Source – Novocure
The Phase III PANOVA-3 trial, which is assessing Tumor Treating Fields (TTFields) therapy in combination with nab-paclitaxel and gemcitabine for patients with unresectable, locally advanced pancreatic cancer, has received a recommendation to proceed with the final analysis, as stated by Novocure.
The trial’s data monitoring committee (DMC) has reviewed both safety and efficacy data for all patients enrolled in the fully-enrolled clinical trial. Based on the interim analysis findings, the DMC has recommended moving forward with the final analysis.
TTFields are electric fields that exert physical force to kill cancer cells while sparing healthy cells due to their unique properties compared to cancer cells. TTFields have shown enhanced effects in various solid tumor types when used alone or in combination with chemotherapy, radiotherapy, immune checkpoint inhibition, or PARP inhibition.
“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. 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.”
– Asaf Danziger, Novocure’s Chief Executive Officer
In the pivotal PANOVA-3 trial, 556 adult patients with unresectable, locally advanced pancreatic adenocarcinoma were randomized to receive nab-paclitaxel and gemcitabine combined with TTFields therapy tuned to 150 kHz until disease progression, or the combination of nab-paclitaxel and gemcitabine alone.
Eligible patients were 18 years or older with a histological/cytological diagnosis of pancreatic adenocarcinoma in unresectable, locally advanced stage, with a life expectancy of at least 3 months and an ECOG performance score of 0-2. Patients were assigned by the investigator to receive gemcitabine with nab-paclitaxel and had the ability to independently operate the NovoTTF-200T System or with the assistance of a caregiver.
The primary endpoint being evaluated in the study is overall survival, and secondary endpoints include 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.
