Novocure (NASDAQ:NVCR), a global oncology company at the forefront of cancer treatment innovation, today announced positive topline results from its Phase 2 PANOVA-4 clinical trial.
The study evaluated the efficacy of Tumor Treating Fields (TTFields) therapy administered concomitantly with atezolizumab (Tecentriq®), gemcitabine, and nab-paclitaxel as a first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).
The PANOVA-4 trial successfully met its pre-specified primary endpoint, demonstrating a statistically significant improvement in the disease control rate (DCR) compared to historical controls.
In the 78 patients treated with the TTFields combination, the DCR reached 74.4%, a substantial increase over the 48% DCR observed in the landmark Phase 3 MPACT study used as the historical reference.
This 26.4% difference yielded a 1-sided p-value of less than 0.001, highlighting the potential of the multi-modal approach to stabilize or reduce tumor burden in one of the most aggressive forms of cancer.
Secondary endpoints also provided encouraging signals for the combination therapy.
The objective response rate (ORR) for the PANOVA-4 cohort was 34.6%, while the median overall survival (OS) reached 9.7 months.
Clinical investigators noted that TTFields therapy was well-tolerated throughout the study, with a median therapy duration of 25.6 weeks.
The safety profile remained consistent with prior clinical applications of the device, with no new or unexpected treatment-emergent adverse events related to the technology.