Pfizer’s sasanlimab, when used with standard of care, reduced the likelihood of disease recurrence or progression, death due to any cause or persistence of cancer cells by 32% in patients with high-risk non-muscle invasive bladder cancer.
Pfizer’s investigational anti-PD-1 antibody significantly reduced disease events in patients with high-risk non-muscle-invasive bladder cancer, according to results from a Phase III trial.
In a note to investors, Guggenheim analysts noted that these late-stage findings could help Pfizer carve out a “potential opportunity for sasanlimab in high-risk [non-muscle-invasive bladder cancer, NMIBC].” Its efficacy profile was “particularly compelling” in patients with carcinoma in situ (CIS), whose cancer hasn’t spread beyond its tissue of origin.
Guggenheim did flag a slight uptick in “immune-mediated adverse events” in patients who were treated with sasanlimab, but noted that doctors “appeared comfortable with the added toxicity given the added efficacy in this high-risk patient group.”
Pfizer presented the latest readout from the Phase III CREST trial on Saturday at the 2025 annual meeting of the American Urological Association. The trial combined sasanlimab with the standard of care, Bacillus Calmette-Guérin (BCG), and compared it against BCG alone. The study’s primary outcome was event-free survival (EFS).
Results showed that adding sasanlimab to BCG cut the risk of disease-related events by 32% in the overall study population. This effect was stronger in patients with early-stage or CIS disease, who saw risk reductions of 37% and 47%, respectively.
Additionally, Pfizer’s data demonstrated that patients in the sasanlimab arm had an 82.1% probability of being event-free at 36 months, as opposed to counterparts on BCG alone.
On the flip side, an early interim analysis for overall survival (OS) revealed that the sasanlimab regimen did not significantly outperform the BCG control at a median follow-up of 40.9 months. CREST will continue to follow patients for OS until its final analysis.
Pfizer noted in its presentation that the adverse event profile of sasanlimab was “generally consistent” with what had been established in prior studies, and with the known safety profile of PD-1 inhibitors. Common immune-mediated adverse events included rashes, hepatitis and pancreatitis.
The pharma said on Monday that it would share CREST’s data with global health authorities, with an eye toward securing approval for sasanlimab, though it hasn’t provided a timeline for a submission yet.
