Durability of response to VGX-3100 treatment of HPV16/18 positive cervical HSIL

Figures & data

Figure 1. Long-term follow-up populations

Abbreviations: HSIL, high-grade squamous intraepithelial lesion; LEEP, loop electrosurgical excision procedure.

Table 1. Viral clearance outcomes at 18 months following VGX-3100 or placebo

	VGX-3100	Placebo
	Avoided LEEP/CKC	Received LEEP/CKC
	No HSIL at Week 36 (n = 35) % (n)	HSIL Spontaneous Regression at Week 36 (n = 5) % (n)	HSIL at Week 36 (n = 25) % (n)
HPV 16/18 status 18 months after treatment completion
Cleared	91 (32)	100 (5)	88 (22)
Not cleared	9 (3)	0 (0)	12 (3)

HPV 16/18, HPV-16, and/or HPV-18.

Categories of ‘Avoided LEEP/CKC’ or ‘Received LEEP/CKC’ refer to the current study only, and are based on whether a subject had the procedure prior to that visit while on study, starting at D 0. Once a subject had an excision (i.e. LEEP or CKC), they are included in this column for all subsequent visits. Virologic clearance is defined as undetectable HPV Type 16/18 (i.e. elimination of the specific genotypes [16, 18 or both] present at screening). Subjects with a positive HPV test and no HPV types listed are considered not evaluable at that visit and excluded from the number of subjects tested. Percentages are based on the number of subjects who were tested at that scheduled visit.

Table 2. Pap smear results at 18 months post-treatment completion with VGX-3100 or placebo

		VGX-3100	Placebo
		Avoided LEEP/CKC	Received LEEP/CKC
		No HSIL at Week 36 (n = 32) % (n)	HSIL Spontaneous Regression at Week 36 (n = 5) % (n)	HSIL at Week 36 (n = 22) % (n)
18 months
	Worsening	0 (0)	20 (1)	0 (0)
	Improved	100 (32)	80 (4)	100 (22)
	No Change	0 (0)	0 (0)	0 (0)

Categories of ‘Avoided LEEP/CKC’ or ‘Received LEEP/CKC’ refer to the current study only, and are based on whether a subject had the procedure prior to that visit while on study, starting at D 0. Once a subject had an excision (i.e. LEEP or CKC), they are included in this column for all subsequent visits. Categorization of Pap smear changes was based on initial diagnosis of CIN2 or CIN3 corresponding to HSIL: worsening = Atypical glandular cells not otherwise specified; improved = LSIL, ASCUS, negative for lesion or malignancy, benign appearing endometrial or glandular cells (including endometrial cells in a woman at least 40 y of age), reactive endocervical and/or metaplastic cells, cellular changes (including reactive cellular changes associated with repair or radiation), and hyperkeratosis; no change = HSIL, ASC-H. Percentages are based on the number of evaluable subjects at that scheduled visit

Figure 2. HPV16/18 E6/E7 IFN-gamma ELISpot results (SFU/10⁶ PBMC) for follow-up groups by visit

Symbols represent medians and bars represent the interquartile range. Abbreviations: HPV, human papillomavirus; IFN, interferon; ELISpot, enzyme-linked immunospot; LEEP, loop electrosurgical excision procedure; PBMC, peripheral blood mononuclear cells; SD, standard deviation; SFU, spot forming units.