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Thomas Flaig, MD


ASCO 2022: Neoadjuvant Targeting of PD-1 Plus SBRT in Muscle-Invasive Bladder Cancer

By: Lauren Harrison, MD, MS
Posted: Tuesday, June 7, 2022

Sasanlimab, a humanized immunoglobulin G (IgG) monoclonal antibody that selectively targets PD-1, in combination with stereotactic body radiation therapy (SBRT) is being tested as a neoadjuvant therapy for patients with muscle-invasive bladder cancer who are ineligible to receive cisplatin. Raj Satkunasivam, MD, MS, of the Houston Methodist Hospital, presented the methods of this phase II study on behalf of colleagues at the 2022 American Society for Clinical Oncology (ASCO) Annual Meeting (Abstract TPS4611).

This prospective, single-arm trial began enrolling patients in February 2022. Patients selected for this trial must have muscle-invasive bladder cancer and either refuse cisplatin therapy or be ineligible due to a low performance status, kidney function, hearing loss, neuropathy, or other comorbidity. Those enrolled will be given 300 mg of subcutaneous sasanlimab on day 1 of each 28-day cycle for two total cycles. In addition, patients will undergo SBRT to the primary tumor at a dose of 24 Gy in three fractions starting on day 1 of the second cycle. After this neoadjuvant therapy, patients will undergo radical cystectomy. The first 10 patients will be enrolled as a safety lead-in to assess the safety and feasibility of this treatment.

After 18 patients have undergone treatment, futility analysis will be performed. The primary endpoint of the trial is pathologic complete response rate after neoadjuvant therapy and cystectomy. If a pathologic complete response is observed in fewer than five patients, enrollment will be stopped with the conclusion that pT0 cannot be higher than 40%. If a complete response is seen in 5 or more patients, then an additional 15 patients will be enrolled, resulting in a total of 33 patients.

In addition to response rates, researchers will assess adverse events, surgical complication rates, quality of life, overall survival, and recurrence-free survival in this cohort. Other endpoints will include analysis of complete response of the tumor/germline genetic signatures, circulating tumor DNA, tumor PD-L1 expression, and immune response.

Disclosure: For a full list of author disclosures, visit

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