Abstract 420P
Background
The quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis using 4-year follow-up CM 649 data among all randomized patients (pts) on nivolumab plus chemotherapy (NIVO+chemo) demonstrated statistically significant and clearly clinically important gain in quality-adjusted survival of 3.4 months vs chemotherapy (chemo) in advanced GC/GEJC/EAC (Lin et al, 2024). Here, we present updated analyses among PD-L1 CPS pt subgroups.
Methods
Overall survival (OS) was partitioned into 3 mutually exclusive health states: time with grade 3/4 toxicity after randomization and before progression, time without symptoms of disease progression or toxicity, and time from relapse or progression until death. Q-TWiST was calculated as the average time spent in each state, weighted by state-specific quality-of-life utility. In sensitivity analysis (SA), utility values derived from the trial’s treatment-specific UK EQ-5D-3L scores reported during each state were used. Relative Q-TWiST gains were calculated by dividing the difference of NIVO+chemo vs chemo by the mean OS in chemo. Relative gains ≥ 15% were considered clearly clinically important (Solem et al, 2018).
Results
NIVO+chemo pts with CPS≥5 had a mean Q-TWiST gain of 5.4 (95% CI: 3-7.7) months compared with chemo, translating to 33.4% relative gain; the Q-TWiST gain of NIVO+chemo over chemo improved to 6.1 months (37.6% relative gain) in SA. Among pts with CPS≥1, NIVO+chemo had a mean Q-TWiST gain of 4.2 (95% CI: 2.4-6.1) months compared with chemo, translating to 26.1% relative gain. In SA in CPS≥1, the Q-TWiST gain of NIVO+chemo over chemo improved to 4.6 months (28.4% relative gain). Relative gain benefit of NIVO+chemo over chemo remained clearly clinically important for CPS≥5 (26.4%) and CPS≥1 (20.3%) even after including grade 2 adverse events.
Conclusions
After a minimum of 4 years follow-up, results continue to demonstrate the clearly clinically important long-term benefit of NIVO+chemo vs chemo in 1L advanced GC/GEJC/EAC pts with PD-L1 CPS≥1 and CPS≥5.
Clinical trial identification
NCT02872116.
Legal entity responsible for the study
The authors.
Funding
Bristol Myers Squibb.
Disclosure
D. Lin: Financial Interests, Personal, Advisory Role: Exelixis/Ipsen, AstraZeneca, Exelixis; Financial Interests, Personal, Stocks/Shares: BioNano Genomics. W. Quan, M. Garretson,V.V. Chirikov: Financial Interests, Personal, Full or part-time Employment: OPEN Health; Financial Interests, Institutional, Funding: Bristol Myers Squibb. C. Chen: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb, AstraZeneca; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. P. Singh: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. C. Davis: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. All other authors have declared no conflicts of interest.