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Sasanlimab

Clinical trials are investigating Sasanlimab in bladder cancer. These studies look at how well it works, how safe it is in trial settings, and which patients may benefit most, including people with non-muscle invasive bladder cancer and muscle invasive bladder cancer.

Table of contents

Overview of the trial program

The trial data show three interventional studies of Sasanlimab in bladder cancer.[1][2][3] Two studies are Phase 2 and one is Phase 3, so the program includes both smaller and larger research studies.[1][2][3] All three studies are listed as authorised.[1][2][3]

These trials focus on different bladder cancer groups, including non-muscle invasive bladder cancer and muscle invasive bladder cancer.[1][2][3] Some studies focus on people whose disease did not respond to BCG, which is a bladder treatment used in some patients.[1][2]

Trials in non-muscle invasive bladder cancer

One Phase 2 study is a prospective, open-label, multi-centre, single-arm trial of Sasanlimab plus sacituzumab govitecan in people with BCG-unresponsive non-muscle invasive bladder cancer.[1] Open-label means both the study team and the participant know which treatment is given, and single-arm means there is no separate comparison group in that study.[1]

This Phase 2 study plans to enroll 42 participants.[1] Its main goal is to measure the complete response (CR) rate of high-grade disease at 3 months, using cystoscopy, urine cytology, and biopsy when needed.[1] In simple terms, the study is checking how many patients have no sign of the targeted high-grade cancer after treatment.

The Phase 3 CREST study is larger and includes 1,070 participants with high-risk non-muscle invasive bladder cancer.[2] It studies Sasanlimab, also listed as PF-06801591, in combination with BCG or as a single agent in participants who do not respond to BCG.[2] The study has different cohorts, which are separate groups inside the same trial.[2]

In the CREST study, Cohort A looks at BCG-naïve participants, meaning people who have not had BCG before.[2] The trial aims to show that PF-06801591 plus BCG is better than BCG alone in prolonging event-free survival (EFS).[2] For BCG-unresponsive cohorts, the study measures CR in Cohort B1 and EFS in Cohort B2.[2]

Trial in muscle invasive bladder cancer

Another Phase 2 study looks at Sasanlimab as a bladder-sparing strategy for people with molecularly categorized muscle invasive bladder cancer.[3] Bladder-sparing means the study is trying to keep the bladder in place instead of moving quickly to bladder removal surgery.[3] This study plans to enroll 70 participants.[3]

The main endpoint is bladder-intact overall survival at 12 months after the first dose of Sasanlimab.[3] This means the study checks how many patients are alive and have not had cystectomy, which is surgery to remove the bladder, at 12 months.[3] The trial uses this measure to see whether Sasanlimab may help patients avoid bladder removal for at least one year after treatment starts.[3]

Main trial endpoints and what they mean

The trials use endpoints, which are the main results the researchers want to measure.[1][2][3] One endpoint is complete response, meaning the cancer cannot be seen or detected in the tested area at the planned time point.[1][2]

Another endpoint is event-free survival, which tracks how long participants stay free from a cancer-related event such as worsening disease or another major treatment step.[2] The muscle invasive bladder cancer study uses bladder-intact overall survival, which combines survival and avoiding cystectomy.[3] These outcomes help researchers understand whether the treatment may control the cancer and affect future treatment needs.[1][2][3]

Who the trials are for

The trial groups are defined by bladder cancer type and prior treatment response.[1][2][3] Some participants have high-risk non-muscle invasive bladder cancer, some have BCG-unresponsive disease, and others have molecularly categorized muscle invasive bladder cancer.[1][2][3]

In the CREST trial, the studies are split into cohorts, so different patient groups are studied with different goals.[2] This design helps researchers compare treatment effects in people who have not used BCG before and in those whose disease has not responded to BCG.[2]

How the studies are designed

All three studies are interventional, which means they give a study treatment and then measure the results.[1][2][3] The Phase 2 trial in non-muscle invasive bladder cancer is open-label and single-arm, while the Phase 3 CREST study is a larger program with multiple cohorts.[1][2]

The trial titles also show that Sasanlimab is studied both alone and in combination with other treatments.[1][2][3] In the Phase 2 bladder cancer study, it is combined with sacituzumab govitecan.[1] In the Phase 3 CREST study, it is studied with BCG or as a single agent.[2] In the muscle invasive bladder cancer study, the trial text lists Sasanlimab and PF-06801591 as the intervention names.[3]

Trial ID Phase Condition studied Status Enrollment
2023-509089-39-00 Phase 3 High-risk non-muscle invasive bladder cancer; BCG-unresponsive non-muscle invasive bladder cancer Authorised 1070
2024-518486-10-00 Phase 2 BCG-unresponsive non-muscle invasive bladder cancer Authorised 42
2024-511358-36-00 Phase 2 Molecularly categorized muscle invasive bladder cancer Authorised 70

FAQ

  • What conditions are being studied in Sasanlimab trials? The trials in this set study bladder cancer, mainly non-muscle invasive bladder cancer and muscle invasive bladder cancer. Some studies focus on high-risk disease or disease that did not respond to BCG.
  • Who may join these Sasanlimab trials? The target groups include people with high-risk non-muscle invasive bladder cancer, BCG-unresponsive non-muscle invasive bladder cancer, and molecularly categorized muscle invasive bladder cancer. Each trial has its own entry rules.
  • What phases are the Sasanlimab trials? The trials here are Phase 2 and Phase 3 studies. Phase 2 usually looks at early signs of benefit, while Phase 3 compares treatments in larger groups.
  • What are the trials trying to measure? The studies measure outcomes such as complete response, event-free survival, and bladder-intact overall survival. These outcomes show whether the cancer improves, stays controlled, or whether the bladder can be kept in place.
  • Are these Sasanlimab studies treatment trials? Yes. All three studies are interventional trials, which means participants receive a study treatment rather than only being observed.

Ongoing Clinical Trials on Sasanlimab

  • Study of Sasanlimab Treatment as a Bladder-Sparing Strategy in Patients with Muscle Invasive Bladder Cancer

    Not recruiting

    1 1
    Investigated drugs:
    Spain

  • Study of Sasanlimab with BCG or Alone for Patients with High-Risk Non-Muscle Invasive Bladder Cancer Not Responding to BCG

    Not recruiting

    1 1 1
    Investigated drugs:
    Belgium France Germany Italy Poland Spain

  • Study of Sasanlimab and Sacituzumab Govitecan for Patients with BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Bladder cancer: Cancer that starts in the bladder, the organ that stores urine.
  • Non-muscle invasive bladder cancer (NMIBC): Bladder cancer that has not grown into the muscle layer of the bladder.
  • Muscle invasive bladder cancer: Bladder cancer that has grown into the muscle layer of the bladder.
  • High-risk disease: A form of cancer that has a higher chance of coming back or getting worse.
  • BCG: A bladder treatment used in some bladder cancer patients. In the trial data, some patients do not respond to it.
  • BCG-unresponsive: Cancer that does not improve after BCG treatment.
  • Complete response (CR): A trial result meaning there is no visible sign of the target disease at the time of assessment.
  • Event-free survival (EFS): The length of time a person lives without a cancer-related event, such as worsening disease or another major treatment step.
  • Bladder-intact overall survival: The time a person stays alive without needing bladder removal surgery called cystectomy.
  • Cystoscopy: A procedure where a doctor looks inside the bladder using a thin camera.
  • Urine cytology: A lab test that checks urine cells for signs of cancer.
  • Biopsy: A small tissue sample taken for testing under a microscope.

References

  1. https://clinicaltrials.gov/study/2024-518486-10-00
  2. https://clinicaltrials.gov/study/2023-509089-39-00
  3. https://clinicaltrials.gov/study/2024-511358-36-00