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Poster display session

1703 - An observational clinical study with RAS peptide vaccine TG01 evaluating immune response, safety and overall survival in patients with non-resectable pancreatic cancer


10 Sep 2017


Poster display session


Clinical Research;  Cancers in Adolescents and Young Adults (AYA);  Immunotherapy;  Pancreatic Cancer


Jon Amund Eriksen


Annals of Oncology (2017) 28 (suppl_5): v403-v427. 10.1093/annonc/mdx376


J.A. Eriksen1, I.P. Gladhaug2, A. Rosseland3, K. Risberg Handeland4, T. Buanes2

Author affiliations

  • 1 Technology Innovation, Targovax ASA, NO-0283 - Oslo/NO
  • 2 Department Of Hepato-pancreato-biliary Surgery, Oslo University Hospital, Oslo/NO
  • 3 Surgical Department, Central Hopital of Akershus, Lillestrøm/NO
  • 4 Clinical Department, Targovax ASA, NO-0283 - Oslo/NO


Abstract 1703


The study evaluated the immune response, safety and survival of the TG01/GM-CSF vaccine, an antigen-specific cancer immunotherapy consisting of 7 RAS peptides targeted to KRAS mutated pancreatic adenocarcinoma, in treatment naive non-resectable pancreatic cancer patients (pts). TG01/GM-CSF was recently reported to elicit immune response and increased survival in resectable pancreatic pts (ASCO 2017).


25 treatment naive non-resectable pancreatic cancer pts were immunised with TG01/GM-CSF at week 1, 2, 3, 4, 6, 10 (immunisation period) followed, after a 3 months pause, by a booster period of four weekly administrations. Pts were followed up for up to 12 months from 1st dose of TG01/GM-CSF. Immune response was evaluated by Delayed Type Hypersensitivity (DTH) skin reaction test, (S)AEs recorded throughout the study and survival data calculated using Kaplan-Meier.


14/25 pts (56%) had a positive DTH by week 10. The TG01/GM-CSF treatment was well tolerated with no reports of allergic or other adverse hypersensitivity reactions. 13 pts experienced 19 SAEs; 5 were due to disease progression, 13 were deaths due to disease progression, and one was treatment related (hypoglycaemia). Median survival (MS) from first administration of TG01/GM-CSF was for all treated pts (n = 25) 4.5 months, for DTH responders (n = 14) 5.1 months and for DTH non-responders (n = 11) 3.6 months. For the DTH responders the result compares favorably with untreated patients (MS ≈ 3.7 months)1. At 1 year, 4 pts of whom three DTH responders were alive. 1. Palmer KR et al., Br J Surg: 81, 882-885 (1994).


In pts treated with TG01/GM-CSF monotherapy, immune response was recorded in 56% of the pts, results that correspond with data from a Phase I/II trial with a similar RAS peptide vaccine in non-resectable pancreatic pts2. Even though not statistically significant, the results indicate increased survival for the immune responders. In the otherwise incurable disease, the non-resectable pancreatic pts may therefore benefit from immunisation with TG01/GM-CSF RAS peptide vaccine with few side effects. 2. Gjertsen M et al., Int J Can: 92, 441-450 (2001).

Clinical trial identification

Protocol CTN RAS 98010, 20.05.1998, Norway

Legal entity responsible for the study

Norsk Hydro ASA, Oslo, Norway


Norsk Hydro ASA, Oslo, Norway


J.A. Eriksen: Employed as chief technology innovation officer of Targovax ASA and hold stocks and options in the company. K. Risberg Handeland: Employee of Targovax ASA. All other authors have declared no conflicts of interest.

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