Randomized results of fixed-duration (1-yr) vs continuous nivolumab in patients (pts) with advanced non-small cell lung cancer (NSCLC)

Abstract

Purpose: Nivo has shown durable responses and survival benefit in pts with advNSCLC, with some pts continuing to derive benefit after discontinuation, raising the question of whether continuous treatment is necessary for long‐term benefit. CheckMate 153 (NCT02066636), an ongoing phase 3B/4 study primarily in the community setting, evaluates the benefit of a fixed‐duration (1 y) of nivo treatment vs continuous treatment in pts with previously treated advNSCLC. Methods: Pts with stage IIIB/IV NSCLC and ≥1 prior systemic therapy received nivo 3 mg/kg IV Q2W. The primary endpoint was the incidence of grade 3‐5 treatment related select adverse events. Pts still on treatment at 1 y were randomized 1:1 to continue nivo until progressive disease, unacceptable toxicity, or consent withdrawal (continuous‐treatment arm), or to discontinue treatment with the possibility of resuming treatment upon disease progression (fixed‐duration arm). Prespecified exploratory objectives included safety and efficacy in the 2 randomized arms. Results: As of Apr 2016, 1375 pts were treated; 218 pts were randomized after 1 y of treatment to the continuous‐treatment arm (n = 111) or the fixed‐duration arm (n = 107). Of these 218 pts, 133 (61%) had received ≥2 prior therapies and 10 (5%) had baseline ECOG PS 2. Data from an upcoming database lock (expected post‐randomization follow‐up ≥10.7 mo) will be presented for randomized pts and will include OS, PFS, and safety. Data from pts who were re‐treated in the fixed‐duration arm will be presented. Conclusions: Results from CheckMate 153 represent the first insights from a randomized trial evaluating the impact of stopping treatment with a PD 1/PD‐L1 inhibitor at 1 y vs continuing treatment in pts with previously treated advNSCLC.