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
1109 - First Canadian Interim Analysis from the Phase IIIb CompLEEment-1 Ribociclib + Letrozole HR+ HER2- Advanced Breast Cancer Trial
Presenter: Cristiano Ferrario
Session: Poster Display session 2
Resources:
Abstract
4401 - Real-world effectiveness of first-line palbociclib + letrozole for metastatic breast cancer 4 years post approval in the US
Presenter: Jonathan Kish
Session: Poster Display session 2
Resources:
Abstract
5876 - Palbociclib-Fulvestrant (PALBO-FUL) and Everolimus -Exemestane (EVE-EXE) for Second line Hormonal Treatment (HT) of Metastatic Breast Cancer (MBC) with Lobular Histology: a Propensity Score Matched Analysis of a Multicenter ‘Real-World’ Patients (pts) Series.
Presenter: Armando Orlandi
Session: Poster Display session 2
Resources:
Abstract
3587 - Dose-escalation study of G1T48, an oral selective estrogen receptor degrader (SERD), in postmenopausal women with ER+/HER2- locally advanced or metastatic breast cancer (ABC)
Presenter: E Dees
Session: Poster Display session 2
Resources:
Abstract
5696 - Final results of the STEM trial: SFX-01 in the Treatment and Evaluation of ER+ Her2- Metastatic breast cancer (mBC)
Presenter: Sacha Howell
Session: Poster Display session 2
Resources:
Abstract
1475 - Alpelisib (ALP) + Fulvestrant (FUL) in Hormone-Receptor Positive (HR+), Human Epidermal Growth Factor Receptor-2–Negative (HER2–) Advanced Breast Cancer (ABC): Subgroup Analysis by Presence of Visceral Metastasis (VM) in the SOLAR-1 Trial
Presenter: Mario Campone
Session: Poster Display session 2
Resources:
Abstract
2549 - Phase 1 Dose Escalation Study of a Selective Androgen Receptor Modulator RAD140 in Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) Breast Cancer (BC)
Presenter: Erika Hamilton
Session: Poster Display session 2
Resources:
Abstract
3787 - A Phase I study of XZP-3287, a novel oral CDK4/6 Inhibitor, administered on a continuous dosing schedule, in patients with advanced solid tumours
Presenter: Binghe Xu
Session: Poster Display session 2
Resources:
Abstract
4835 - Phase-I dose-escalation and expansion study of the PARP inhibitor, fluzoparib (SHR3162), in patients with advanced solid tumors
Presenter: Huiping Li
Session: Poster Display session 2
Resources:
Abstract
5083 - Phase 2 study of DHP107 (Liporaxel®, oral paclitaxel) in first-line, HER2 negative recurrent/metastatic breast cancer (OPTIMAL study, NCT03315364)
Presenter: Jin-Hee Ahn
Session: Poster Display session 2
Resources:
Abstract