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Renal Cell Carcinoma: Update Bulletin #1 [September 2018]

Product Code:
Publication Date:
September 2018

This edition presents key opinion leader (KOL) views on recent developments in the Renal Cell Carcinoma (RCC) market. Topics covered include: Merck & Co. presenting data from the Phase II KEYNOTE-427 trial, evaluating  Keytruda (pembrolizumab) as first-line monotherapy for patients with locally advanced or metastatic RCC; Eisai and Merck & Co. presenting data from the Phase Ib/ll Study 111/ KEYNOTE-146 trial evaluating Keytruda plus Eisai’s Lenvima/Kisplyx (lenvatinib) for the treatemt of advanced RCC; Pfizer presenting data from the Phase III CARMENA trial assessing the benefits of cytoreductive nephrectomy (CN) prior to the administration of Sutent (sunitinib), compared with Sutent alone; BMS reporting that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) would be recommending against the approval of the combination of Opdivo (nivolumab) with Yervoy (ipilimumab) for the first-line treatment of RCC.

Business Questions:

• Do the interim data from the KEYNOTE-427 trial fully demonstrate Keytruda’s efficacy as a first-line treatment for patients with advanced RCC, or will further study be required to confirm this?
• How important is PD-L1 expression as a predictive biomarker for identifying appropriate patients for monotherapy with Keytruda in the first-line RCC setting?
• On the basis of the KEYNOTE-146 data, how do KOLs rate the combination of Keytruda with Lenvima/Kisplyx in terms of efficacy and safety?
• Are the Phase Ib/II KEYNOTE-146 data adequate for assessing Keytruda plus Lenvima/Kisplyx’s potential role within the advanced RCC setting, or will additional trial data be required to establish this?
• Can any conclusions be drawn regarding the benefits of Sutent monotherapy, compared with cytoreductive nephrectomy followed by Sutent, on the basis of the CARMENA trial data?
• Which types of patient are most likely to benefit from Sutent monotherapy, and to what extent will Sutent replace surgery, followed by Sutent, in such patients? 
• How do KOLs view the CHMP’s decision not to recommend Opdivo plus Yervoy for approval as a first-line RCC treatment in Europe, and what are the most likely reasons underlying this decision?
• Can KOLs offer any explanation as to why the CHMP and the US FDA have adopted opposing positions regarding the approval of Opdivo/Yervoy in the first-line RCC setting?


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