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
Sriram Yennu, MD, of The University of Texas MD Anderson Cancer Center, discusses the placebo response in patients with advanced cancer and cancer-related fatigue. His latest findings show that open-labeled placebo was efficacious in reducing cancer-related fatigue and improving quality of life in fatigued patients with advanced cancer at the end of 1 week. The improvement in fatigue was maintained for 4 weeks (Abstract 12006).
The ASCO Post Staff
Ursula A. Matulonis, MD, of Dana-Farber Cancer Institute, and Domenica Lorusso, MD, PhD, of Italy’s Gemelli University Hospital, discuss phase III data from the MITO23 trial on single-agent trabectedin vs clinician’s choice of chemotherapy in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancers of BRCA-mutated or BRCAness phenotype. Although trabectedin has demonstrated antitumor activity in relapsed platinum-sensitive disease, it does not appear to improve survival outcomes when compared with standard chemotherapy in the BRCA-mutated population (Abstract LBA5504).
The ASCO Post Staff
Georgina V. Long, MD, PhD, of the Melanoma Institute Australia, The University of Sydney, discusses phase III findings from the KEYNOTE-716 study. The trial showed that compared with placebo, adjuvant pembrolizumab significantly improved distant metastasis–free survival in patients with resected stage IIB and IIC melanoma. The findings also suggest a continued reduction in the risk of recurrence and a favorable benefit-risk profile (Abstract LBA9500).
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
Shilpa Gupta, MD, of the Cleveland Clinic Foundation, discusses an updated consensus definition for standard therapy and clinical trial eligibility for patients with metastatic urothelial cancer who are platinum-ineligible, criteria that are proposed to guide treatment recommendations for this population. This may be especially important now that the U.S. Food and Drug Administration has restricted the use of first-line pembrolizumab to those who are considered platinum-ineligible (Abstract 4577).
