Date: 2017-02-02
Type of information: Interim results
phase: 1-2
Announcement: interim results
Company: Targovax (Norway)
Product: TG01
Action
mechanism: peptide/immunotherapy product. TG01 is a therapeutic cancer vaccine. This peptide vaccine targets mutations in the ras genes that are associated with cancer. Ras mutations disrupt normal cell division signaling and contribute to development of cancer cells and tumors. They are found in approximately 25% of all cancers and in particular in pancreatic cancer (80-90%), colorectal cancer (40%) and non-small cell lung cancers (30%).
Following intradermal administration, the vaccine peptides are taken up by antigen presenting cells that migrate to the lymph nodes and present the peptides to T cells. Subsequently the T cells get activated and enter the body's circulation with a potential to kill, or to stimulate the killing of, cancer cells.
Disease: resected pancreatic cancer
Therapeutic area: Cancer - Oncology
Country: Norway, Spain, UK
Trial
details: The purpose of this study is to investigate the effect of TG01 and Granulocyte macrophage colony stimulating factor (GM-CSF) when given in addition to gemcitabine (chemotherapy) and - Understand any possible side effects of the additional use of TG01/GM-CSF with gemcitabine - Investigate whether TG01/GM-CSF when given with gemcitabine can produce an immune response - Investigate if the treatment can delay or reduce recurrence of the disease. (NCT02261714)
Latest
news: * On February 2, 2017, Targovax announces encouraging overall survival data from an analysis of the first cohort of patients in its ongoing, phase I/II clinical trial evaluating TG01 (co-administered with GM-CSF in resected pancreatic cancer given in combination with chemotherapy, gemcitabine, the current standard of care, study CTTG01-01. A first cohort of 19 patients each received 36 injections of TG01/GMCSF synchronised with six cycles of gemcitabine and have now completed the study. Data from this patient cohort showed that 68% of evaluated patients (13/19) were still alive after two years if survival is counted from time of resection which occurred on average two months prior to first treatment, or 12/19 if counted from time of first treatment. While the cohort is small and there is no control arm, this rate compares favorably with the available published historical two-year survival rates of resected cancer patients treated with gemcitabine alone of between 30% and 53% (J Neoptolemos 2010, J van Loethem 2010, H Oettle 2013, M Sinn 2015, K Uesaka 2016; In these reported studies Overall Survival measured either from surgery or treatment randomization). Targovax has submitted an abstract to the ASCO annual meeting in June when the company plans to present the full data. * On June 7, 2016, Targovax announced that the open label Phase I/ II clinical trial of TG01 in combination with gemcitabine of patients with resected pancreatic cancer is fully recruited. A total of 32 patients have been included in the trial, with 13 patients in the modified cohort. The trial is an open label, phase I/II study of TG01/GM-CSF in combination with gemcitabine as adjuvant therapy for treating patients with resected adenocarcinoma of the pancreas. In the second cohort, the patients have received a modified vaccination regiment. Patients will be monitored for the next 24 months and final results, including two-year survival data in both cohorts, are expected in 1H 2017 and 1H 2018 respectively. In April 2016, Targovax announced preliminary immune activation data from this second cohort, which showed that a modified vaccination schedule also induced an immune response at week 8, after the induction phase. In March 2015, Targovax announced the immune results from the first cohort of the trial, indicating that 18 out of 19 patients were eligible for immune response assessment and 15 patients had established a detectable immune response.
