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Phase 3 Trial of Tumor Treating Fields and Concomitant Weekly Paclitaxel for the Treatment of Platinum-Resistant Ovarian Cancer

2020 Year in Review - Ovarian Cancer

The phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 study is exploring the use of an antimitotic therapy tumor treating (TT) fields plus weekly paclitaxel in patients with platinum-resistant ovarian cancer.

The use of TT fields is a noninvasive, antimitotic cancer therapy. In 31 patients with platinum-resistant ovarian cancer, the phase 2 INNOVATE study demonstrated the safety of TT fields/weekly paclitaxel.1 The median progression-free survival (PFS) was 8.9 months, 25% of patients had a partial response, and the clinical benefit rate was 71%. Although the median overall survival (OS) was not reached, the 1-year survival rate was 61%.1

Ignace Vergote and colleagues, presenting at the European Society of Gynaecological Oncology 2020 Virtual Conference, provided insight on the phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 study, exploring the use of TT fields plus weekly paclitaxel in patients with platinum-resistant ovarian cancer. Enrolled patients (N = 540) will have platinum-resistant ovarian cancer. The study will exclude patients with primary refractory disease. One-to-one randomization of patients to weekly paclitaxel alone or weekly paclitaxel (starting dose, 80 mg/m2 weekly for 8 weeks, and then on days 1, 8, and 15 for subsequent 28-day cycles) plus TT fields (200 kHz for 18 hours daily and continued if no progression in the abdominal or pelvic regions) will occur. Clinical follow-up will be performed every 4 weeks, with radiologic follow-up every 8 weeks. The primary end point is OS. Secondary end points are adverse events, objective response rate, PFS, and quality of life. An increase in median OS from 12 to 16 months (hazard ratio, <0.75) will be detected by a sample size of 540. No safety issues have been observed to date.

Source: Vergote I, et al. Int J Gynecol Cancer. 2020;30(4_suppl). Abstract 403.

1. Vergote I, von Moos R, Manso L, et al. Tumor treating fields in combination with paclitaxel in recurrent ovarian carcinoma: results of the INNOVATE pilot study. Gynecol Oncol. 2018;150:471-477.


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