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
1058 - Assessment of CPS+EG, Neo-Bioscore and modified Neo-Bioscore in breast cancer patients treated with preoperative systemic therapy: a multicenter cohort study
Presenter: LING XU
Session: Poster Display session 2
Resources:
Abstract
1156 - The concordance of treatment decision guided by Oncotype and the PREDICT tool in early stage breast cancer
Presenter: Hadar Goldvaser
Session: Poster Display session 2
Resources:
Abstract
3447 - Influence of first treatment delay on survival among breast cancer subtypes
Presenter: Irene Zarcos Pedrinaci
Session: Poster Display session 2
Resources:
Abstract
3505 - Clinical features of early-stage (I-III) triple-negative breast cancer (TNBC) patients with tumors exhibiting low-overall change in molecular profile after neoadjuvant therapy.
Presenter: Nour Abuhadra
Session: Poster Display session 2
Resources:
Abstract
5442 - Meta-analysis in HER2+ early breast cancer therapies and cost-effectiveness in a Brazilian perspective
Presenter: Marcos Magalhaes
Session: Poster Display session 2
Resources:
Abstract
1570 - Anti-mullerian hormone (AMH) levels and antral follicle counts (AFC) may predict ovarian reserves before systemic chemotherapy (SC) in women with breast cancer(BC); a prospective clinical study
Presenter: Cetin Ordu
Session: Poster Display session 2
Resources:
Abstract
2698 - Prognosis of selected triple negative apocrine breast cancer patients who did not receive adjuvant chemotherapy.
Presenter: Giuseppe Cancello
Session: Poster Display session 2
Resources:
Abstract
3104 - Novel Blood Based Circulating Tumor Cell Biomarker For Breast Cancer Detection
Presenter: Chun-Yu Liu
Session: Poster Display session 2
Resources:
Abstract
4631 - Multi-Gene Prognostic Signatures and Prediction of Pathological Complete Response of ER-Positive HER2-Negative Breast Cancer Patients to Neo-Adjuvant Chemotherapy
Presenter: Claudia Mazo
Session: Poster Display session 2
Resources:
Abstract
4632 - Impact of menopause status on breast cancer outcomes and amenorrhea incidence during adjuvant tailored dose dense chemotherapy
Presenter: Andri Papakonstantinou
Session: Poster Display session 2
Resources:
Abstract