Abstract 4306
Background
Tumour Treating Fields (TTFields) are a non-invasive, regional antimitotic therapy. In preclinical models of ovarian cancer, TTFields (200 kHz) reduced cell viability and showed synergistic effects with taxanes in vitro and in vivo. The Phase 2 INNOVATE study [NCT02244502] demonstrated safety of TTFields plus weekly paclitaxel in 31 PROC (platinum-resistant ovarian cancer) patients (Vergote et al Gyn Onc 2018;150:471). No increase in grade 3–4 TTFields were reported; 26 patients (84%) had TTFields-related dermatitis; one patient permanently discontinued TTFields due to dermatitis. Patients received median of 4 prior therapies; 100% prior platinum and 97% prior taxanes. Median PFS was 8.9 months, 25% had partial response and clinical benefit rate was 71%. The median overall survival was not reached: the one-year survival rate was 61%. This phase 3 INNOVATE-3/ENGOT-ov50 study [NCT03940196] investigates TTFields combined with weekly paclitaxel in PROC patients.
Trial design
Patients (N = 540) will have disease progression (PROC per RECIST V1.1) within 6 months of last platinum therapy with a maximum of 2-5 prior lines of systemic therapy, ECOG score of 0-1 and no peripheral neuropathy above grade1. Patients with primary refractory disease (progression during first line therapy) will be excluded. Patients will be randomized 1:1 to either weekly paclitaxel alone or weekly paclitaxel plus TTFields (200 kHz). Weekly paclitaxel will be administered at standard starting of dose 80 mg/m2 weekly for 8 weeks, and then on Days 1, 8, and 15 for subsequent 28-day cycle. TTFields will be delivered for 18 hours/day and continued if no progression in the abdominal or pelvic regions (“in-field region”) per RECIST V1.1. Clinical follow up will be performed q4w, with radiological follow up (CT or MRI scans of the abdomen and chest) q8w. The primary endpoint is overall survival. Main secondary endpoints: progression-free survival, objective response rate, severity and frequency of AEs, and quality of life (EORTC QLQ-C30 with QLQ-OV28). Sample size (n = 540) will detect an increase in median overall survival from 12 to 16 months (Hazard ratio 0.75).
Clinical trial identification
ENGOT/ov50; NCT03940196.
Editorial acknowledgement
Legal entity responsible for the study
Novocure.
Funding
Novocure.
Disclosure
I.B. Vergote: Advisory / Consultancy: Roche NV, Genmab A/S, Advaxis Inc., Morphotek Inc., F. Hoffmann-La Roche Ltd.; Research grant / Funding (institution): Amgen and Roche; Advisory / Consultancy: Cerculean Pharma Inc., Novocure GmBh, AstraZeneca,; Advisory / Consultancy: Mateon Therapeutics Inc., Immunogen; Advisory / Consultancy: Eli Lilly Benelux NV, Amgen Inc., Theradex Europe; Advisory / Consultancy: Pfizer Inc., Debiopharma International SA, Vifor Pharma België; Advisory / Consultancy: Novartis Pharma AG, MSD Belgium BVBA, Janssen-Cilag; Advisory / Consultancy: Bayer Pharma AG, Clovis Oncology, Takeda, Pharma Mar, Oncoinvent; Travel / Accommodation / Expenses: Tesaro, Clovis Oncology, Takeda,; Travel / Accommodation / Expenses: Pharma Mar, Roche, Genmab and Oncoinvent. D. Cibula: Advisory / Consultancy: Roche, AstraZeneca, Sotio. V. Salutari: Honoraria (self) / Advisory role / Speaker Bureau: Roche, AstraZeneca, Tesaro, PharmaMar, MSD, Clovis. All other authors have declared no conflicts of interest.
Resources from the same session
3516 - Palbociclib Rechallenge in Hormone Receptor (HR)[+]/HER2[-] Advanced Breast Cancer (ABC). PALMIRA Trial
Presenter: Antonio Llombart Cussac
Session: Poster Display session 2
Resources:
Abstract
4616 - Alpelisib (ALP) + Endocrine Therapy (ET) by Last Prior Therapy in Patients (pts) With PIK3CA-Mutated Hormone-Receptor Positive (HR+) Human Epidermal Growth Factor Receptor-2-Negative (HER2–) Advanced Breast Cancer (ABC): Additional Study Cohort in BYLieve
Presenter: Eva Ciruelos
Session: Poster Display session 2
Resources:
Abstract
3592 - PRECYCLE: Impact of CANKADO-based eHealth-support on quality of life in metastatic breast cancer patients treated with palbociclib and endocrine therapy.
Presenter: Tom Degenhardt
Session: Poster Display session 2
Resources:
Abstract
4168 - Efficacy and safety of oral poly (ADP-ribose) polymerase inhibitor fluzoparib in patients with BRCA1/2 mutations and platinum sensitive recurrent ovarian cancer
Presenter: Ning Li
Session: Poster Display session 2
Resources:
Abstract
2785 - Effect of response to last platinum-based chemotherapy in patients (pts) with platinum-sensitive, recurrent ovarian carcinoma in the phase 3 study ARIEL3 of rucaparib maintenance treatment
Presenter: Jonathan Ledermann
Session: Poster Display session 2
Resources:
Abstract
3496 - Integrated safety analysis of the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib in patients (pts) with ovarian cancer in the treatment and maintenance settings
Presenter: Rebecca Kristeleit
Session: Poster Display session 2
Resources:
Abstract
2844 - Clinical factors associated with prolonged response and survival under olaparib as maintenance therapy in BRCA mutated ovarian cancers
Presenter: S.Intidhar Labidi-Galy
Session: Poster Display session 2
Resources:
Abstract
1955 - A Prospective Evaluation of Tolerability of Niraparib Dosing Based on Baseline Body Weight (BW) and Platelet (plt) Count: Blinded Pooled Interim Safety Data from the NORA Study
Presenter: Xiaohua Wu
Session: Poster Display session 2
Resources:
Abstract
2539 - Evaluation of Niraparib 200 mg/d as Maintenance Therapy in Recurrent Ovarian Cancer and Associated Thrombocytopenia in a Real-World US Setting
Presenter: Premal Thaker
Session: Poster Display session 2
Resources:
Abstract
1290 - Niraparib initial dose and its’ management in patients with recurrent high-grade serous ovarian cancer.
Presenter: Jacek Grabowski
Session: Poster Display session 2
Resources:
Abstract