Renal Cell Carcinoma: Update Bulletin # 3 [March 2019]

This edition presents the views and insights from three of the world's foremost key opinion leaders (KOLs) from the US and EU on a variety of recent events in the renal cell carcinoma (RCC) market, including: the FDA awarding Priority Review for a new supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab; Merck & Co.) in combination with Inlyta (axitinib; Pfizer) for the first-line treatment of patients with advanced RCC, based on findings from the KEYNOTE-426 trial; the EU approval of Opdivo (nivolumab; Bristol-Myers Squibb [BMS]) in combination with Yervoy (ipilimumab; BMS) for the first-line treatment of patients with intermediate- and poor-risk advanced RCC, based on data from the CheckMate-214 study; updated findings from the CheckMate-214 trial of Opdivo plus low-dose Yervoy presented at ASCO GU 2019.

Business Questions:

• How do KOLs interpret data from the KEYNOTE-426 trial of Keytruda in combination with Inlyta for the first-line treatment of patients with advanced RCC? Are there any caveats to these findings?
• How is the safety and tolerability of Keytruda/Inlyta viewed and is it a price worth paying for its efficacy?
• What role will Keytruda/Inlyta play in the treatment of advanced RCC?
• How do KOLs react to the EU approval of Opdivo/Yervoy and what role does it already play in the US?
• What are KOL reactions to the 30-month follow-up data from the CheckMate-214 trial of Opdivo/Yervoy that were presented at ASCO GU 2019?
• In light of the FDA Priority Review secured for Keytruda/Inlyta, and the US and EU approvals of Opdivo/Yervoy, how do KOLs rate prospects for avelumab in combination with Inlyta to find a role in the treatment of RCC?