The company has presented one-year data on survival rate, immune activation and safety in the modified cohort of the TG01 trial in resected pancreatic cancer patients.
The trial is an open label, phase I/II trial of TG01/GM-CSF in combination with gemcitabine as adjuvant therapy for treating patients with resected adenocarcinoma of the pancreas. The trial consists of two cohorts: the main cohort of 19 patients and a second, modified cohort of 13 patients. The purpose of the modified cohort is to build on the positive findings from the main cohort in order to further optimize the TG01 treatment regimen and safety profile of the combination therapy. Although manageable, some allergic reactions were seen in patients in the main cohort when treating with TG01 and gemcitabine in parallel. Hence, the modified cohort received fewer TG01 injections overall than the main cohort, administered non-concomitantly with gemcitabine.
The modified cohort started recruitment in 2015, and the last patient enrolled has now been in the trial for one year. The one-year survival rate and safety data in the modified cohort showed that:
- 100% of patients (13/13) were alive one year after surgery
- TG01/GM-CSF generated an immune response in 85% of patients (11/13)
- No serious adverse events related to allergic reactions have been 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. This further strengthens the safety profile of TG01, and adds valuable understanding that will help us optimize the dosing regimen in resected pancreatic cancer patients, a condition which is notoriously difficult to treat. We look forward to see the two-year survival data for the modified cohort next year,” said Magnus Jäderberg MD, Chief Medical Officer of Targovax.