Dr Picozzi on the Significance of the PANOVA-3 Study for Future TTField Development in Pancreatic Cancer

“PANOVA-3, in which the TTFields were tested, is really the first positive trial ever in this stage of pancreatic cancer, so it's a historical landmark for that reason."

Vincent Picozzi, MD, medical oncologist and director for the Pancreaticobiliary Program at the Floyd & Delores Jones Cancer Institute at Virginia Mason Medical Center, discussed the clinical impact of the FDA approval of Optune Pax for concomitant use with gemcitabine and nab-paclitaxel (Abraxane) in adult patients with locally advanced pancreatic cancer.

This first-of-its-kind, portable, and noninvasive device delivers tumor treating fields (TTFields)—alternating electrical fields that specifically disrupt cancer cell division to minimize damage to surrounding healthy tissue. The approval was supported by data from the phase 3 PANOVA-3 study (NCT03377491). Findings from the trial demonstrated that patients treated with the combination of Optune Pax and chemotherapy experienced a statistically significant 2-month improvement in median overall survival (OS) compared with those receiving gemcitabine plus nab-paclitaxel alone (HR, 0.82; 95% CI 0.68-0.99; P = 0.039).

Picozzi characterized the PANOVA-3 trial as a historical landmark, noting it represents the first positive clinical trial ever recorded for this specific stage of pancreatic cancer. A particularly notable finding from PANOVA-3 was the improvement in systemic disease progression, meaning disease advancement was curtailed even outside the local tumor area. This suggests that TTFields may exert a systemic effect, possibly through an immunological mechanism, he explained.

Picozzi asserted that this study provides a vital foundation for further development of the device alongside other therapies, such as KRAS inhibitors, PARP inhibitors, and immunotherapy.

Looking ahead, the phase 2 PANOVA-4 trial (NCT06390059) is currently evaluating the device in combination with immunotherapy in the metastatic setting, Picozzi noted. He concluded that the biology of the device interfaces exceptionally well with evolving treatment modalities, offering a promising new avenue for enhancing outcomes in a traditionally difficult-to-treat patient population.