MedicalResearch.com Interview with:
Prof. Michael B. Atkins, MD
Deputy Director, Georgetown-Lombardi Comprehensive Cancer Center
William M. Scholl Professor and Vice-Chair Department of Oncology and
Professor of Medicine
Georgetown University Medical Center
MedicalResearch.com: What is the background for this study?
Response: Prior studies combining programmed death-1 (PD-1) checkpoint inhibitors with tyrosine kinase inhibitors of the vascular endothelial growth factor (VEGF)-pathway have been characterized by excess toxicity precluding further development. We hypothesized that axitinib, a more selective VEGF inhibitor would combine safely with pembrolizumab (anti-PD-1) and yield antitumour activity in treatment-naïve patients with advanced renal cell carcinoma.
MedicalResearch.com: What are the main findings?
Response: 52 treatment-naïve patients with advanced renal cell carcinoma enrolled. No unexpected toxicities were observed. The regimen showed unprecedented anti-tumor activity in patients with advanced clear cell RCC with a 73.1% response rate, > 90% tumor shrinkage, median PFS was 20.9 months, and median OS was not reached with only 6 deaths noted within the first 18 months.
MedicalResearch.com: What should readers take away from your report?
Response: The axitinib + pembrolizumab combination is well tolerated and produced significant anti-tumor effects in patients with advanced clear cell renal cell carcinoma. However this study involved a relatively favorable risk patient population and the design of the study did not allow for examining “treatment free survival” so it is unclear to what extent these results are represent and enhanced immune response vs simply additive effects of two distinct treatment approaches. Therefore the true value of this regimen must await the completion of the phase III trial (KN426) comparing this regimen to sunitinib monotherapy.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Complete the KN426 Phase III trial. Would be useful to also have a study comparing this regimen to the nivo + ipi combination.
Disclosures: Consultant for BMS, Merck, Pfizer, Novartis, Genentech, Exelixis and Eisai.
Axitinib in combination with pembrolizumab in patients with advanced renal cell cancer: a non-randomised, open-label, dose-finding, and dose-expansion phase 1b trial
Prof Michael B Atkins, MD, Elizabeth R Plimack, MD, Prof Igor Puzanov, MD, Prof Mayer N Fishman, MD, Prof David F McDermott, MD, Daniel C Cho, MD, Prof Ulka Vaishampayan, MD, Saby George, MD, Thomas E Olencki, DO, Jamal C Tarazi, MD, Brad Rosbrook, MS, Kathrine C Fernandez, MD, Mariajose Lechuga, MD, Toni K Choueiri, MD
Published: 10 February 2018
Lancet Oncology DOI: https://doi.org/10.1016/S1470-2045(18)30081-0
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