Targovax reports 100% one-year survival in pancreatic cancer trial
Norwegian Targovax ASA (Oslo) has reported tremendous safety, immunogenicity, and one-year survival data, of in the modified cohort of the TG01 trial in resected pancreatic cancer patients.
In the main cohort of the Phase I/II study of TG01/GM-CSF in combination with gemcitabine as adjuvant therapy for treating patients with resected adenocarcinoma of the pancreas, Targovax had reported an overall survival of 33.1 months in 19 patients. In the modified cohort of 13 patients, which was designed to build on the positive findings from the main cohort in order to further optimise the TG01 treatment regimen and safety profile of the combination therapy, Targovax now reported that 100% of patients (13/13) were alive one year after surgery. Furthermore, TG01/GM-CSF generated an immune response in 85% of patients (11/13), and no serious adverse events related to allergic reactions were reported.
"We are delighted that we maintain a strong immune response and one-year survival rate with the reduced dosing regimen, essentially equivalent to and consistent with the previously reported data from the main cohort, said Magnus Jäderberg MD, Chief Medical Officer of Targovax.
TG01 is an injectable antigen-specific cancer immunotherapy targeted to treat patients with KRAS mutations, found in more than 85% of pancreatic adenocarcinomas. TG01 consists of a mixture of 7 synthetic peptides that represent 7 of the most common codon 12 and 13 mutations in p21RAS associated with human cancer. TG01 induces RAS mutant-specific T-cell responses which are enhanced by co-administration of GM-CSF (recombinant human granulocyte macrophage-colony stimulating factor). TG01 was the first therapeutic peptide vaccine targeting RAS that entered clinical trials. Earlier studies demonstrate that adjuvant vaccination with TG01/GM-CSF given as monotherapy to pancreatic cancer patients after tumor resection induce immune response in 100% of patients.