Pfizer has announced the results from a phase 3 bladder cancer trial, showing that its PD-1 inhibitor sasanlimab reduced the risk of disease-related events by 32%. However, the study did not demonstrate overall survival benefits and saw an increased rate of serious adverse events in the treatment arm.
The trial found patients who received sasanlimab plus Bacillus Calmette-Guérin (BCG) had a higher probability of being free from event-free survival endpoints at 36 months. However, removing BCG maintenance doses negatively affected outcomes, indicating that BCG will remain part of the regimen even if sasanlimab becomes an established therapy.
The trial also found that patients who received sasanlimab plus BCG induction had a higher rate of serious treatment-related adverse events compared to the control group. The most common grade 3 or 4 immune-mediated adverse events were hepatitis and pancreatitis, which resolved with thyroid hormone supplementation.
Pfizer has shared the results with regulatory authorities to support potential filings for sasanlimab’s approval in bladder cancer. If approved, sasanlimab could become the first PD-1 drug approved in this indication, furthering Pfizer’s plans to use it in combination with its antibody-drug conjugates.
Source: https://www.fiercebiotech.com/biotech/pfizer-ties-pd-1-drug-32-bladder-cancer-risk-reduction-phase-3-misses-secondaries