Abstract CT116: Nivolumab (Nivo) vs investigator's choice (IC) in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN): 2 yr outcomes in the …

Aim: Nivo is the only immunotherapy to significantly improve overall survival (OS) in patients (pts) with R/M SCCHN who have progressed on or after platinum-based therapy. Here we report long-term data from the randomized, open-label, phase 3 CheckMate 141 study (NCT02105636).Patients: Pts with R/M SCCHN who progressed on or after platinum-based therapy were randomized 2:1 to nivo 3 mg/kg q2wk (n = 240) or IC (methotrexate, docetaxel, or cetuximab; n = 121). Endpoints: OS (primary), progression-free survival (PFS), safety. Minimum follow-up: 24.2 mo (data cut: Sep 2017).Results: Nivo improved OS significantly vs IC in the overall population (median [95% CI]: 7.7 [5.7, 8.8] mo vs 5.1 [4.0, 6.2] mo; HR [95% CI]: 0.68 [0.54, 0.86]). 2-yr OS rate (95% CI) was 16.9% (12.4, 22.0) with nivo vs 6.0% (2.7, 11.3) with IC. 8.3% of pts in the IC arm received subsequent immunotherapy. Outcomes by PD-L1 and …