Zinger Key Points
- Pfizer's Phase 3 trial showed sasanlimab with BCG improved event-free survival in high-risk NMIBC patients.
- Sasanlimab's safety profile aligns with known PD-1 inhibitors and BCG data from previous trials.
On Friday, Pfizer Inc. PFE released topline results from its Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance for BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
The study met its primary endpoint of event-free survival by investigator assessment, showing a clinically meaningful and statistically significant improvement with sasanlimab in combination with BCG as compared to BCG alone.
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Each year, around 100,000 individuals worldwide receive a diagnosis of high-risk NMIBC.
The overall safety profile of sasanlimab in combination with BCG was generally consistent with the known profile of BCG and data reported from clinical trials with sasanlimab.
The profile of sasanlimab was also generally consistent with the reported safety profile of PD-1 inhibitors.
The company plans to submit results for presentation at an upcoming medical congress.
Pfizer intends to discuss these data with global health authorities to support potential regulatory filings. Sasanlimab also continues to be investigated in combination with Pfizer’s antibody-drug conjugate portfolio in advanced solid tumors.
Price Action: PFE stock is up 0.28% to $26.94 at last check Friday.
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