HIGH CLEANSING EFFICACY WITH OVERNIGHT SPLIT DOSING 1L NER1006 ACROSS SCREENING, DIAGNOSTIC AND SURVEILLANCE COLONOSCOPY: POST HOC ANALYSIS OF TWO RANDOMISED PHASE 3 CLINICAL TRIALS

Aims We compared, per reason for colonoscopy (screening, surveillance or diagnostic), the cleansing performance of 1L polyethylene glycol NER1006 (PLENVU) versus two preparations.

Methods This post hoc analysis of two phase 3 clinical trials compared the efficacy of pooled PLENVU versus pooled 2L polyethylene glycol plus ascorbate (2LPEG) or oral sulfate solution (OSS) using overnight split-dosing. Pooling increased subgroup sample sizes. The primary endpoint was the bowel cleansing success, assessed by treatment-blinded central readers using the Harefield Cleansing Scale (HCS). Patients with no primary efficacy data were imputed as failures; the resulting estimates of efficacy were therefore conservative. Overall cleansing success and the mean number of high-quality cleansed segments per patient were calculated per reason for colonoscopy.

Results A total of 1103 patients were included. The pooled PLENVU arm (N=551) achieved a numerically higher overall cleansing success than the pooled 2LPEG/OSS arm (N=552) (88.6% vs 86.2%; P=0.328)([Table]). Overall cleansing success rates were consistently high for PLENVU across reasons for colonoscopy (range 86.7%-89.7%) and numerically higher for pooled PLENVU versus comparator: screening (89.1% vs 86.2%; P=NA), surveillance (86.7% vs 85.5%; P=0.3513) or diagnostic (89.7% vs 87.4%; P=0.4095). The mean number of high-quality cleansed segments per patient was significantly greater with PLENVU than 2LPEG/OSS in all performed comparisons (P< 0.009).

Tab. 1 Overall success rates and high-quality segments per patient in all patients and by reason for colonoscopy

	All patients	Screening	Surveillance	Diagnostic
Overall cleansing success rate (Pooled PLENVU vs 2LPEG/OSS), % (n/N)	88.6% (488/551) vs 86.2% (476/552)	89.1% (271/304) vs 86.2% (262/304)	86.7% (130/150) vs 85.5% (124/145)	89.7% (87/97) vs 87.4% (90/103)
1-sided P-value	0.328	NA	0.3513	0.4095
High-quality cleansed segments per patient (Pooled PLENVU vs 2LPEG/OSS), mean ± SD	2.3 ± 1.8 vs 1.8 ± 1.8	2.2 ± 1.8 vs 1.8 ± 1.8	2.3 ± 2.0 vs 1.7 ± 1.8	2.5 ± 1.8 vs 1.8 ± 1.8
1-sided P-value	<0.0001	0.0002	0.0089	0.0016

Conclusions PLENVU was highly effective across reasons for colonoscopy. It achieved overall cleansing success rates of similar high magnitude to the overall population and comparable to those achieved by 2LPEG/OSS. Greater high-quality cleansed segments with PLENVU is consistent with previous trial-specific assessments.