Genexine, a Korean biopharmaceutical company, announced in August that its “first-in-class proprietary DNA vaccine” demonstrated efficacy and safety in a Phase II study. The study examined these two qualities of the vaccine in patients with advanced cervical cancer. The vaccine was administered in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy.
The Phase II treatment group involved 60 patients with HPV 16- and/or 18- positive advance cervical cancer who had progressed after standard-of-care therapy. It was an “open-label, single-arm” trial and took place in South Korea. Each patient received intramuscular doses at weeks 1, 2, 4, 7, 13, 19 and an optional dose at week 46. Additionally, they received intravenous pembrolizumab every 3 weeks for up to 2 years.
Genexine reported that top line results showed a Best Overall Response Rate (BORR) of 31.7%. This increased to 38.5% in PD-L1 positive patients with HPV 16+ and Squamous Cell Carcinoma. The statement highlighted that PD-L1 negative patients showed an ORR of 25%. This was “extremely encouraging for this patient population” as it “demonstrates potential improvement in efficacy” on monotherapy of immune checkpoint inhibitors. This suggests a “beneficial effect of the combination therapy”.
“The combination therapy was found to be safe and tolerable with a similar safety profile to that of pembrolizumab monotherapy.”
For Professor Sung-Jong Lee of the Catholic University of Korea, College of Medicine, and investigator in the trial, the data are “very encouraging”. Acknowledging the “urgent need for better therapies” the professor believes that this combination could be a “strong alternative”.
“I am particularly pleased to see a clear efficacy signal in all patients.”
Furthermore, the professor commented on the “mechanistic” appeal of this combination therapy. The approach “appears to result in a strong, beneficial effect”, made clear by the results of the trial. Neil Warma, President and CEO of Genexine, also offered his thoughts. He was “encouraged” by the study and hopes that this combination therapy could “represent a new standard of care for patients”.
“This could open the door to a new therapy for this patient population that previously had limited treatment options available”.