(Seoul = Yonhap News) Reporter Gye Seung-hyun = Genexine[095700]Said that the human papillomavirus (HPV) DNA vaccine’GX-188E’ (NOV1702), which is being developed as a new drug for cervical cancer treatment, showed an effect in the interim results of phase 2 clinical trials in combination with the MSD immune anticancer drug’Kitruda’ (ingredient name pembrolizumab). It was revealed on the 7th.
Genexine’s GX-188E is an immunotherapy vaccine that induces T-cell immune responses specific to HPV types 16 and 18.
In this clinical trial, 26 patients with terminal recurrent and progressive cervical cancer infected with HPV type 16 or 18 were administered GX-188E and Kitruda in combination.
Of these, 4 patients had complete remission (CR) in which all tumors disappeared, and 7 patients had partial remission (PR), which decreased the size of the cancer by more than 30%.
The objective response rate (ORR) of the combined use of GX-188E and Kitruda was 42.3%.
In addition, in a single-administered clinical trial with Kitruda, only patients with positive’PD-L1′, an immuno-anticancer biomarker (biomarker), responded, but in this combined clinical trial, patients with PD-L1 negative also responded.
In addition, the incidence of adverse reactions was similar to that of Kitruda alone, confirming the safety of the combination of DNA vaccine and immunotherapy. Interim clinical results were published in the international academic journal’The Lancet Oncology’.