RCC [2017]: Bulletin #1
This edition presents key opinion leader (KOL) views on recent developments in the renal cell carcinoma (RCC) market. Topics covered include; data released from Bristol-Myers Squibb’s Phase III CheckMate-214 study, comparing Opdivo (nivolumab) in combination with ipilimumab (Yervoy) versus Sutent (sunitinib; Pfizer) in intermediate and poor-risk patients with previously untreated advanced or metastatic RCC;Exelixis and Bristol-Myers Squibb’s initiation of the Phase III CheckMate 9ER trial to evaluate Opdivo in combination with Cabometyx (cabozantinib), or Opdivo and ipilimumab in combination with Cabometyx, versus Sutent in patients with previously untreated, advanced or metastatic RCC; Exelixis’ filing for US FDA approval of Cabometyx for the treatment of patients with previously untreated advanced RCC, based on data from the Phase II CABOSUN trial.
Business Questions:
Business Questions:
- How do KOLs interpret the findings from the CheckMate-214 trial of Bristol-Myers Squibb’s Opdivo/ipilimumab combination?
- What is the likelihood of favourable OS data coming out of the CheckMate-214 trial?
- Does the Opdivo/ipilimumab combination have potential in the treatment of intermediate and poor-risk patients with previously untreated advanced or metastatic RCC, and what are the expectations for use?
- To what extent will tolerability issues affect the likely potential of Opdivo/ipilimumab/Cabometyx and Opdivo/ipilimumab combination regimens in patients with previously untreated advanced or metastatic RCC?
- What other barriers to standard practice will Opdivo/ipilimumab/Cabometyx and Opdivo/ipilimumab combination regimens face?
- How likely is it that the US FDA will approve Exelixis’ Cabometyx for the treatment of patients with previously untreated advanced RCC, based on data from the Phase II CABOSUN trial?
- What competition will Cabometyx face, if approved for the treatment of previously untreated advanced RCC?