Karim Chamie, MD, on Bladder Cancer: Final Results on N-803 and Bacillus Calmette-Guérin
2022 ASCO Annual Meeting
Karim Chamie, MD, of the University of California, Los Angeles, discusses final clinical results on combining the superagonist N-803 with bacillus Calmette-Guérin (BCG) in patients whose carcinoma in situ and high-grade non–muscle-invasive bladder cancers are unresponsive to BCG alone. Of note, cystectomy was avoided in more than 90% of patients with 2 years of follow-up (Abstract 4508).
Transcript
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
So, patients with high-grade BCG unresponsive bladder cancer have limited treatment options. They often are offered either a radical cystectomy, which is a life altering operation which involves removal of the entire bladder and the surrounding organs, or treatments with systemic immunotherapies, such as pembrolizumab. With the QUILT-3032 study, what we did was we utilized intravesical IL-15 super-agonists in combination with BCG for patients with BCG-unresponsive bladder cancer. It's a phase two, phase three single arm study in which we enrolled 84 patients with CIS, plus or minus papillary disease, and an additional 77 patients with papillary disease only. Patients received 50 mg of BCG plus 400 mcg of N-803. This was done intravascularly once a week for six weeks, followed by three weekly treatments, similar to SWAG protocols. Our primary endpoint was safety and efficacy. Specifically, as far as efficacy, it was complete response rate at any time, and durability, which meant watching patients respond to therapy and median duration. What we found was that 71% of patients with carcinoma in situ responded at any time, and the median duration of that response was 26.2 months. Which is a phenomenal finding, because patients now have the option of being able to have intravesical therapy and maintaining their bladder for at least two years in this cohort. This compares favorably to checkpoint inhibitors, such as pembrolizumab, where they found 41% of patients had a complete response rate at any time, and the median duration of that response was about a year. The BLA for this treatment, namely N-803 plus BCG, was submitted and we hope to attain approval of this vitally important drug for this critically unmet need and frail cohort of patients.
The ASCO Post Staff
Carryn M. Anderson, MD, of the University of Iowa Hospital, discusses phase III results of the ROMAN trial of avasopasem manganese for patients with severe oral mucositis who are receiving chemoradiotherapy for locally advanced, nonmetastatic head and neck cancer. Compared with placebo, avasopasem manganese improved severe oral mucositis (Abstract 6005).
Paul G. Richardson, MD, of Dana-Farber Cancer Institute, discusses phase III findings from the DETERMINATION trial, which showed that, for patients with newly diagnosed multiple myeloma, lenalidomide, bortezomib, and dexamethasone (RVd) with or without autologous stem cell transplant (ASCT) and lenalidomide maintenance to disease progression resulted in the longest median progression-free survival reported for each approach, and a highly significant difference in progression-free survival in favor of early transplant. While overall response rates were similar, rates of MRD favored early transplant also, but toxicity was greater and quality of life was transiently but significantly diminished. No overall survival advantage has been observed to date (Abstract LBA4).
The ASCO Post Staff
Ursula A. Matulonis, MD, of Dana-Farber Cancer Institute, and Ignace Vergote, MD, PhD, of Belgium’s University Hospitals Leuven, discuss interim safety and efficacy results from a third dose-expansion cohort evaluating first-line tisotumab vedotin-tftv plus pembrolizumab in patients with recurrent or metastatic cervical cancer. Data on the combination showed durable antitumor activity with a manageable safety profile (Abstract 5507).
The ASCO Post Staff
Ann H. Partridge, MD, MPH, of Dana-Farber Cancer Institute, and Kevin Kalinsky, MD, of Winship Cancer Institute at Emory University, discuss phase II findings from the MAINTAIN trial, which showed a benefit in progression-free survival for patients with hormone receptor–positive/HER2-negative metastatic breast cancer when they switched to endocrine therapy and received ribociclib after disease progression on another CDK4/6 inhibitor (Abstract LBA1004).
The ASCO Post Staff
Alicia K. Morgans, MD, MPH, of Dana-Farber Cancer Institute, and Ian D. Davis, PhD, MBBS, of Monash University and Eastern Health, discuss the latest findings from ANZUP Cancer Trials Group’s ENZAMET cooperative group trial of enzalutamide in patients with metastatic hormone-sensitive prostate cancer. The results corroborate the benefit of enzalutamide with improved overall survival, and involve some exploratory subgroup analyses (Abstract LBA5004).
