Shots:

• The approval is based on P-I/II CheckMate -040 study assessing Opdivo (1 mg/kg- IV) + Yervoy (3 mg/kg- IV) q3w for four doses- followed by Opdivo (240mg- q2w) in 49 patients with HCC prior treated with sorafenib
• The P-I/II CheckMate -040 study results: @28mos. follow-up- 33% of patients respond to combination therapy; CR (8%); PR (24%); DOR (4.6 to 30.5+ mos.) with 88% lasting at least 6mos.- 56% at least 12mos. and 31% @24 mos.
• Opdivo + Yervoy is the first and only dual immunotherapy approved in this setting and has received FDA’s BT & PR designation for the same indication

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Ref: BMS | Image: BMS