Abstract 4255
Background
Tumor Treating Fields (TTFields) are an anti-mitotic, regional treatment modality, utilizing low intensity alternating electric fields delivered non-invasively to the tumor. TTFields have significantly extended survival of patients with glioblastoma. In vitro, human MPM cells are highly susceptible to TTFields. In the phase 2 STELLAR study [NCT02397928], patients with unresectable MPM treated with first line chemotherapy in combination with TTFields had a significantly higher median overall survival compared with historical controls (18.2 Vs. 12.1 months). We report on radiological data from STELLAR patients whose tumors responded while receiving the combined therapy.
Methods
The STELLAR trial accrued 80 patients with unresectable, previously untreated MPM. Patients received continuous 150 kHz TTFields (>18h/day) combined with pemetrexed and cisplatin or carboplatin (standard dosing). Inclusion criteria: ECOG PS of 0-1, pathologically proven MPM and > measurable lesion per modified RECIST. Patients were followed q3w (CT scan q6w) until disease progression. Radiological assessments were done 6-weekly at study sites.
Results
Partial responses (PRs) were seen in 40.3% (29/72) of evaluable patients and clinical benefit (PR+SD) was seen in 97.2% (70/72) patients. The median time between treatment start and PR was 1.9 months (range: 1.4-4.4 months). All patients presenting with PR during the STELLAR study had continuous reduction in the total sum of lesion diameters, suggesting no initial/pseudo-progression. 83% of the patients who responded to the combined therapy finally had disease progression with a median response duration of 5.7 months (range: 1.4-13 months). One patient did not progress for more than 27 months. 28 responders (97%) reported at least 1 adverse event, and 7 patients (24%) had TTFields-related skin toxicities.
Conclusions
The STELLAR study significantly extended survival in previously untreated MPM patients. Response rates were similar to those reported for the current MPM standard of care treatment, but were of longer duration with the addition of TTFields. The only TTFields-related adverse event was skin irritation beneath the arrays.
Clinical trial identification
NCT02397928.
Editorial acknowledgement
Legal entity responsible for the study
Novocure.
Funding
Novocure.
Disclosure
F. Grosso: Travel / Accommodation / Expenses: Novocure. G.L. Ceresoli: Travel / Accommodation / Expenses: Novocure.
Resources from the same session
2182 - Evaluating the prevalence of the expression of PD-L1 in NSCLC specimens with short-duration formalin fixation using IHC 22C3 pharmDx
Presenter: Keiichi Ota
Session: Poster Display session 1
Resources:
Abstract
5255 - [18F]-FDG PET/CT in predicting PD-L1 status in nasopharyngeal carcinoma
Presenter: Liang Zhao
Session: Poster Display session 1
Resources:
Abstract
4910 - Expression of PD-L1 in Chinese Patients with Common Cancers
Presenter: Min Zheng
Session: Poster Display session 1
Resources:
Abstract
4227 - The clearance of EGF by tumor-associated macrophages is suppressed by chemotherapeutic agent cisplatin
Presenter: Irina Larionova
Session: Poster Display session 1
Resources:
Abstract
5222 - VHIO-300 and a thousand one nights, a tale of Precision Medicine
Presenter: Ginevra Caratù
Session: Poster Display session 1
Resources:
Abstract
5668 - Matched Whole-Genome Sequencing and Whole-Exome Sequencing with Circulating Tumor DNA (ctDNA) Analysis are complementary modalities in clinical practice
Presenter: Robin Imperial
Session: Poster Display session 1
Resources:
Abstract
5772 - Exploring the role of genes associated with familial cancer syndromes on the development of multiple primary tumors
Presenter: Atanaska Mitkova
Session: Poster Display session 1
Resources:
Abstract
4784 - Doxorubicin resistance: early and advanced tumors can use two different strategies based on initial and profound abnormalities in microRNA expression signature
Presenter: Volodymyr Halytskiy
Session: Poster Display session 1
Resources:
Abstract
3456 - From tumor transcriptomes to underlying cell type proportions to better predict prognosis and response to treatments
Presenter: Yuna Blum
Session: Poster Display session 1
Resources:
Abstract
4976 - Optimization of automated germline DNA extraction from non-tumoral formalin-fixed paraffin embedded (FFPE) tissues
Presenter: Omar Youssef
Session: Poster Display session 1
Resources:
Abstract