1153P - An observational clinical study with RAS peptide vaccine TG01 evaluating immune response, safety and overall survival in patients with non-resectab...

Date 10 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Drug Development
Cancer in Adolescents
Cancer Immunology and Immunotherapy
Pancreatic Cancer
Presenter Jon Amund Eriksen
Citation Annals of Oncology (2017) 28 (suppl_5): v403-v427. 10.1093/annonc/mdx376
Authors J.A. Eriksen1, I.P. Gladhaug2, A. Rosseland3, K. Risberg Handeland4, T. Buanes2
  • 1Technology Innovation, Targovax ASA, NO-0283 - Oslo/NO
  • 2Department Of Hepato-pancreato-biliary Surgery, Oslo University Hospital, Oslo/NO
  • 3Surgical Department, Central Hopital of Akershus, Lillestrøm/NO
  • 4Clinical Department, Targovax ASA, NO-0283 - Oslo/NO

Abstract

Background

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).

Methods

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.

Results

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).

Conclusions

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

Funding

Norsk Hydro ASA, Oslo, Norway

Disclosure

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.