538P Adding plasmid encoding p62/SQSTM1 to gemcitabine chemotherapy increases PFS for patients with platinum-resistant ovarian cancer (updated data)

Here we report the results of second interim analysis a randomized prospective multi-center clinical study aimed to evaluate safety and efficacy p62/SQTM1-encoding plasmid applied as an adjuvant chemotherapy in patients with advanced platinum-resistant ovarian cancer. P62 encoding acts classic anti-cancer DNA vaccine it also lowers chronic inflammation thus rendering tumor cells more susceptible immune response chemotherapy. A was started 2020. Chemotherapy (Gemcitabine 1000 mg/m2 days 1,8 every 3 weeks) administered both arms. In Chemo arm (n = 20) only treatment, Plasmid same chemo supplemented p62-plasmid (2.5 mg i.m. weekly). To data cut-off, median follow-up 11.1 months Efficacy-Evaluable Set. The progression-free survival (PFS) 2.7 6.6 mo arms respectively (p Log-Rank 0.018). Noteworthy, today, 35% group did not progress longest PFS recorded so far is 24 months. assessed according RECIST 1.1 criteria. No complete responses were observed either group. objective rate higher arm: partial (PR) - 5.0% 20.0%, stable disease (SD) 40.0% 60.0%, progression 55.0% control (PR SD) 45.0% 85.0% 0,001). One patient underwent cytoreduction no evidence progression. Grade 3-4 toxicities All adverse effects managed by conventional medications. treatment delays or interruptions due plasmid-related events registered. this show that adding p62/SQSTM1-encoding standard Gemcitabine for cancer novel approach which safe, well-tolerated effective: improves ORR, DCR, PFS. long-lasting some typical immunotherapeutic agents. ongoing.