- 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
Click here to read full press release/ article | Ref: BMS | Image: Under Consideration