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

March 19, 2019 Off By BusinessWire

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 50^th 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).

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 SOTIO commented:
“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.