Targovax reports encouraging disease-free survival (DFS) data from TG01 trial in resected pancreatic cancer

16.1 months median DFS with TG01 and gemcitabine combination for all 32 patients in the trial

19.5 months DFS in 2nd cohort who received an optimized dosing regimen

94% of patients had mutant RAS specific adaptive immune activation

Oslo, Norway, 15 October 2018 - Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard to treat solid tumors, today announces the full data set from the 32-patient phase I/II clinical trial evaluating TG01 in resected pancreatic cancer in combination with standard of care chemotherapy (gemcitabine). Median DFS for all 32 patients in the trial was 16.1 months, and 19.5 months for the 2nd patient cohort who received an optimized dosing regimen. DFS was measured from time of surgery. This DFS outcome is encouraging when compared to historical controls for gemcitabine monotherapy, such as the ESPAC4 and PRODIGE trials, which reported a median DFS of around 13 months in similar patient populations.

The trial enrolled a total of 32 patients, split in two patient cohorts receiving different dosing regimens. The 1st cohort (n=19) received most TG01 injections before and during chemotherapy, whereas the 2nd cohort (n=13) received more injections after completing the chemotherapy regimen. This is believed to be a more optimal dosing schedule for therapeutic cancer vaccines such as TG01. In May 2018, encouraging two-year survival rate and median overall survival (mOS) was reported for the 2nd patient cohort, and for all 32 patients in the trial combined, see press release.

Summarizing the data from the trial published to date:

Full trial, 32 patients (both cohorts combined)

16.1 months median disease-free survival (mDFS)
33.4 months median overall survival (mOS)
72% of patients (23/32) were alive two years after surgery
94% of patients (30/32) demonstrated mutant RAS-specific immune activation

First cohort, 19 patients

13.9 months median disease-free survival (mDFS)
33.1 months median overall survival (mOS)
68% of patients (13/19) were alive two years after surgery

Second cohort, 13 patients

19.5 months median disease-free survival (mDFS)
Median overall survival not yet reached at time of analysis
77% of patients (10/13) were alive two years after surgery

The full phase I/II data set will be presented by the trial Principal Investigator, Professor Daniel Palmer from University of Liverpool in the UK, at the Targovax capital markets update in Oslo, October 15th at 8:30am CET. The presentation will also be available via webcast. Please see here for more information.

Dr. Magnus Jäderberg, CMO of Targovax, said: “We have previously reported strong immune activation and signal of efficacy for TG01 in resected pancreatic cancer. The median DFS data now presented further strengthens our confidence that TG01 provides a clinically meaningful benefit for this patient population, especially when in the context of historical controls. The DFS benefit appears to be more pronounced in the second cohort, which indicates that the post-chemo vaccination schedule is an optimal dosing regimen that we should select in subsequent development. It is also worth noting that median overall survival has not yet been reached in the second patient cohort, and we will continue to track how these patients perform with great interest”.

About the study

CTTG01-01 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 main objectives of the trail are an assessment of safety and immune activation. The secondary objective is to assess efficacy (disease-free survival and overall survival) at two years. The Company has received consent to enable the reporting of overall survival for all patients in the trial. The trial has been conducted in four centres in the UK and Norway.

The first cohort of 19 patients each received up to 36 injections of TG01/GM-CSF, before, during and after six cycles of gemcitabine. The second cohort consists of 13 patients, who received up to 15 injections of TG01/GM-CSF before and after, but not during, gemcitabine treatment. The second cohort received on average 7 injections after chemotherapy, compared to only one for the first cohort. Overall, the treatment is well tolerated in both dosing regimens. Although manageable, some allergic reactions were seen in patients in the first cohort when treating with TG01 and gemcitabine in parallel. No such allergic reactions were seen in the second cohort.

TG01 is Targovax’s lead product candidate from its mutRAS neoantigen cancer vaccine program. The product is an injectable peptide-based immunotherapy designed to treat patients with mutant RAS solid tumors. RAS mutations are the most frequently found oncogenic mutations in cancer overall, and are associated with poor prognosis. Published data suggests that more than 90% of pancreatic cancer patients have mutant RAS.