Pfizer Withdraws EU Bladder Cancer Filing After CHMP Concerns
核心洞察
Pfizer withdrew its EU marketing authorization application for subcutaneous anti-PD-1 (搜索) antibody Zumrad (搜索) (sasanlimab) in BCG-naive, high-risk non-muscle invasive bladder cancer (搜索) on 13 February 2026.
The EMA's CHMP provisionally concluded the drug could not be authorized, citing protocol changes during the pivotal CREST trial and a statistical analysis method altered to favor a positive result.
Regulators also flagged the unblinded investigator-assessed event-free survival endpoint as potentially biased and noted overall survival data did not support the primary finding.
Pfizer's European marketing authorization application for Zumrad (搜索) (sasanlimab), a subcutaneous anti-PD-1 (搜索) monoclonal antibody intended for use with Bacillus Calmette-Guerin (BCG) in BCG-naive, high-risk non-muscle invasive bladder cancer (搜索) (NMIBC), was withdrawn on 13 February 2026, according to a notice from the European Medicines Agency (搜索). The EMA's Committee for Medicinal Products for Human Use had provisionally concluded that the drug could not be authorized based on the data submitted.
The CHMP identified several problems with the pivotal Phase III CREST trial: major protocol changes were made while the study was ongoing, the statistical analysis method was altered in ways that increased the probability of a positive result, and the primary endpoint of event-free survival assessed by unblinded investigators was considered potentially susceptible to bias. Overall survival, a key secondary endpoint, did not support the primary EFS finding. Pfizer said it withdrew the application to allow time to collect additional data and analyses.
CREST had reported a 32% reduction in the risk of disease-related events with sasanlimab plus BCG induction and maintenance versus BCG alone, with 82.1% of patients event-free at 36 months versus 74.8% in the control arm (hazard ratio 0.68; 95% CI 0.49-0.94; p=0.019). Overall survival showed no difference between arms at a median follow-up of 40.9 months, and serious treatment-related adverse events occurred in 17.7% of the sasanlimab plus BCG arm versus 1.4% of controls. The withdrawal follows AstraZeneca's June 2026 decision to pull an EU application for Imfinzi (durvalumab) plus BCG in the same setting after the CHMP found the disease-free survival benefit of uncertain clinical relevance and outweighed by added toxicity. Pfizer said there are no consequences for patients currently enrolled in sasanlimab trials and has not indicated a timeline for resubmission.