RCC [2017]: Bulletin #2

This edition presents key opinion leader (KOL) views on recent developments in the renal cell carcinoma (RCC) market. Topics covered include; the early halting of the CheckMate-214 trial and subsequent regulatory applications for Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with ipilimumab (Yervoy), in intermediate-and poor-risk patients with previously untreated advanced or metastatic RCC; the European Medicines Agency (EMA) approval of AVEO Oncology’s Fotivda (tivozanib) in advanced RCC; the US FDA extending the approval of Pfizer’s Sutent (sunitinib) to include the adjuvant treatment of high-risk recurrent RCC, following nephrectomy, based on data from the Phase III S-TRAC trial.

Business Questions:

• How do KOLs view the news of a positive outcome from the CheckMate-214 trial of Opdivo/ipilimumab?
• Do KOLs anticipate that Opdivo/ipilimumab will become a standard of care in intermediate-and poor-risk patients with previously untreated advanced or metastatic RCC?
• What factors are anticipated to impact Opdivo/ipilimumab’s chances of success in the treatment of RCC?
• How do KOLs view Fotivda compared with other available TKIs?
• How will do KOLs view Fotivda’s chances of success in the EU?
• Could Fotivda play a significant role in the future of RCC treatment in the US?
• How do KOLs view the FDA decision to approve Sutent for the adjuvant treatment of high-risk recurrent RCC, following nephrectomy?
• Will Sutent’s toxicity issues be manageable in the adjuvant setting?
• To what extent and in which patients is Sutent expected to be used in the adjuvant setting, and what could help it establish broader use?