This is a shortened version of an article written by Kristi Rosa and published in OncLive March 24, 2022
An independent data monitoring committee (DMC) has recommended that the phase 3 INNOVATE-3 trial exploring the safety and efficacy of tumor treating fields (TTFields) in combination with paclitaxel in patients with platinum-resistant ovarian cancer proceed to the final analysis, according to an announcement from Novocure.
The recommendation follows a review of safety findings for all the patients enrolled to the trial, and an analysis of overall survival (OS) that was done on the first 540 patients who underwent randomization. Data from the prespecified interim analysis of the trial did not signal for a need to increase the sample size, and so the trial will continue 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, stated in a press release. “I would like to thank our investigators and collaborators, ENGOT and The GOG Foundation, as well as our patients for their passion and bravery. We look forward to reviewing final data next year.”
TTFields are electric fields that disturb cancer cell division. These fields can hinder electrically charged cellular components of cancer cells and disrupt their function, which could result in cell death. With this approach, cancer cell division can either be slowed down or stopped. Utilizing the investigational medical device referred to as NovoTTF-200(O), the fields are delivered to the region of the body where the tumor is located. [Learn more about TTFields here]
The pivotal, open-label, phase 3 INNOVATE trial enrolled patients with a histologically confirmed diagnosis of ovarian carcinoma that has been unresponsive to therapy containing platinum within 6 months of their last treatment, who are at least 18 years of age and have a life expectancy of at least 12 weeks. 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 [overall survival], and key secondary end points include progression-free survival (PFS), objective response rate, severity and frequency of adverse effects, time to deterioration in health-related quality of life (QOL) or death, and QOL.
As of October 2021, the study has accrued a total of 540 patients. Data from the trial are anticipated to be reviewed in 2023, after an 18-month follow-up period.
Previously, TTFields in combination with weekly paclitaxel was observed in patients with platinum-resistant ovarian cancer as part of the single-arm, phase 2 INNOVATE trial (NCT02244502).
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