Genexine Inc., a clinical stage biotechnology company developing innovative biologics, announced that GX-188E in combination with KEYTRUDA® (pembrolizumab) Phase II cervical cancer trial is entering into Simon Stage 2, after achieving targeted response rate in Stage 1. This study was initiated in May 2018, targeting patients with HPV (Human Papilloma Virus)-induced recurrent, relapsed, and metastatic cervical cancer.

The study is being conducted in seven major hospitals in Korea, including Seoul St. Mary’s Hospital, Asan Medical Center, and the National Cancer Center. Genexine and Merck & Co., Inc., Kenilworth, N.J., USA.adopted the Simon two-stage design, which mandates to see a response rate from at least 3 patients in Stage 1 out of maximum 15 patients enrolled. The response is defined as either complete or partial remission of cancer, indicated by the reduction of tumor size by a specific percentage. Genexine and Merck & Co., Inc., Kenilworth, N.J., USA.agreed to enter the Stage 2 earlier than planned after evaluating responses from 10 patients instead of 15, as the target response rate in Stage 1 was met including one of the patients showing complete response (CR). The study design allows enrolling total 28 patients for the Stage 2.

Based on WHO statistics 2018, Cervical cancer, caused by Human papillomavirus infection (HPV), is the fourth most common cancer in women, and up to 50% of cervical cancer patients develop the recurrent disease or metastatic disease (Cochrane Database Syst Rev. 2012). In June 2018, Keytruda® (pembrolizumab) was approved by the U.S. Food and Drug Administration (FDA) under accelerated approval regulations for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] with 14.3% of objective response rate.