| Clinical data | |
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| Other names | PF-06801591 |
| Routes of administration | Subcutaneous injection |
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| Chemical and physical data | |
| Formula | C6508H10000N1716O2044S46 |
| Molar mass | 146460.32 g·mol−1 |
Sasanlimab (developmental code PF-06801591) is an investigational humanized monoclonal antibody that targets the programmed cell death protein 1 (PD-1) receptor. [1] Developed by Pfizer, it is being investigated as an immune checkpoint inhibitor for the treatment of various cancers, with particular focus on bladder cancer. [2]
Sasanlimab is a humanized immunoglobulin G4 (IgG4-κ) monoclonal antibody that selectively binds to the PD-1 receptor on T cells and other immune cells. [3] By blocking the interaction between PD-1 and its ligands (PD-L1 and PD-L2), sasanlimab prevents the inhibitory signaling that normally suppresses T cell activation. [4] This mechanism allows the immune system to maintain its anti-tumor response, potentially leading to tumor regression.
The antibody is produced in Chinese hamster ovary (CHO) cells and is administered via subcutaneous injection, which distinguishes it from many other PD-1 inhibitors that require intravenous administration. [3]
Sasanlimab was first evaluated in a phase I dose-escalation study (NCT02573259) in patients with advanced or metastatic solid tumors. [5] The study demonstrated durable anti-tumor activity and a manageable safety profile across various solid tumor types. [2] [6]
In dose expansion cohorts, sasanlimab showed promising clinical efficacy in patients with non-small-cell lung cancer (NSCLC) and urothelial carcinoma. For NSCLC patients, the confirmed objective response rate (ORR) was 16.4%, with a median overall survival of 14.7 months and median progression-free survival of 3.7 months. [5]
The pivotal Phase III CREST trial represents the most significant clinical development for sasanlimab. [7] This randomized, open-label study evaluated sasanlimab in combination with Bacillus Calmette-Guérin (BCG) as induction therapy in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). [8]
The trial demonstrated a statistically significant improvement in event-free survival, with sasanlimab plus BCG showing superior efficacy compared to BCG alone. [2] However, the combination did not show a significant effect on overall survival and was associated with a higher rate of serious adverse events compared to BCG monotherapy. [9]
Several other clinical trials are investigating sasanlimab in different settings including :
Based on clinical trial data, sasanlimab demonstrates a safety profile consistent with other PD-1 inhibitors. The subcutaneous route of administration may offer advantages in terms of patient convenience and healthcare resource utilization compared to intravenous alternatives. [5] In the CREST trial, the combination of sasanlimab with BCG was associated with an increased rate of serious adverse events compared to BCG alone, which is an important consideration for the risk-benefit assessment in clinical practice. [9]
As of September 2025, sasanlimab remains an investigational drug without regulatory approval from major health authorities. The positive results from the Phase III CREST trial may support future regulatory submissions for the treatment of high-risk NMIBC in combination with BCG. [15]
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