Tumor treating fields in combination with paclitaxel in patients with platinum-resistant ovarian cancer, has been recommended by an independent data monitoring committee to proceed to the final analysis based on data from the phase 3 INNOVATE-3 trial.
The phase 3 INNOVATE-3 trial (ENGOT-ov50; NCT03940196) which explores the safety and efficacy of tumor treating fields (TTFields) in combination with paclitaxel in patients with platinum-resistant ovarian cancer, has been recommended by an independent data monitoring committee (DMC) to proceed to the final analysis, according to an announcement from Novocure.1
The recommendation follows the results of the prespecified interim analysis which reviewed the safety findings for all the patients enrolled to the trial, as well as an analysis of overall survival (OS) performed on the first 540 patients who underwent randomization. Data from the interim analysis did not show a need to increase the sample size, resulting in the trial continuing as planned.
“Completion of the DMC interim analysis represents the next milestone in our journey to address the significant unmet need for patients diagnosed with platinum-resistant ovarian cancer,” Ely Benaim, MD, chief medical officer of Novocure, said in a press release. “…We look forward to reviewing final data next year.”
The phase 3 INNOVATE trial is designed to evaluate the safety and efficacy of TTFields, electric fields that disturb cancer cell division, in combination with paclitaxel in patients with platinum-resistant ovarian cancer.2,3 TTFields are able to hinder electrically charged cellular components of cancer cells and disrupt function, which could result in cell death. Using this approach can allow cancer cell division to either stop or slow down.
The pivotal, open-label study enrolled patients aged 18 and older with histologically confirmed ovarian carcinoma that has been unresponsive to therapy containing platinum within 6 months of their last treatment, have a life expectancy of at least 12 weeks, a maximum of 2 prior lines of systemic therapy following diagnosis of platinum-resistance, and an ECOG status of 0 or 1. Additionally, patients needed to be amenable to receive weekly paclitaxel and be able to operate the NovoTTF-200(O) device.
Study participants were randomized to receive either weekly paclitaxel alone or weekly paclitaxel concomitantly with TTFields tuned to 200 kHz until disease progression.
The primary end point of the trial is OS with key secondary end points including progression-free survival (PFS), objective response rate, time to deterioration in health-related quality of life (QOL) or death, severity and frequency of adverse effects, and QOL.
As of October 2021, the study currently has a total of 540 patient and data from the trial are anticipated to be reviewed after an 18-month follow-up period in 2023.