Ono Pharmaceutical’s Opdivo (nivolumab) + Yervoy (ipilimumab) Receives the MFDS Approval as 1L Treatment of Esophageal Squamous Cell Carcinoma in South Korea
- The MFDS has approved Opdivo (IV) for unresectable advanced or metastatic ESCC with tumor cell PD-L1 expression ≥ 1% in combination with Yervoy & CT
- The approvals were based on the results from the P-III study (CheckMate -648/ONO-4538-50/CA209648) evaluating Opdivo (3mg/kg, q2w) + Yervoy (1mg/kg, q6w for ~ 24mos.) and Opdivo (240mg, q2w) + CT vs CT alone (fluorouracil and cisplatin combination therapy)
- The combination therapy showed a significant clinical improvement in OS at the pre-specified interim analysis in patients with tumor cell PD-L1 expression ≥1% & an all-randomized patient population. The safety profiles were consistent with prior reported studies
Ref: Ono Pharmaceutical | Image: Ono Pharmaceutical
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