08:10 uur 20-03-2019

SOTIO’s DCVAC/OvCa verbetert de overleving van patiënten met terugkerende eierstokkanker significant

    • DCVAC/OvCa verminderde het risico op overlijden bij tweedelijnsbehandeling van eierstokkanker met 62%
    • Totale overleving (OS) nam significant toe, met 13,4 maanden. Mediane progressievrije overleving (mPFS) steeg met 1,8 maanden.
    • SOTIO is van plan een wereldwijd Fase III-onderzoek met DCVAC/OvCa te starten

HONOLULU & PRAAG–(BUSINESS WIRE)–SOTIO, een biotechnologiebedrijf dat eigendom is van de PPF Group, presenteerde vandaag op de 2019 SGO’s 50th Annual Meeting on Women’s Cancer de resultaten van SOV02. Dat is een fase II klinische studie ter evaluatie van DCVAC/OvCa, een actief cellulair immunotherapieproduct bij patiënten met recidiverende eierstokkanker. Uiteindelijke analyse van SOV02 toont dat DCVAC/OvCa het overlijdensrisico significant verlaagt in vergelijking met patiënten die geen DCVAC/OvCa kregen. Klinische proefresultaten werden gepresenteerd tijdens de SGO 2019 Plenaire Sessie van vandaag door SOV02 hoofdonderzoeker David Cibula, MD, PhD van General University Hospital in Praag (Tsjechische Republiek).

Dit persbericht bevat multimedia. Bekijk de volledige release hier: https://www.businesswire.com/news/home/20190319005837/en/

SOTIO’s DCVAC/OvCa Significantly Improves Survival in Patients with Recurrent Ovarian Cancer

    • DCVAC/OvCa decreased the risk of death in second line treatment of ovarian cancer by 62%
    • Overall survival (OS) increased significantly by 13.4 months. Median Progression Free Survival (mPFS) increased by 1.8 months.
    • SOTIO plans to initiate a global Phase III study with DCVAC/OvCa

HONOLULU & PRAGUE–(BUSINESS WIRE)– SOTIO, a biotechnology company owned by the PPF Group, presented results from SOV02, its Phase II clinical trial evaluating DCVAC/OvCa, an active cellular immunotherapy product, in patients with recurrent ovarian cancer at 2019 SGO’s 50th Annual Meeting on Women’s Cancer today. Final analysis of SOV02 shows that DCVAC/OvCa decreased the risk of death significantly compared to patients who did not receive DCVAC/OvCa. Clinical trial results were presented during today’s SGO 2019 Plenary Session by SOV02 principal investigator David Cibula, MD, PhD from General University Hospital in Prague (Czech Republic).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190319005837/en/

In the randomized, open label SOV02 clinical trial, patients with recurrent ovarian cancer received DCVAC/OvCa in combination with platinum-based chemotherapy. Compared to patients who did not receive DCVAC, it decreased the risk of death by 62%. The combination of chemotherapy and immunotherapy corresponded with 73% survival at two years, compared to 41% survival when chemotherapy was used alone. Overall survival results are statistically significant with a p-value of 0.0032. Progression Free Survival (PFS) increased from 9.5 to 11.3 months. Treatment with DCVAC/OvCa was very well tolerated and did not lead to any treatment discontinuation.

“Results from final data analysis of SOV02 clinical trial show that patients with recurrent ovarian cancer treated with DCVAC/OvCa are living significantly longer than patients in the control group. This outcome stands out very positively in this highly competitive clinical development landscape,” said David Cibula, MD, PhD, General University Hospital (Prague, Czech Republic), Past-President of European Society of Gynaecological Oncology (ESGO), principal investigator of SOV02 study.

Radek Spisek, MD, PhD, Chief Executive Officer of SOTIOcommented: “We are very happy that the results of SOV02 study in the second line treatment of ovarian cancer confirm the promising data of SOV01 trial in the first line, reported at ASCO 2018. In cooperation with ENGOT, we are now setting up the design of the pivotal trial that will build on the results of the Phase II program. With the development of DCVAC/OvCa and the latest result we are addressing the medical need in this harmful disease.”

More information and details about the SOV02 clinical trial results can be found in the slides from the oral presentation at SGO 2019 posted on SOTIO’s webpage.

About SOV02 clinical trial:
SOV02 is a randomized, open-label, parallel-group, multi-center Phase II clinical trial evaluating the effect of adding DCVAC/OvCa to standard chemotherapy (carboplatin and gemcitabine) in women with first relapse of platinum-sensitive epithelial ovarian cancer.

Contacts

Richard Kapsa
Head of Communication
T: (+420) 224 174 448
M: (+420) 603 280 971
kapsa@sotio.com

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