CONTACT US
A device already approved to treat several other types of cancer has shown positive results for a subset of patients with pancreatic cancer. In a Phase III clinical trial, a therapy known as Tumor Treating Fields (TTFields) increased survival for patients whose pancreatic cancer had not spread to other organs but cannot be removed by surgery, when used in combination with chemotherapy.
“We are encouraged to see these results from the PANOVA-3 trial and are grateful to the company Novocure for evaluating their TTFields in unresectable, locally advanced pancreatic adenocarcinoma, an especially hard-to-treat cancer type,” said PanCAN’s Chief Scientific and Medical Officer Anna Berkenblit, MD, MMSc. “We are also thankful for the patients and investigators who participated in this trial, and we look forward to reviewing the full data at an upcoming medical conference.”
This is the first positive study for this patient population and it demonstrates the impact of increased research efforts in pancreatic cancer and why PanCAN continues to advocate for more private and federal investment in the disease.
Next, Novocure will need to take their data to the U.S. Food and Drug Administration (FDA). If the FDA grants approval for TTFields in pancreatic cancer, it will be made available as a treatment for patients with unresectable, locally advanced pancreatic adenocarcinoma.
In this blog post, PanCAN addresses questions related to this news.
What was the news announced today? What are the key take-aways?
The oncology company Novocure announced positive results from a Phase III clinical trial called PANOVA-3. The trial enrolled patients with unresectable, locally advanced pancreatic adenocarcinoma. This means that for all participants, their cancer had not spread far beyond their pancreas, but had advanced to the point where it could not be surgically removed.
The 571 trial participants were randomly divided into two groups: One group received a therapy known as Tumor Treating Fields (TTFields) in combination with a standard of care chemotherapy regimen called gemcitabine and nab-paclitaxel. The second group received gemcitabine and nab-paclitaxel alone.
At the end of the trial, participants who received the TTFields survived an average of two months longer than patients who received only the chemotherapies.
Talk more about the results of this trial. What does this mean for patients?
The overall survival benefit of two months for patients treated with TTFields is statistically significant, which means that it was unlikely to have occurred by chance. Specifically, patients who were treated with TTFields in addition to chemotherapy lived an average of 16.20 months, whereas patients treated with chemotherapy alone lived an average of 14.16 months.
What is Tumor Treating Fields Therapy?
TTFields is a therapeutic option that has been approved by the FDA to treat glioblastoma, a type of tumor found in the brain and spinal cord, and metastatic non-small cell lung cancer. It is a portable, battery-operated device that uses electric fields called tumor treating fields to slow and reverse tumor growth by inhibiting mitosis (the process by which cells divide and replicate). TTFields do not significantly affect healthy cells because they have different properties than cancer cells.
What are the side effects?
According to information provided by the company, TTFields was well-tolerated and safety was consistent with prior clinical studies. The most common device related side effect reported is mild to moderate skin irritation beneath the arrays. When TTFields are delivered, the arrays may cause mild warming and tingling of the skin underneath them.
Why are the results of this trial important?
Pancreatic cancer is the only major cancer with a five-year survival rate still below 20%. We need new treatments and better options for patients facing this challenging diagnosis, especially for patients who aren’t able to have surgery. This therapy has advanced through clinical trials testing both safety and efficacy, which are important hurdles on the path to a new treatment becoming available. While it has not yet been approved for the group studied, the results are promising.
Research for other groups of patients with pancreatic cancer is ongoing. Novocure is also testing TTFields in combination with chemotherapy/immunotherapy in patients with metastatic pancreatic cancer, also called stage IV cancer. This is where cancer has spread to organs throughout the body.
I am a patient with pancreatic cancer interested in this treatment. What should I do?
The PANOVA-3 trial has closed and is no longer enrolling patients. Contact PanCAN Patient Services for information on active clinical trials and other treatment options and support. Our expert Case Managers can answer your questions and connect you with resources to learn more about pancreatic cancer treatments and more.
What does Novocure need to do next to move this treatment forward?
Following the positive clinical trial results from PANOVA-3, Novocure will request that the FDA add another indication to allow it to be used in patients with locally advanced, unresectable pancreatic cancer. If the FDA grants approval for TTFields in pancreatic cancer, it will be made available as a treatment for this group of patients.
