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.

Conclusion

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.