Two-year Update From CheckMate 141: Outcomes With Nivolumab (Nivo) vs Investigator's Choice (IC) in Recurrent or Metastatic (R/M) Squamous Cell Carcinoma of the Head and Neck (SCCHN) in the Overall Population and PD-L1 Subgroups

Abstract

Nivo is the only immuno-oncology (I-O) agent to significantly improve overall survival (OS) in patients (pts) with R/M SCCHN who have progressed on or after platinum-based therapy and for whom long-term prognosis has historically been poor (median OS ≤6 mo). Here we report the first long-term (2-yr) data with immune checkpoint inhibition in pts with R/M SCCHN who have progressed on or after platinum-based therapy from the randomized, open-label, phase 3 CheckMate 141 study (NCT02105636). Eligible pts were randomized 2:1 to nivo 3 mg/kg q2wk (n = 240) or IC (methotrexate, docetaxel, or cetuximab; n = 121). The primary endpoint was OS; other endpoints included progression-free survival (PFS) and safety. Minimum follow-up for the current analysis: 24.2 mo (data cut: Sep 2017). 2-yr OS rate (95% CI) was 16.9% (12.4, 22.0) with nivo versus 6.0% (2.7, 11.3) with IC. Nivo continued to improve 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; hazard ratio (HR) [95% CI]: 0.68 [0.54, 0.86]). PFS remained similar between treatment arms. Outcomes by PD-L1 and HPV subgroups are shown in the Table 1. In pts with tumor PD-L1 <1%, risk of death at 2 yrs was reduced by 27% with nivo versus IC with the HR trending lower with longer follow-up; HR (95% CI) = 0.89 (0.54, 1.45), 0.83 (0.54, 1.29), and 0.73 (0.49, 1.09) at 6 mo (May 2016 data cut), 1 yr (Sep 2016 data cut), and 2 yrs of follow-up, respectively. Nivo also continued to improve OS versus IC in pts with tumor PD-L1 ≥ 1%. Grade 3-4 treatment-related adverse events occurred in 15.3% (nivo) versus 36.9% (IC) of pts; toxicity-related deaths in 2 pts (0.8%; pneumonitis and hypercalcemia) and 1 pt (0.9%; treatment-related lung infection), respectively. With longer follow-up (2 yrs), nivo continued to significantly improve OS and maintained a favorable safety profile versus IC in the overall population in CheckMate 141. Nivo is the only I-O therapy to demonstrate OS benefit irrespective of PD-L1 status (<1% and ≥1%) in pts with SCCHN.Abstract LBA10; Table 1Outcomes by PD-L1 expression and HPV statusMedian OS (95% CI), moMedian PFS (95% CI), moNivoICHR (95% CI)NivoICHR (95% CI)PD-L1 < 1%6.5 (4.4, 11.7)5.5 (3.7, 8.5)0.73 (0.49, 1.09)2.0 (1.9, 2.1)2.7 (2.0, 4.6)1.13 (0.75, 1.71)PD-L1 ≥ 1%8.2 (6.7, 9.5)4.7 (3.8, 6.2)0.55 (0.39, 0.78)2.1 (2.0, 3.5)2.0 (1.9, 3.1)0.59 (0.41, 0.84)HPV+9.1 (6.5, 11.8)4.4 (3.0, 9.8)0.60 (0.37, 0.97)2.0 (1.9, 3.3)2.0 (1.6, 2.8)0.75 (0.46, 1.23)HPV−7.7 (4.8, 13.0)6.5 (3.9, 8.7)0.59 (0.38, 0.92)2.1 (1.9, 3.1)3.3 (1.9, 4.0)1.01 (0.65, 1.56) Open table in a new tab