25P Patient-reported outcomes (PROs) with coformulated vibostolimab/pembrolizumab (vibo/pembro) for metastatic cervical cancer (CC): Results from the KEYVIBE-005 study

In the multicohort phase 2 KEYVIBE-005 study (NCT05007106), first-line vibo/pembro (n = 85) showed antitumor activity similar to pembro (n = 84; ORR, 20.0% vs 15.5%) with a manageable safety profile in patients (pts) with metastatic CC with PD-L1 CPS ≥1. We report prespecified PRO end points. Pts ≥18 y with previously untreated locally recurrent or metastatic CC with PD-L1 CPS ≥1 were randomly assigned 1:1 to vibo 200 mg/pembro 200 mg or pembro 200 mg IV Q3W for ≤35 cycles. Prespecified PRO end points were least squares mean (LSM) change from baseline (BL) to wk 12 in EORTC QLQ-C30 global health status/quality of life (GHS/QoL) and physical functioning (PF) subscales, EORTC QLQ-CX24 symptom experience subscale, and EQ-5D-5L VAS health status score; within-pt changes of 10 points were considered clinically meaningful for QLQ-C30 and QLQ-CX24 measures. PRO assessments were performed at every cycle before treatment and evaluated in pts who received ≥1 dose of study treatment and completed ≥1 postbaseline PRO assessment. The PRO population comprised 166 pts (n = 85; vibo/pembro; n = 81; pembro). At wk 12, completion and compliance rates for both treatment groups were ≥64% and ≥86%, respectively, for all assessments. LSM change and 95% CIs from BL to wk 12 for all scales are reported in the table. Pts in both groups experienced small changes in EORTC QLQ-C30 GHS/QoL and PF, EORTC QLQ-CX24 symptom experience, and EQ-5D-5L scores, with overlapping CIs. None of the group differences were clinically meaningful.Table: 25PLeast squares mean change from baseline to week 12PRO ScaleVibo/pembro n = 85 LSM (95% CI)Pembro n = 81 LSM (95% CI)Difference (95% CI)EORTC QLQ-C30Global health status/quality of lifea0.77 (–3.84 to 5.38)3.53 (–1.13 to 8.20)–2.76 (–8.81 to 3.29)Physical functioninga–3.58 (–8.29 to 1.14)–3.14 (–7.96 to 1.68)–0.44 (–7.07 to 6.19)EORTC QLQ-CX24Symptom experienceb0.27 (–2.74 to 3.27)–2.99 (–6.04 to 0.05)3.26 (–0.61 to 7.13)EuroQol 5D-5L VASa1.86 (–2.52 to 6.24)2.23 (–2.18 to 6.64)–0.37 (–6.20 to 5.46)aHigher values indicate improvement. bHigher values indicate worsening. Open table in a new tab aHigher values indicate improvement. bHigher values indicate worsening. These are the first PRO results from the KEYVIBE-005 study in which pts with previously untreated metastatic CC with PD-L1 CPS ≥1 were randomly assigned to vibo/pembro vs pembro. For all PRO assessments, the change from BL to wk 12 with vibo/pembro was similar to pembro alone; thus, vibo/pembro did not negatively impact health-related QoL in this pt population.