Phase III REVEAL 1 trial of VGX 3100 meets endpoint in HPV-16/18-associated cervical squamous intraepithelial lesions.- Inovio

Inovio announced it met primary and secondary endpoints among all evaluable subjects for the REVEAL 1 trial, one of two ongoing pivotal, randomized, double-blind, multi-center, placebo-controlled, Phase III trials (REVEAL 1 and REVEAL 2) evaluating the safety, tolerability and efficacy of VGX 3100 to treat HPV-16/18-associated cervical high-grade squamous intraepithelial lesions (HSIL) using the company's proprietary CELLECTRA 5PSP device. For the primary endpoint of histopathological regression of HSIL combined with virologic clearance of HPV-16 and/or HPV-18 at week 36, the percentage of responders was 23.7% (31/131) in the treatment group, versus 11.3% (7/62) in the placebo group (p=0.022; 12.4% difference in percentage, 95%CI: 0.4,22.5), thus achieving statistical significance. All secondary efficacy endpoints were achieved. These endpoints were: a) regression of cervical HSIL to normal tissue combined with HPV-16/18 viral clearance, b) regression of cervical HSIL alone, c) regression of cervical HSIL to normal tissue, and d) HPV-16/18 viral clearance alone. Including subjects with missing endpoint data, the percentage of subjects meeting the primary endpoint was 22.5% (31/138) in the treatment group, versus 11.1% (7/63) in the placebo group (p=0.029; 11.4% difference in percentage, 95%CI: -0.4,21.2), which was not statistically significant. All secondary endpoints were achieved except for regression of cervical HSIL alone (12.8% difference in percentage, 95%CI: -0.6,24.5). There were no treatment-related serious adverse events and most adverse events were self-resolving and were considered to be mild to moderate, consistent with earlier clinical trials.