Findings from an exploratory subgroup analysis in the phase 3 INNOVATE-3 trial suggest that Tumor Treating Fields plus paclitaxel may confer a survival benefit in patients who received only 1 prior line of therapy for platinum-resistant ovarian cancer.
Combining Tumor Treating Fields (TTFields) with paclitaxel did not reach the primary end point of overall survival (OS) in the treatment of patients with platinum-resistant ovarian cancer, according to a press release on final results from the phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 trial (NCT03940196).
The median OS was 12.2 months among 280 patients who received TTFields therapy plus paclitaxel vs 11.9 months in 278 patients who received paclitaxel on its own (HR, 1.008). Findings from an exploratory subgroup analysis highlighted that the experimental regimen may yield a potential survival benefit in those who received only 1 prior line of therapy. Investigators are conducting an ongoing assessment of data from the INNOVATE-3 trial that will include the subgroup analyses.
Treatment with TTFields was tolerable and produced no new safety signals in the INNOVATE-3 trial.
“Recurrent ovarian cancer is a particularly aggressive cancer and options for patients diagnosed with platinum-resistance remain extremely limited,” principal investigator Ignace Vergote, MD, PhD, chairman of the Belgium and Luxembourg Gynaecological Oncology Group and professor at the Catholic University of Leuven, Belgium, said in the press release. “We are committed to continuing research with TTFields and exploring innovative approaches to treat this area of immense unmet need, and we are extremely grateful to all the investigators and patients for their participation in these studies.”
Investigators of the open-label randomized INNOVATE-3 trial assessed patients who received up to 5 prior lines of systemic therapy. Patients were randomly assigned to receive 80 mg/m2 of paclitaxel intravenously for 8 weeks then on days 1, 8, and 15 of each subsequent 28-day cycle with or without continuous TTFields therapy. Treatment with TTFields consisted of wearing 4 electrically insulated electrode arrays on the abdomen or pelvis.
The trial’s secondary end points included progression-free survival, objective response rate, adverse effects, time to undisputable deterioration in health-related quality of life (QOL) or death, and QOL.
Patients 18 years and older with epithelial histology of ovarian or primary peritoneal or fallopian tube carcinoma and a life expectancy of at least 12 months were able to enroll on the trial. Additional eligibility criteria included having up to 5 prior lines of systemic therapy, an ECOG performance status of 0 or 1, and evaluable disease in the abdominal or pelvic region per RECIST v1.1 criteria.
Those with prior disease progression on treatment with weekly paclitaxel for recurrent disease or brain metastasis or leptomeningeal spread of the tumor were not able to enroll on the trial. Patients were also unable to enroll if they had grade 3 or higher peripheral neuropathy, known allergies to medical adhesives or hydrogel, serious comorbidities, or concurrent anti-tumor treatment beyond weekly paclitaxel outside of hormonal therapy for breast cancer.
“While the final results of the INNOVATE-3 trial differ from our initial expectation, these data add important context to the treatment paradigm. We see treatment exposure and number of prior therapies are relevant and can drive outcomes, and we will leverage these data as we explore and identify new opportunities to treat this deadly disease,” David O’Malley, MD, professor of Obstetrics and Gynecology at The Ohio State University Wexner College of Medicine and director of the Division of Gynecologic Oncology at The James Comprehensive Cancer Center, concluded.
Novocure provides update on phase 3 ENGOT-ov50 / GOG-3029 / INNOVATE-3 trial evaluating Tumor Treating Fields therapy in platinum-resistant ovarian cancer. News release. Novocure. August 28, 2023. Accessed August 28, 2023. https://shorturl.at/inAT0