▎WuXiEdited by the Kant Content Team

Pfizer today announced that its PD-1-targeted monoclonal antibody, sasanlimab, met the primary endpoint in the pivotal Phase 3 CREST trial. Sasanlimab, in combination with Bacillus Calmette-Guérin (BCG) as induction therapy (with or without maintenance therapy), significantly improved event-free survival (EFS) in BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC) patients. According to the press release,If approved, sasanlimab will become the first PD-1 inhibitor to be used in combination with BCG, significantly extending EFS in this patient population.Pfizer Plans to Discuss These Data with Global Regulatory Agencies to Support Potential Regulatory Submissions.

Approximately every year1010,000 patients have been diagnosed with high-risk non-muscle-invasive bladder cancer. For such patients,BCGInduction therapy combined with subsequent maintenance therapy has become the standard treatment for decades. However, there are still40-50%Patients may experience recurrent disease, which often necessitates radical cystectomy—a procedure associated with significant risks. Meanwhile, bladder-sparing treatment options remain very limited.For treatment-naïve high-risk NMIBC patients, there is a significant unmet need in this area, and over the past thirty years, the available treatment options have hardly changed.

CREST is a randomized, open-label Phase 3 trial. The analysis shows that the trial met the primary endpoint of EFS assessed by the investigators. The results show,Compared with BCG alone (induction and maintenance therapy), sasanlimab combined with BCG has demonstrated significant clinical efficacy., and achieved statistically significant improvement.

SasanlimabUnitedBCGThe overall safety profile is consistent withBCGKnown safety features andsasanlimabThe data reported in clinical trials are basically consistent. Meanwhile,sasanlimabThe overall safety profile is also consistent with what has been reported.PD-1The safety profile of the inhibitor is consistent.

Sasanlimab is a humanized IgG4 monoclonal antibody.By binding to the PD-1 protein, it blocks its interaction with the ligands PD-L1 and PD-L2. PD-1 is an immune checkpoint protein expressed on T cells, dendritic cells, natural killer cells, macrophages, and B cells. Once activated by its ligand, it can negatively regulate T-cell activation and effector function, and may play a significant role in the process of tumor immune escape.