MedicalResearch.com Interview with:
Dr. Mathew Galsky MD
Associate Professor, Medicine, Hematology and Medical Oncology
Assistant Professor, Urology
Director, Genitourinary Medical Oncology
The Tisch Cancer Institute
Icahn School of Medicine at Mount Sinai
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Since the development of combination cisplatin-based chemotherapy for the treatment of metastatic bladder (urothelial) cancer several decades ago, there have been few advances in the treatment of this disease. Further, until recently, there had been no global standard treatment options for patients with metastatic urothelial cancer progressing despite platinum-based chemotherapy. Several lines of evidence suggest that urothelial cancer may be sensitive to immunotherapeutic treatment strategies. Recently, in a phase I/II study published by Sharma and colleagues in Lancet Oncology, the anti-PD-1 antibody Nivolumab demonstrated a durable objective response rate of 24% in patients with metastatic urothelial cancer progressing despite platinum-based chemotherapy. To confirm to antitumor effects of Nivolumab in this patient population, we conducted a large global multicenter single-arm phase II study
MedicalResearch.com: What should readers take away from your report?
Response: The primary analysis revealed in in this large study including 265 treated patients, compared with a historical control response rate of 10% with chemotherapy, Nivolumab was associated with a clinically meaningful objective response rate of 19.6% as determined by a blinded independent review committee. Importantly, as has been seen with immune checkpoint blockade in other malignancies, responses were durable. While higher expression of PD-L1 on tumor cells as assessed by immunohistochemistry was associated with an increase response rate with Nivolumab, the lower bound of the 95% confidence interval exceeded 10% even in patients with low to no tumor PD-L1 expression. There were no new safety signals and quality of life was maintained in patients remaining on treatment long term.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Based on the results of this study, the EMA initiated official review in September 2016, and the FDA granted Breakthrough Therapy Designation in June 2016, for a potential indication for Nivolumab as treatment for patients with metastatic urothelial cancer progressing despite platinum-based chemotherapy.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
ESMO 2016 abstract:
Second-line metastatic urothelial carcinoma treatment and survival in real-world patients in the US
S.K. Pal1, M.D. Galsky2, S-W. Lin3, S. Ogale3, M. Zivkovic4, J. Simpson3, C. Derleth3, G. Sonpavde5 1 Medical Oncology and Experimental Therapeutics, City of Hope, Duarte, CA, USA, 2 Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA, 3 Health Economics & Outcomes Research, Genentech, Inc., South San Francisco, CA, USA, 4 Oncology, Genesis Research, Hoboken, NJ, USA, 5 Medical Oncology
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