A phase III randomized trial of chemoimmunotherapy comprising gemcitabine and capecitabine with or without telomerase vaccine GV1001 in patients with locally advanced or metastatic pancreatic cancer.

Gastrointestinal (Noncolorectal) Cancer
Session Type and Session Title: 
Oral Abstract Session, Gastrointestinal (Noncolorectal) Cancer
Abstract Number: 
J Clin Oncol 31, 2013 (suppl; abstr LBA4004)
Gary William Middleton, Juan W. Valle, Jonathan Wadsley, David Propper, Fareeda Y. Coxon, Paul J. Ross, Srinivasan Madhusudan, Tom Roques, David Cunningham, Philippa Corrie, William Greenhalf, Victoria Shaw, Trevor F. Cox, Paul Silcocks, Gemma Nanson, John P. Neoptolemos; University of Birmingham, Birmingham, United Kingdom; The Christie Hospital NHS Foundation Trust; European (ENETS) Centre of Excellence, Manchester, United Kingdom; Department of Clinical Oncology, Weston Park Hospital, Sheffield, United Kingdom; Institute of Cancer, Centre for Medical Oncology, St Bartholomew's Hospital, London, United Kingdom; Northern Centre for Cancer Care, Newcastle Upon Tyne, United Kingdom; Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom; School of Molecular Medical Sciences, Nottingham University Hospitals, Nottingham, United Kingdom; Norfolk and Norwich University Hospital, Norwich, United Kingdom; The Royal Marsden Hospital NHS Foundation Trust, London, United Kingdom; Oncology Centre, Addenbrooke's Hospital, Cambridge, United Kingdom; University of Liverpool, Liverpool, United Kingdom

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Abstract Disclosures


Background: GV1001, a promiscuous class II epitope encompassing aa 611-626 of hTERT led to the development of CD4+ clones recognizing hTERT in patients with advanced pancreatic cancer (APC). Preclinically gemcitabine increases antigen cross-presentation, enhances T cell trafficking/activation, and reduces MDSCs and Tregs. Methods: Patients with APC were randomized 1:1:1 to: Arm 1 GemCap; 2 GemCap for 8/52 followed by GV1001 followed by further GemCap if no PD at week 8; 3 concurrent administration of GemCap and GV1001. 735 (69.2%) had metastatic disease and 948 (89.3%) had ECOG PS=0 or 1. Randomization was stratified by stage and PS. Primary endpoint was overall survival (OS); secondary endpoints included ORR, TTP, and AEs. Recruitment target was 1,110 patients (780 deaths) to permit detection of a hazard ratio of 0.748 between either GV1001 arm and Arm 1 using a 2-sided α=0.025 level of significance with at least 80% power. Results: 1,062 pts from 51 centers were randomized. Trial maturity was high (72.7% patients died): median follow-up was 6.11 months. The overall response rates were Arm 1=17.6%; Arm 2=8.9% (p=0.001); Arm 3: 15.5% (p=0.460 compared with Arm 1). Conclusions: OS with concurrent GemCap/GV1001 was not different to that with GemCap alone. OS with sequential GV1001 was not statistically different to GemCap alone as it did not meet the criterion for statistical significance (p<0.0175). The addition of a T helper epitope vaccine to GemCap did not improve outcome compared to GemCap alone. Clinical trial information: 43482138.

Results for primary outcome.
Treatment No. of
patients (N)
No. of deaths
(% of N)
Median survival
in months
(95% CI)
survival rate
Hazard ratio*
(98.25% CI)
Log-rank test,
p value*
Arm 1 358 245 (68%) 7.89 33.7% 1 N/A
Arm 2 350 268 (77%) (7.07 to 8.85) (28.2 to 39.2) 1.19 0.0466
Arm 3 354 259 (73%) 6.94 25.3% (0.97 to 1.48) 0.6378
(6.35 to 7.60) (20.4 to 30.6) 1.05
8.36 32.3% (0.85 to 1.29)
(7.30 to 9.74) (26.9 to 37.8)
Total 1,062 772 (73%) - - N/A N/A

* ITT analysis using Cox regression and log-rank test stratified on ECOG and stage at randomization. Confidence level reflects the O’Brien-Fleming boundary and has the force of a 95% interval.