Targovax ASA’s cancer immunotherapy TG01 significantly prolonged 2-year overall survival of patients with resected pancreatic cancer versus standard therapy. Targovax’ shares were up 16% on Thursday evening.
Median overall survival was 33.4 months versus 27.6 months in the Phase I/II ESPAC4 trial. In 32 patients with resected pancreatic cancer the survival benefit of TG01 + chemotherapy was about 6 months vs standard chemotherapy. For a first 19 patient cohort, receiving TG01 injections, before, during and after adjuvant chemotherapy treatment, Targovax reported a survival rate 68% (13/19 patients) and median overall survival of 33.1 months in 2017. For the second cohort of 13 patients, who received a reduced dose of TG01 injections before and after, but not during, chemotherapy treatment, the two-year survival rate was even higher (77%, 10/13 patients) than in the first cohort as well as for diverse historical studies with gemcitabine monotherapy (30-53%). As of the end of May 2018, median overall survival in the second cohort was not yet reached.
While 94% of patients (30/32) were alive one year after surgery, 72% of patients (23/32) were alive two years after surgery. 90% of them (29/32) demonstrated mutant RAS-specific immune activation. The full data set, including immune monitoring, will be further analyzed and presented at a relevant scientific conference.
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 results from this study are promising and demonstrate that TG01 is generally well tolerated in combination with gemcitabine. We observe a high level of mutant RAS-specific immune activation, and the observed survival rate is encouraging compared with chemotherapy alone. It will now be important to assess the clinical efficacy of the TG01 and standard of care combination treatment in a randomized setting, and we look forward to take part in the development of this innovative immunotherapy going forward".
Øystein Soug, Chief Executive Officer of Targovax said : "The high rate of immune activation, combined with the encouraging survival data which compares well with the large ESPAC4 trial, further strengthens our belief that our mutant RAS neoantigen vaccine has potential to be a promising new treatment approach in combating mutant RAS tumors, which constitutes up to 30% of all cancers."
TG01 is Targovax's lead product candidate from its mutRAS neoantigen cancer vaccine program. The product is an injectable peptide-based immunotherapy designed to treat patients with mutant RAS solid tumors. RAS mutations are the most frequently found oncogenic mutations in cancer overall, and are associated with poor prognosis. Published data suggests that more than 90% of pancreatic cancer patients have mutant RAS.