Oslo, Norway, 23 May 2019 – Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, today announces median overall survival of 33.3 months and 38% three-year survival rate in the 32-patient phase I/II clinical trial evaluating TG01 in resected pancreatic cancer in combination with standard of care chemotherapy (gemcitabine).
Targovax has previously reported median overall survival (mOS) of 33.1 months for the 19 patients in the first dosing cohort, as well as 72% two-year survival rate and 94% mutant RAS-specific immune activation for the 32 patients enrolled in the trial. All patients are now past the three-year time point, showing mOS of 33.3 months and three-year survival rate of 38%. The mOS compares favorably to the ESPAC4 historical control trial of gemcitabine monotherapy, which reported mOS from surgery of 27.6 months.
Overall, the TG01 survival data are strengthened by the longer follow-up period and indicate a six-month improvement in survival over gemcitabine monotherapy in the ESPAC4 trial. In addition, the survival rates in the two patient cohorts are similar, which suggests that the reduced dosing regimen in the second cohort is as effective as for the first cohort where patients received more vaccinations.
Professor Daniel H. Palmer, University of Liverpool Cancer Research UK Experimental Cancer Medicine Centre, Liverpool, United Kingdom and lead investigator of the study, commented:
“Pancreatic cancer is a highly malignant, difficult to treat disease and there is a significant need for innovative new treatment approaches. The survival data from the TG01 trial in resected pancreatic cancer continue to look encouraging and are now more robust with the increased patient numbers and more mature follow-up.”
Magnus Jäderberg, Chief Medical Officer of Targovax added: “We are pleased to see strengthened signals of efficacy emerging for TG01. This three-year survival sweep finalizes the data collection and the trial is now considered completed. The complete data will be presented and published later this year.”
For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47 922 61 624
Media and IR enquires:
Andreas Tinglum – Corporate Communications (Norway)
Phone: +47 9300 1773
Activating the patient’s immune system to fight cancer
Targovax (OSE:TRVX) is a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors. Immuno-oncology is currently one of the fastest growing therapeutic fields in medicine.
Targovax’s lead product candidate, ONCOS-102, is a genetically modified oncolytic adenovirus, which has been engineered to selectively infect and replicate in cancer cells. It activates the immune system to generate tumor-specific immune responses. In a phase I monotherapy trial, ONCOS-102 induced both local and systemic innate and adaptive immune activation, with associated clinical benefit. In an ongoing phase I trial, patients who have progressed on anti-PD1 checkpoint inhibitors and treated with ONCOS-102 in combination with Keytruda, demonstrated responses in three of nine patients (33% ORR) including one complete response. ONCOS-102’s lead indication is mesothelioma, where the virus is currently being tested in a randomized phase I/II trial expected to report around new year 2019-20.