ASCO GU 2019: Discussion on: The KEYNOTE-426 Study and the Subgroup Analysis from the JAVELIN Renal 101

San Francisco, CA (UroToday.com) In this session, Dr. Wood analyzed KEYNOTE 426 and JAVELIN Renal 101, placing the data into clinical context.  The European Association of Urology 2018 guidelines strongly recommends sunitinib or pazopanib for favorable risk advanced renal cell carcinoma (aRCC) as first-line therapy and cabozantinib or nivolumab as 2nd line therapy.  In patients with intermediate or poor risk disease, strong recommendations are made for ipilimumab/nivolumab in the first line and cabozantinib or VEGF inhibitor or nivolumab as 2nd line.  In 2018, the Checkmate 214 and ImMotion 151 clinical trials released data supporting combination therapies (ipilimumab + nivolumab or and atezolizumab + bevacizumab). 

Dr. Wood stated that KEYNOTE 426 and JAVELIN Renal 101 are practice-changing studies and support alterations in 1st line treatment recommendations. Reviewing JAVELIN Renal 101, Dr. Wood summarized that improved progression-free survival and overall response rates were seen in all subgroups (risk, PD-L1 status, prior nephrectomy status, smoking status, BMI).  However, overall survival data is presently pending.  KEYNOTE 426 also demonstrated an improvement in overall survival, progression-free survival, and overall response rates in the entire study population.  Similarly, the benefit was demonstrated in all subgroups as well.

Dr. Wood states this data supports a new standard of care in 2019 for advanced clear cell RCC.  Nevertheless, clinicians must decide which treatment combination to choose by assessing the following: 1) efficacy, 2) tumor/patient characteristics, 3) toxicities, 4) cost and drug access, 5) logistics, and 6) perspective.  Significant work needs to be done in this space to assess the utilization of resources (cost, clinic space, infusion time, etc.) that these combination regimens require.  In addition, concerns regarding the significant burden of time are placed on physicians, nurses, pharmacy staff, and the patient exist.  It is currently unclear whether we can safely deliver the medications to all patients.  Improvement in patient education, selection, and clinical logistics is essential. 

Future studies with various two or three-drug combinations are in the works.  Given the new CARMENA data, clinicians also have to uncover whether cytoreduction is necessary for improved outcomes in this population.  We look forward to practice changing studies like these, but need to work together to implement these drugs into clinical practice!


Presented by: Lori Wood, MD, FRCPC, Institution: Dalhousie University, Halifax, Novia Scotia

Written by: David B. Cahn, DO, MBS, @dbcahn, Fox Chase Cancer Center at the Annual ASCO GU meeting 2019, San Francisco, CA, Twitter: @shekabhishek at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA
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