer has yielded positive results.
In the phase III trial, dubbed CREST, Sasanlimab was evaluated 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).
According to the study findings, the primary endpoint of event-free survival was met, demonstrating a clinically meaningful and statistically significant improvement with Sasanlimab in combination with BCG (induction and maintenance) compared to BCG alone.
This marks the first major advance in treatment for this patient population in over three decades, noted the company.
Sasanlimab, if approved, would be the first PD-1 inhibitor to significantly prolong event-free survival when combined with BCG.
Patients with high-risk NMIBC, particularly those with carcinoma in situ (CIS), often face high recurrence rates and limited treatment options after BCG therapy.
The safety profile of sasanlimab in combination with BCG was consistent with that of BCG alone and similar to what has been observed in clinical trials of other PD-1 inhibitors.
Pfizer plans to submit the results for presentation at an upcoming medical congress and will discuss the data with global health authorities to support potential regulatory filings.
Roger Dansey, M.D., Chief Oncology Officer at Pfizer, highlighted the transformative nature of these results, stating that they represent the first significant advancement in therapy for BCG-naïve, high-risk NMIBC in over 30 years.
If approved, Sasanlimab in combination with BCG could offer a much-needed new treatment option for this patient population, potentially delaying or reducing the need for more aggressive treatments like radical cystectomy.
PFE closed Thursday's (Jan.09,2025) trading at $26.86, down 1.00%. In premarket trading, the stock is up 0.52% at $27.00.
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