FDA Approves Tumor Treating Fields For Locally Advanced Disease

It’s a win for pancreatic cancer patients.

A tumor treating fields (TTFields or TTF) wearable device dubbed Optune Pax, developed by Novocure, received the go-ahead from the FDA for the treatment of locally advanced pancreatic cancer. The device will be used along with gemcitabine/nab-paclitaxel chemotherapy. This is the first new treatment approved for this stage of the disease in about three decades. TTFields was previously FDA-approved for adults with recurrent glioblastoma in 2011 and newly diagnosed glioblastoma in 2015.

Vincent Picozzi, M.D., an investigator on the completed PANOVA-3 trial on which the approval was based, was “very impressed by the outcomes of the first patients I treated with TTFields.” Picozzi is the director of the Pancreaticobiliary Program at Virginia Mason Franciscan Health, Seattle, Washington. The PANOVA-3 trial found that TTFields along with gemcitabine/nab-paclitaxel improved overall survival and mitigated pain. “Given the incurable nature (generally) of locally advanced pancreatic cancer, demonstrated improvement in quality of life is extremely important in addition to quantity of life,” says Picozzi.

A Win For Patients

Let’s Win has covered TTFields in depth. But here is a quick recap of the device and the PANOVA-3 trial.

• TTFields delivers alternating electric fields to malignant tumors, disrupting cell division and eventually causing cell death. It has no effect on healthy cells. Investigators discovered that TTFields also disrupts cell migration, activates the immune system thus generating an immune response, and slows down cancer cell division. It also mitigates pain.
• The phase III study included 571 patients with newly diagnosed, locally advanced disease. Patients were randomly assigned to receive TTFields plus the standard-of-care chemotherapy combo of gemcitabine/nab-paclitaxel or the chemotherapy combo alone. Study participants wore the device for a minimum of 18 hours per day.
• The median overall survival was 16.2 months in the TTFields plus chemotherapy group compared with 14.2 months in the chemotherapy alone group.
• In the participants who completed the trial and strictly adhered to the protocol (the per-protocol population), the median overall survival was 18.3 months for those in the TTFields arm, compared with 15.1 months in the chemotherapy-only arm. This included patients who received at least 28 days of TTFields therapy or one full cycle of chemotherapy.
• Nearly 70 percent of patients in the TTFields cohort were alive at one year compared to 60.2 percent receiving chemotherapy alone. In the per-protocol population, one-year survival was 75.2 percent and 65.9 percent, again favoring the TTFields group.
• Progression of pain was also delayed. The median time to pain progression was 15.2 months in the TTFields plus chemotherapy cohort versus 9.1 months in the chemotherapy-alone group. 

Novocure is also in the process of developing a “buddy” program for pancreatic cancer patients with locally advanced disease, similar to its successful program for patients with glioblastoma. This free, phone call-based “buddy” program, which is not available to those in clinical trials, connects patients with real-life users and caregivers who share their own experiences with the device, provide support and encouragement, as well as help navigate any potential challenges.

A New Modality for Oncologists

The data along with the subsequent FDA approval made a believer out of some skeptics. “When I first heard about using electricity I thought it was just hocus pocus,” says physician–scientist Conan Kinsey, M.D., Ph.D., of the Huntsman Cancer Institute in Salt Lake City, Utah, who was not involved in the study. “Although I’d like to see more confirmatory studies, I can’t argue with the data, which looks pretty good.”

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Improvement in overall survival plus improvement in progression of pain “are two winners for our patients,” he adds. “We all know that pancreatic cancer is very difficult to treat so this kind of advance is really important.” Kinsey plans on talking to his gastrointestinal oncology group to explore the feasibility of bringing TTFields on board for pancreatic cancer patients with locally advanced disease. “For years, these patients needed more options, and now they have one,” he notes. “I look forward to more studies on this.”

Indeed, TTFields provides a foundation for a number of clinical directions in pancreatic cancer, says Picozzi. For example, a study called PANOVA-4 is testing the device in patients with metastatic cancer. This pilot, single-arm study is using TTFields along with the immunotherapy drug atezolizumab plus standard-of-care gemcitabine/nab-paclitaxel as a first-line treatment for metastatic pancreatic cancer. The study has completed enrollment and study results are expected in early 2026.