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
Robert Hugh Jones, MD, PhD, of Cardiff University and Velindre Hospital, discusses results from an updated analysis of the FAKTION trial, which showed improved overall survival with fulvestrant plus capivasertib in women with metastatic estrogen receptor–positive breast cancer whose disease had relapsed or progressed on an aromatase inhibitor. The benefit may be predominantly in patients with PIK3CA/AKT1/PTEN pathway–altered tumors, a topic researchers continue to study in the phase III CAPItello-291 trial (Abstract 1005).
The ASCO Post Staff
Bradley J. Monk, MD, of the University of Arizona College of Medicine and Creighton University School of Medicine, discusses phase III findings from the ATHENA–MONO (GOG-3020/ENGOT-ov45) trial. It showed that rucaparib as first-line maintenance treatment, following first-line platinum-based chemotherapy, improved progression-free survival in patients with ovarian cancer, irrespective of homologous recombination deficiency status (Abstract LBA5500).
The ASCO Post Staff
Jenny S. Guadamuz, PhD, of Flatiron Health, discusses the use of telemedicine services in community oncology clinics for patients initiating treatments for 21 common cancers during the COVID-19 pandemic. Black, uninsured, non-urban, and less affluent patients were less likely to use telemedicine services. Although telemedicine may expand access to specialty care, the proliferation of these services may widen cancer care disparities if equitable access to these services is not ensured, according to Dr. Guadamuz (Abstract 6511).
The ASCO Post Staff
Rami Manochakian, MD, of Mayo Clinic Florida, discusses the phase II findings of the NADIM II trial, which confirmed that, in terms of pathologic complete response as well as the feasibility of surgery, combining nivolumab and chemotherapy was superior to chemotherapy alone as a neoadjuvant treatment for locally advanced, resectable stage IIIA non–small cell lung cancer (Abstract 8501).
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).
