Abstract 140P
Background
In ORIENT-12 trial, sintilimab plus gemcitabine and platinum provided a significant and clinically meaningful PFS improvement comparing to placebo plus gemcitabine and platinum in Chinese patients with advanced/metastatic squamous NSCLC. This abstract summarizes PRO results.
Methods
357 participants were randomized (179 in sintilimab and 178 in placebo arm). PRO was assessed using LCSS and QLQ-C30 before the first dose, at each imaging evaluation and end-of-treatment visit. Clinically meaningful differences were defined as ≥10 points on a 0-100 scale, except for LCSS three-item global index (3-IGI; ≥30 points). Deterioration was defined as the onset of ≥10-point increase from baseline. P-value <0.05 was considered statistically significant.
Results
PRO compliance rates maintained high until week 30. Baseline scores for each item were similar between arms. During the overall treatment period, QLQ-C30 scores were maintained regardless of the addition of sintilimab [Least square mean changes from baseline (95%CI): sintilimab: -1.04 (-3.42, 1.33); placebo: -0.74 (-3.33, 1.85); Between-group difference (95%CI): -0.30 (-3.81, 3.22)]; LCSS total score, 3-IGI, and average symptom burden index were maintained for both groups. LCSS composite endpoint and respiratory symptoms endpoint showed statistically significant improvement at week 6 and 12 for both arms, but changes did not reach a clinically meaningful difference. Sintilimab arm showed a numerical trend towards delayed deterioration across most LCSS and QLQ-C30 items. Notably, sintilimab arm showed significantly delayed in pain and major symptoms in QLQ-C30, as well as blood in sputum (Median: 56.9 vs 44.9 weeks, HR: 0.56; 95% CI: 0.37, 0.84, p=0.006) and painful sensations (Median: 49.1 vs 44.0 weeks, HR: 0.65; 95% CI: 0.44, 0.95, p=0.027) in LCSS.
Conclusions
The addition of sintilimab to chemotherapy treatment maintained the quality-of-life and delayed the main symptoms deterioration compared to placebo. The data support sintilimab plus platinum and gemcitabine as first-line treatment for advanced/metastatic squamous NSCLC.
Clinical trial identification
NCT03629925.
Legal entity responsible for the study
Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai, People's Republic of China.
Funding
Lilly Suzhou Pharmaceutical Co. Ltd., Shanghai, People's Republic of China.
Disclosure
C. Zhou: Financial Interests, Personal, Invited Speaker: Roche China, Lilly China, Sanofi, C-Stone, Qilu, Hengrui, Innovent Biologics, TopAlliance Bioscience Inc, Amoy Diagnoistics, BI. All other authors have declared no conflicts of interest.