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Bristol Myers' (BMY) Opdivo Combo Gets EU Nod for First-Line RCC

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Bristol-Myers Squibb Company (BMY - Free Report) announced that the European Commission (“EC”) has approved its PD-1 inhibitor Opdivo (nivolumab) in combination with Exelixis’ (EXEL - Free Report) Cabometyx (cabozantinib) for first-line treatment of adult patients with advanced renal cell carcinoma (“RCC”).

The EC nod was based on data from the phase III CheckMate -9ER study which evaluated Opdivo + Cabometyx in the given patient population. Data from the same showed that treatment with Opdivo + Cabometyx led to superior efficacy as compared to Pfizer’s (PFE - Free Report) Sutent (sunitinib) across three key endpoints – progression-free survival which was the primary endpoint, and objective response rate as well as overall survival.

Also, the combo of Opdivo plus Cabometyx was generally well tolerated, with a low rate of treatment-related discontinuations.

Please note that Opdivo in combination with Cabometyx was approved for first-line treatment of patients with advanced RCC in the United States in January this year.

Shares of Bristol Myers have increased 2.8% so far this year against the industry’s decrease of 5.1%.

price chart for BMY


We remind investors that, apart from advanced RCC, Opdivo is approved in several countries for various other cancer indications.

Opdivo generated sales worth $6.9 billion in 2020, reflecting a decrease of 3% year over year. The drug faces stiff competition from Merck’s (MRK - Free Report) Keytruda and Roche’s Tecentriq in key indications.

Please note that Keytruda in combination with Inlyta is also approved for the first-line treatment of patients with advanced RCC. This is likely to be a tough competition for Opdivo in the given market space.

Zacks Rank

Bristol-Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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