Dados do Trabalho

Título

PHASE 2 STUDY OF PEMBROLIZUMAB WITH FAVEZELIMAB OR VIBOSTOLIMAB FOR PATIENTS WITH BACILLUS CALMETTE-GUERIN–UNRESPONSIVE HIGH-RISK NON–MUSCLE-INVASIVE BLADDER CANCER: COHORT C OF KEYNOTE-057

Introdução e Objetivo

Pembrolizumab monotherapy is effective for patients with bacillus Calmette-Guérin (BCG)–unresponsive high-risk non–muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) ± papillary tumors who are ineligible for or have elected not to undergo radical cystectomy, based on cohort A of the phase 2 KEYNOTE-057 study (NCT02625961). However, novel combinations that improve efficacy of pembrolizumab monotherapy are needed to further improve outcomes and durability of response. Cohort C will evaluate efficacy and safety of coformulations of pembrolizumab and the LAG-3 inhibitor favezelimab or the TIGIT inhibitor vibostolimab in patients with BCG-unresponsive high-risk NMIBC with CIS ± papillary tumors.

Método

Patients will be randomly assigned 1:1 to arm 1 (coformulation of pembrolizumab 200 mg and vibostolimab 200 mg) or arm 2 (coformulation of pembrolizumab 200 mg and favezelimab 800 mg) intravenously every 3 weeks for ≤35 administrations or until central pathology–confirmed ≥T1 at any time point or persistent or recurrent CIS or high-grade Ta at the 24-week efficacy review or thereafter. Adults with histologically confirmed BCG-unresponsive CIS (persistent or recurrent CIS alone or with Ta/T1 within 12 months of completion of adequate BCG therapy) who are ineligible for or elect not to undergo radical cystectomy and have an ECOG score of 0-2 will be eligible. Primary end point is 12-mo complete response rate of high-risk NMIBC determined by cystoscopy, cytology, biopsy, and radiologic imaging by central pathology and radiology review. Secondary end points include duration of response of high-risk NMIBC; overall complete response rate and rates at 3 and 6 months; progression-free survival to worsening of grade, stage, or death and to muscle-invasive or metastatic disease or death; and overall survival. Safety will be evaluated in patients receiving ≥1 dose of treatment.

Resultados

Enrollment is planned for 60 patients, and recruitment is ongoing in Asia, Australia, Europe, North America, and South America.

Conclusão

Results will provide further clarity on efficacy and safety of coformulations of pembrolizumab and favezelimab or vibostolimab in patients with BCG-unresponsive high-risk NMIBC with CIS ± papillary tumors.   © 2023 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2023 ASCO-GU Annual Meeting. All rights reserved.