Commentary

Video

Dr Tyson on the Phase 3 BOND-003 Trial in BCG-Unresponsive NMIBC With CIS

Mark D. Tyson, II, MD, MPH, discusses findings from the phase 3 BOND-003 trial in BCG-unresponsive non–muscle-invasive bladder cancer with CIS.

Mark D. Tyson, II, MD, MPH, a urologic oncologist at Mayo Clinic, discusses findings from the phase 3 BOND-003 trial (NCT04452591) in patients with high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS).

BOND-003 was an open-label, single-arm study of cretostimogene grenadenorepvec in patients with high-risk BCG-unresponsive NMIBC with CIS. At the April 1, 2024, data cutoff, efficacy-evaluable patients (n = 105) achieved a complete response (CR) rate of 75.2% (95% CI, 65%-83%). Tyson noted that beyond the CR findings, treatment with cretostimogene conferred durable responses; 53.8% of patients who received repeat induction converted to CR. Additionally, 29 patients experienced a duration of response (DOR) of at least 1 year, including 14 patients with a DOR of at least 21 months.

The primary end point of the trial is CR rate at any time. Secondary end points include 12-month CR rate, DOR, progression-free survival, cystectomy-free survival (CFS), and safety.

BOND-003 enrolled a total of 112 patients from North America and the Asia-Pacific region. Eligible patients needed to be at least 18 years old, have pathologically confirmed high-risk NMIBC with carcinoma in situ with or without Ta/T1 disease that is unresponsive to BCG, and have an ECOG performance status of 2 or less.

At baseline, most patients were White (61%), male (74%), and more than 65 years old (83%). The median age was 74 years (range, 43-90) and the median number of previous BCG installations was 12 (range, 7-66).

Regarding safety, no grade or higher 3 treatment-related adverse effects (TRAEs) occurred and there were no deaths. Any-grade TRAEs were reported in 62.5% of patients; the most common TRAEs were bladder spasm (23.2%), pollakiuria (19.6%), dysuria (15.2%), micturition urgency (15.2%), and hematuria (14.2%). Serious adverse effects (AEs) consisted of cystitis (1.8%) and clot retention (1.8%) and 1 patient discontinued treatment due to an AE unrelated to treatment. Nearly all (94.5%) patients completed treatment.

Related Videos
Shella Saint Fleur-Lominy, MD, PhD
Benjamin Levy, MD
Nader Sanai, MD, chief, Neurosurgical Oncology, director, Ivy Brain Tumor Center, Barrow Neurological Institute
Manali Kamdar, MD
Ibrahim Aldoss, MD
Barbara Burtness, MD
Natalia Neparidze, MD
Arya Mariam Roy, MBBS
Pamela L. Kunz, MD, associate professor, internal medicine (medical oncology), Yale School of Medicine; director, Center for Gastrointestinal (GI) Cancers, chief, GI Medical Oncology, Smilow Cancer Hospital, Yale Cancer Center
Matthew Matasar, MD, chief, Division of Blood Disorders, Rutgers Cancer Institute; professor, medicine, Rutgers Robert Wood Johnson Medical School