Tumor Treating Fields Show Significant Survival Benefit in Pancreatic Cancer

cancer of pancreas : © Dr_Microbe - stock.adobe.com

A statistically significant improvement in overall survival (OS) was observed in patients with unresectable, locally advanced pancreatic adenocarcinoma (PDAC) given tumor treating fields (TTFields) concomitant with gemcitabine and nab-paclitaxel vs the doublet alone in the first-line setting, meeting the primary end point of the PANOVA-3 trial (NCT03377491).¹

Overall, PANOVA-3 randomized 571 patients to gemcitabine and nab-paclitaxel either alone or combined with TTFields. In the intent-to-treat population, the TTFields regimen led to a median OS of 16.20 months vs 14.16 months for those treated with gemcitabine and nab-paclitaxel alone, making for a statistically significant 2.0-month improvement (HR, 0.819; P =.039). Among those treated with TTFields therapy, the survival benefit rate increased over time with a 13% and 33% improvement in the OS rate at 12 and 24 months, respectively.

For safety, treatment with TTFields was well tolerated, and findings were consistent with what has previously been seen in clinical trials.

“As a researcher and clinician, I have experienced the challenges of developing treatments in pancreatic cancer. It is exciting to see the PANOVA-3 trial achieve the positive primary end point of overall survival, a landmark outcome for this field,” said Vincent Picozzi, MD, medical oncologist and investigator in the PANOVA-3 trial, in a press release. “These data for tumor treating fields are very promising, especially in this difficult to treat patient population.”

Full data from the PANOVA-3 study are expected to be presented at an upcoming medical meeting.¹

Novocure, the company developing TTFields along with Zai Lab Limited, plans to file for regulatory approval of TTFields in the US, European Union, Japan, and other key markets for the treatment of unresectable, locally advanced PDAC. Further, patients continue to be followed in the phase 2 PANOVA-4 trial (NCT06390059), which is evaluating the combination of TTFields therapy with atezolizumab (Tecentriq), gemcitabine, and nab-paclitaxel for the potential treatment of patients with metastatic pancreatic cancer. This study has completed enrollment and is expected to present data in 2026.

“PANOVA-3 is the first and only phase 3 trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer, and is Novocure’s third positive phase 3 clinical trial in the last 2 years,” said Nicolas Leupin, MD, PhD, chief medical officer of Novocure, in the press release. “We are grateful to the patients and investigators for their participation in the trial, and we look forward to sharing the full data at an upcoming medical conference.”

About the PANOVA-3 Trial

PANOVA-3, a prospective, randomized, open-label, controlled, phase 3 trial, was designed to examine the safety and efficacy of TTFields therapy given concomitantly with gemcitabine and nab-paclitaxel in the first-line for the treatment of patients with locally advanced PDAC. A total of 571 patients were enrolled in the study and randomized in a 1:1 fashion.²

Patients were randomly assigned to receive either TTFields therapy concomitant with gemcitabine and nab-paclitaxel or gemcitabine and nab-paclitaxel alone. They were then followed for a minimum of 18 months. Gemcitabine was given at a dose of 1000 mg/m² over 30 minute infusions and was administered immediately post nab-paclitaxel on days 1, 8, and 15 of each 28-day cycle. Nab-paclitaxel was given at 125 mg/m² via intravenous infusion over 30 to 40 minutes on days 1, 8, and 15 of each 28-day cycle.

Enrollment was open to patients 18 years of age and older with a histological or cytological diagnosis of de novo adenocarcinoma of the pancreas and unresectable, locally advanced stage disease. Patients had to have a life expectancy of at least 3 months and an ECOG performance score of 0, 1, or 2.

In addition to the primary end point of OS, secondary end points consist of progression-free survival (PFS), local PFS, objective response rate, 1-year survival rate, quality of life, pain-free survival, puncture-free survival, resectability rate, and toxicity.

REFERENCES:

1. Novocure announces positive topline results from phase 3 PANOVA-3 clinical trial of tumor treating fields (TTFields) therapy for pancreatic cancer. News release. Novocure. December 2, 2024. Accessed December 2, 2024. https://tinyurl.com/23dprpp6

2. Effect of tumor treating fields (TTFields, 150 kHz) as front-line treatment of locally-advanced pancreatic adenocarcinoma concomitant with gemcitabine and nab-paclitaxel (PANOVA-3). ClinicalTrials.gov. Updated October 31, 2024. Accessed December 2, 2024. https://clinicaltrials.gov/study/NCT03377491