2016 GI Symposium: Tumor-Treating Fields Plus Chemotherapy May Be Safe as First-Line Treatment in Advanced Pancreatic Cancer
Novocure presented data from its ongoing phase II PANOVA clinical trial at the 2016 Gastrointestinal Cancers Symposium in San Francisco, showing that tumor-treating fields therapy plus first-line gemcitabine is tolerable and safe in patients with advanced pancreatic cancer. The data also suggest improved survival and response rate among patients who received tumor-treating fields therapy with gemcitabine compared to a historical control of patients who received gemcitabine alone. These findings were presented by Rivera et al (Abstract 269).
Key Findings
The first cohort of the prospective, single-arm study included 20 patients with advanced pancreatic cancer whose tumors could not be removed surgically and who had not received chemotherapy or radiation therapy prior to the clinical trial. The primary endpoint measured the incidence and severity of treatment-related adverse events.
As a result of tumor-treating fields therapy, 10 patients experienced treatable contact dermatitis. No serious adverse events related to tumor-treating fields were reported. Fourteen patients reported serious adverse events unrelated to tumor-treating fields therapy.
A phase III study of the efficacy and safety of nab-paclitaxel (Abraxane) plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer published in October 2013 in The New England Journal of Medicine by Von Hoff et al showed that patients who received gemcitabine alone experienced a median progression-free survival of 3.7 months, a median overall survival of 6.7 months, a median 1-year survival of 22%, and a response rate of 7%.
In relation to these reported results for gemcitabine alone, PANOVA patients who received tumor-treating fields therapy plus first-line gemcitabine experienced a median progression-free survival of 8.3 months compared to 3.7 months, a median overall survival of 14.9 months compared to 6.7 months, and a median 1-year survival of 55% compared to 22%. Thirty percent of the evaluable tumors had partial responses compared to 7% with gemcitabine alone, and another 30% had stable disease.
The PANOVA trial includes a second cohort testing tumor-treating fields plus gemcitabine and nab-paclitaxel in an additional 20 patients. Preclinical models have demonstrated increased cancer cell sensitivity when tumor-treating fields therapy is combined with taxane-based chemotherapies, such as nab-paclitaxel.
“The phase II results are promising,” said Fernando Rivera, MD, PhD, the study’s principal investigator and a Senior Medical Oncologist at the Santander University Hospital in Spain. “Given these first cohort results and the synergistic effect that was demonstrated in preclinical models when [tumor-treating fields] therapy was combined with taxane-based chemotherapies, I am even more optimistic about what the second cohort will show when nab-paclitaxel is added to the treatment regimen.”
“We are pleased by these results,” said Asaf Danziger, Novocure’s CEO. “Over the last 15 years, in all of our preclinical and clinical research we have observed that the physical, antimitotic effect of [tumor-treating fields] is consistent regardless of cancer type. Based on these data, we will accelerate planning of a phase III clinical trial in pancreatic cancer.”
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
