Overall health status (HS) in patients (pts) with advanced (adv) non-squamous (NSQ) NSCLC treated with nivolumab (nivo) or docetaxel (doc) in CheckMate 057

Background

The CheckMate 057 randomized, open-label, phase III study evaluated the efficacy and safety of nivo vs doc in previously-treated pts with adv NSQ NSCLC. Overall survival was significantly improved with nivo vs doc, as were symptoms as assessed by the Lung Cancer Symptom Scale. Here we report the impact of nivo vs doc on overall pt-reported HS.

Methods

The EuroQoL-5 Dimensions visual analog scale (EQ-5D VAS) and EQ-5D utility index (UI) (scaled 0 to 100 and −0.594 to +1, respectively) were assessed every other cycle (Q4W) for nivo and every cycle (Q3W) for doc for the first 6 mo on treatment (tx), then every 6 wks and at 2 post-tx follow-up visits. Changes from baseline (BL) at individual assessments (asmts), a mixed-effects model (MMRM) of change from BL over all on-tx asmts, and time to first deterioration (TTD) in HS were evaluated. The minimally important difference (MID) is ≥7 points for the EQ-5D VAS and ≥0.08 points for the UI.

Results

At on-tx asmts with >10 pts (through wk 78), EQ-5D VAS briefly worsened from BL in nivo pts at wk 4 (MID) at wks 24 and 36. There were no statistically significant changes from BL at any on-tx asmt in EQ-5D VAS scores for doc pts or in EQ-5D UI scores for nivo (apart from a worsening [

Conclusions

The EQ-VAS results from this phase III study showed that nivo pts with previously-treated adv NSQ NSCLC had improvements in on-tx HS while doc pts' on-tx HS was stable. TTD in health status per the EQ-VAS was significantly longer in nivo- vs doc-treated pts.

Clinical trial identification

NCT01673867

Legal entity responsible for the study

Bristol-Myers Squibb

Funding

Bristol-Myers Squibb

Disclosure

M. Reck: Speakers' Bureau and consulting/advisory role for Roche, Lilly, BMS, MSD, AZ, Pfizer, BI, Celgene. J.R. Brahmer: Consulting/Advisory role for Celgene, Lilly, Merck (BMS-uncompensated) and research funding from BMS, MedImmune/AZ, Merck. B. Bennett: Employment from AZ, research funding from Adelphi Values, and consulting/advisory role with Adelphi Values. F. Taylor: Research funding and Consulting or advisory role from Adelphi Values, a consultancy paid by BMS to analyze BMS clinical trial data. J.R. Penrod: Employment and stock options: BMS. H. Dastani: Employment and Stock or Other Ownership from BMS. R. Gralla: Honoraria from Merck and consulting/advisory role with BMS, Merck, Lilly, BI. All other authors have declared no conflicts of interest.