Advertisement


Karim Chamie, MD, on Bladder Cancer: Final Results on N-803 and Bacillus Calmette-Guérin

2022 ASCO Annual Meeting

Advertisement

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.

Related Videos

Sarcoma

Martin McCabe, PhD, on Ewing Sarcoma: Assessment of Topotecan, Cyclophosphamide, and High-Dose Ifosfamide

Martin McCabe, PhD, of the University of Manchester, discusses a phase III assessment of chemotherapy for patients with recurrent and primary refractory Ewing sarcoma. The trial, called rEECur, is the first study to provide comparative toxicity and survival data for the four most commonly used chemotherapy regimens in this disease. The analysis showed that high-dose ifosfamide is more effective in prolonging survival than topotecan plus cyclophosphamide (Abstract LBA2).

Prostate Cancer

Alicia K. Morgans, MD, MPH, and Ian D. Davis, PhD, MBBS, on Prostate Cancer: Updated Overall Survival Outcomes With Enzalutamide

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).

Lung Cancer

Maxwell Oluwole Akanbi, MD, PhD, on Lung Cancer: The Effect of Screening on the Incidence of Advanced Disease

Maxwell Oluwole Akanbi, MD, PhD, of McLaren Regional Medical Center, discusses the study he conducted, using the SEER database, to evaluate the impact of lung cancer screening recommendations on low-dose CT scanning. The data suggest that guidelines from the U.S. Preventive Services Task Force led to a more rapid decline in the incidence of advanced disease in the United States, especially among minority populations (Abstract 10506).

Skin Cancer
Immunotherapy

Georgina V. Long, MD, PhD, on Melanoma: Distant Metastasis–Free Survival With Adjuvant Pembrolizumab

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).

Lung Cancer
Immunotherapy

Gilberto de Lima Lopes, Jr, MD, MBA, and Karen L. Reckamp, MD, on NSCLC: Overall Survival Results With Ramucirumab Plus Pembrolizumab vs Standard of Care

Gilberto de Lima Lopes, Jr, MD, MBA, of the Sylvester Comprehensive Cancer Center at the University of Miami, and Karen L. Reckamp, MD, of Cedars-Sinai Medical Center, discuss phase II findings from substudy S1800A of the Lung-MAP protocol. The data showed that ramucirumab and pembrolizumab improved overall survival compared with the standard of care for patients with advanced non–small cell lung cancer who were previously treated with immunotherapy and platinum-based chemotherapy (Abstract 9004).

 

Advertisement

Advertisement




Advertisement