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Poster display session

4902 - PANOVA: A phase II study of TTFields (150 kHz) with concomitant standard chemotherapy for front-line advanced pancreatic adenocarcinoma – Updated efficacy results

Date

09 Sep 2017

Session

Poster display session

Presenters

Marc Kueng

Citation

Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369

Authors

M. Kueng1, C. Guillen-Ponce2, F. Rivera Herrero3, J. Gallego Plazas4, J.A. Lopez-Martin5, M. Benavides6

Author affiliations

  • 1 Oncology-haematology, HFR Fribourg - Hopital Cantonal, 1700 - Fribourg/CH
  • 2 Medical Oncology, Hospital Universitario Ramon y Cajal, 28031 - Madrid/ES
  • 3 Medical Oncology, Hospital Universitario Marques de Valdecilla, 39008 - Santander/ES
  • 4 Medical Oncology, Hospital General Universitario de Elche, 3203 - Elche/ES
  • 5 Oncology, Hospital Universitario 12 de Octubre, 28041 - Madrid/ES
  • 6 Medical Oncology, Hospital Universitario Regional y Virgen de la Victoria, 29010 - Malaga/ES
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Resources

Abstract 4902

Background

TTFields are a non-invasive, regional antimitotic treatment modality approved for the treatment of glioblastoma. TTFields act by disrupting mitotic spindle formation during metaphase. TTFields were effective in preclinical models of pancreatic cancer. PANOVA was the first trial testing TTFields in pancreatic cancer. Results from the first arm of the study, testing TTFields in combination with gemcitabine, have demonstrated superiority in efficacy versus historical controls (J Clin Oncol 34, 2016 (suppl 4S; abstr 269).

Methods

Twenty advanced pancreatic cancer patients were enrolled in the second arm of PANOVA and treated with TTFields in combination with gemcitabine concomitant to nab-paclitaxel. All patients had unresectable tumors, ECOG score of 0-1 and no prior therapy. The primary endpoint was the incidence and severity of adverse events.

Results

The median age was 68.2 (range – 58-81) and most patients (65%) had an ECOG score of 1. Twelve patients (60%) had distant metastases. Ten patients (50%) had serious AEs during the study period. Eleven patients (55%) had treatment-related skin toxicity, of which 5 had grade 3 toxicity. No TTFields-related serious AEs were reported. The median PFS was 12.7 months (95% CI 5.4, NA): 9.3 months in patients with metastatic disease, and not reached in locally-advanced patients. PFS rate at 6 months was 65%: 50% in metastatic disease and 87.5% in locally advanced patients. Of the evaluable tumors, 40% had partial response and another 47% stable disease. The median OS was not reached, and the 1-year survival rate was 72% (62.5% in metastatic disease and 87.5% in locally advanced disease). None of the patients who had a minimal average compliance of 75% died during the follow up period. 87% of the evaluable patients (including all metastatic patients) had a decrease in CA-19-9 levels.

Conclusions

TTFields concomitant to gemcitabine and nab-paclitaxel are safe for advanced pancreatic cancer patients, with promising clinical outcome which doubled historical data. A phase III trial is planned, testing the efficacy of TTFields combined with gemcitabine and nab-paclitaxel in locally-advanced pancreatic cancer patients.

Clinical trial identification

NCT01971281

Legal entity responsible for the study

Novocure

Funding

Novocure

Disclosure

C. Guillen-Ponce: Advisor/board member: Merck Serono, Roche Pharma, Bayer, Sanofi Aventis, Celgene, Novocure. - Speaker’s bureau: Celgene, Merck Serono, Roche Pharma. - Travel and accommodation: Celgene, Roche Pharma, Sanofi Aventis, Merck Serono. F. Rivera Herrero: Grants/research: Celgene, Amgen. Merck-Serono, MSD, Lilly, Roche, Sanofi, Bayer, Advisor/board member: Celgene, Amgen. Merck-Serono, Lilly, Roche, Sanofi, Bayer, Servier, Baxalta Consultant/independent contractor: Celgene, Amgen. J. Gallego Plazas: Advisor/board member: Amgen, Lilly, Roche, Merck. Honorarium: Amgen, Lilly, Roche, Merck. All other authors have declared no conflicts of interest.

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