Targovax has conducted a predetermined interim analysis of the TG01 Phase I/II trial, indicating promising 1-year overall survival data when combining TG01 with gemcitabine (chemotherapy) as supplementary treatment of patients with pancreatic cancer.
Of the 19 patients included in the study, 15 patients provided consent to be followed up for survival and four patients did not provide consent to be followed up. 1-year survival data showed that 14 out of these 15 patient were alive and one passed away due to pneumonia assessed by the investigator as unrelated to the patients underlying cancer.
The regimen was generally well tolerated and RAS specific T-cell immune responses were induced and enhanced when TG01/GM-CSF was administered in combination with gemcitabine (1).
“One must be careful when drawing conclusions from small survival trials, but this result is an encouraging signal of efficacy and we look forward to the two year survival data which is expected during the first half year of next year”, says Gunnar Gårdemyr, CEO of Targovax.
The study is a single arm study of TG01 in combination with standard of care gemcitabine as adjuvant treatment of patients with operable pancreatic cancer. The interim analysis covered 1-year survival of the first cohort of 19 patients.
References: 1-year overall survival in two independent studies of patients with resected adenocarcinoma of the pancreas receiving standard of care gemcitabine were both approximately 75% (2,3)