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The phase 3 PANOVA-3 trial assessing Tumor Treating Fields (TTFields) therapy with nab-paclitaxel and gemcitabine has been given the recommendation to continue with the final analysis for the treatment of patients with unresectable, locally advanced pancreatic cancer, according to Novocure.1
The data monitoring committee (DMC) of the trial reviewed both the safety and efficacy data for all patients in the fully-enrolled clinical trial, and based on findings from the interim analysis, the trial has been given the recommendation to proceed to final analysis.
"Completion of the interim analysis with the DMC’s recommendation to continue PANOVA-3 to completion marks another important step in pursuit of our mission to treat patients with difficult solid tumors of the abdomen," said Asaf Danziger, chief executive officer of Novocure, in a press release. "I would like to express my thanks to our patients and investigators. We look forward to reviewing the PANOVA-3 data in 2024 and potentially extending the lives of patients diagnosed with deadly locally advanced pancreatic cancer by treating with our novel therapy, Tumor Treating Fields."
TTFields are electric fields that kill cancer cells by exerting physical force. Since they have different properties compared with cancer cells, TTFields do not significantly affect healthy cells. Additionally, TTFields have multiple, distinct mechanisms which work together to selectively target and kill cancer cells.
Based on prior research, this therapy can be added to cancer treatment modalities in approved indications as it exhibits enhanced effects across solid tumor types when used alone or combined with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition.
In the pivotal, randomized, open-label, PANOVA-3 trial, 556 adult patients with unresectable, locally advanced pancreatic adenocarcinoma were enrolled and randomized to receive either nab-paclitaxel and gemcitabine combined with TTFields therapy tuned to 150 kHz until progression, or the combination of nab-paclitaxel and gemcitabine alone.2
Patients aged 18 years and older with a histological/cytological diagnosis of pancreatic adenocarcinoma with unresectable, locally advanced stage disease were enrolled in the study if they had a life expectancy of ≥ 3 months and an ECOG performance score 0-2. Patients also must have been assigned by the investigator to receive gemcitabine with nab-paclitaxel, and be able to operate the NovoTTF-200T System independently or with the help of a caregiver.
The primary end point being evaluated in the study is overall survival, and secondary end points are 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 profile.
The final patient was enrolled in the study in February 2023. From this time point, patients will be followed for a minimum of 18 months.
Novocure announces favorable independent data monitoring committee recommendation to continue phase 3 PANOVA-3 clinical trial of tumor treating fields therapy in pancreatic cancer. News release. Novocure. July 21, 2023. Accessed July 24, 2023. https://tinyurl.com/29sjxe7n
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 April 10, 2023. Accessed July 24, 2023. https://classic.clinicaltrials.gov/ct2/show/NCT03377491