PIVOT IO 009 Trial

Arlene O. Siefker-Radtke, MD:A current unmet need in our patients requiring neoadjuvant chemotherapy is that a large number of patients are not candidates for cisplatin-based chemotherapy. Carboplatin-based treatment has been largely ineffective in achieving a substantial cure fraction for patients undergoing neoadjuvant treatment.

PIVOT IO 009 is a clinical trial combining bempegaldesleukin with nivolumab in patients with muscle-invasive bladder cancer who require neoadjuvant chemotherapy but are ineligible for cisplatin-based chemotherapy. This clinical trial has 3 arms for which patients will be randomized. Arm 1 is the combination of bempegaldesleukin with nivolumab. Patients will receive treatment followed by cystectomy, and then 9 months of the combination in the adjuvant setting.

The second arm of this clinical trial utilizes single-agent nivolumab for the treatment of these patients. Following cystectomy, patients will receive an additional 9 months of nivolumab in the adjuvant setting.

The third arm is a standard-of-care arm. Since these are patients who are not eligible for cisplatin-based chemotherapy, the standard of care has been to proceed with cystectomy. By randomizing between these 3 arms we hope to gain an understanding on how the combination of bempegaldesleukin with nivolumab compares with single-agent nivolumab, and also that these are better than the current standard of care, which is initial surgery.

The endpoints of the trial include coprimary endpoints looking at pathologic complete response rate and event-free survival based upon occurrence of metastatic disease. This is an approximately 500-patient trial that is currently being evaluated by multiple sites, and I’m hopeful that multiple centers, including your own, will be interested in participating in this trial.

With a complete response rate in metastatic disease that is 19%, this appears similar to the complete response rate observed with the dose-dense treatment. And when you consider the historical significance of achieving a clinical complete response and impacting curative patients, I remain hopeful that this is a strategy that will be beneficial for the treatment of our neoadjuvant patients who are not candidates for the current standard of care, curative cisplatin-based chemotherapy.

Transcript edited for clarity.