Background: Historically, 5-y overall survival (OS) with chemotherapy for pts with metastatic lung cancer was ~5%; with the advent of immunotherapy, this has increased to ~15%. CheckMate (CM) 017, 057, 063, and 003 are NIVO studies with extensive follow-up in pts with previously treated advanced NSCLC. Using pooled data from these studies, we evaluated the long-term benefit (up to 4 y) of NIVO and impact of early response or disease control on subsequent long-term OS.

Methods: Progression-free survival (PFS) and OS were estimated for pts with NSCLC across histologies treated with NIVO in pooled analyses of CM 017, 057, 063, and 003 (n=664), and for pts randomized to NIVO (n=427) or docetaxel (DOC; n=427) in pooled analyses of CM 017/057. Other analyses for CM 017/057 included estimation of OS in pts alive at 6 mo by response status at 6 mo, and OS in all responders (complete or partial response [CR/PR]) from time of response.

Results: In pooled analyses of the 4 studies, 4-y OS rates for NIVO in all pts and those with PD-L1 ≥1% and <1% were 14%, 19%, and 11%, respectively. In CM 017/057, the 4-y OS rate in all pts was higher with NIVO vs DOC (14% vs 5%). Pts with either CR/PR or stable disease (SD) at 6 mo had longer subsequent OS with NIVO vs DOC; for pts with PD at 6 mo, 1-y OS rates were higher with NIVO vs DOC, while 2-4 y OS rates were similar (Table). For responders (CR/PR) in CM 017/057, 4-y OS rate from time of response with NIVO vs DOC was 54% vs 12%; median duration of response was 24 mo vs 6 mo, respectively. Overall, the NIVO discontinuation rate due to treatment-related adverse events (AEs) was 8.7%; most common treatment-related select AEs were skin reactions (incidence rate, 38.6 per 100 person-y).

Conclusions: These large pooled analyses show pts with CR/PR or SD with NIVO at 6 mo derived marked OS benefit; this long-term benefit was improved vs pts with DOC with the same response status at 6 mo. The NIVO safety profile was consistent with prior reports.

Table.

6-Month Landmark Analysis of OS by Response Status at 6 months in Pooled CM 017/057a

Pts alive at mo 6 Response status at 6 mo, %b Post-landmark 1-y OS rate, % Post-landmark 2-y OS rate, % Post-landmark 3-y OS rate, % Post-landmark 4-y OS rate, % 
NIVO 3 mg/kg Q2W (n = 280) CR/PR, 25 81 63 61 58 
 SD, 24 58 35 24 19 
 PD, 51 40 13 
DOC 75 mg/m2 Q3W (n = 264) CR/PR, 13 62 38 26 12 
 SD, 39 35 18 
 PD, 48 22 12 
Pts alive at mo 6 Response status at 6 mo, %b Post-landmark 1-y OS rate, % Post-landmark 2-y OS rate, % Post-landmark 3-y OS rate, % Post-landmark 4-y OS rate, % 
NIVO 3 mg/kg Q2W (n = 280) CR/PR, 25 81 63 61 58 
 SD, 24 58 35 24 19 
 PD, 51 40 13 
DOC 75 mg/m2 Q3W (n = 264) CR/PR, 13 62 38 26 12 
 SD, 39 35 18 
 PD, 48 22 12 

aThe 6-month landmark timepoint was used to allow sufficient time for the majority of responses with NIVO to occur, while allowing meaningful time to assess OS post landmark: median time to response, 2.1 mo; 75th quartile, 3.5 mo.

b% of pts alive at 6 mo.

Citation Format: Julie Brahmer, Hossein Borghaei, Suresh S. Ramalingam, Leora Horn, Esther Holgado, Adam Pluzanski, Marco A. Burgio, Marina Garassino, Laura Q. Chow, Scott Gettinger, Lucio Crino, David Planchard, Charles Butts, Alexander Drilon, Joanna Wojcik-Tomaszewska, Gregory Otterson, Vinny Hayreh, Ang Li, John R. Penrod, Scott J. Antonia. Long-term survival outcomes with nivolumab (NIVO) in pts with previously treated advanced non-small cell lung cancer (NSCLC): Impact of early disease control and response [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT195.