The approval is based on P-III study (CheckMate –816) data that evaluated Opdivo (360mg) + CT (Q3W for 3 cycles) vs CT alone. in which Opdivo + CT showed improvement in 1EP (mEFS & pCR) and 2EP (OS)
At 21mos. follow-up in all-randomized patients (n=358), mEFS was (31.6mos. vs (20.8mos.) and pCR was (24% vs 2.2%). OS showed a reduction in the risk of death by 43% vs CT alone. The safety profile was consistent with previously reported studies in NSCLC
Opdivo is a PD-1 ICI, tackle the body’s immune system to help restore anti-tumor immune response across multiple cancers
Ref: BMS | Image: BMS
Related News:- Ono Pharmaceutical’s Opdivo (nivolumab) + Yervoy (ipilimumab) Receives the MFDS Approval as 1L Treatment of Esophageal Squamous Cell Carcinoma in South Korea
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