Mesothelioma patients who received Tumor Treating Fields with
pemetrexed and cisplatin or carboplatin experienced median overall
survival of 18.2 months compared to 12.1 months in historical control
with no increase in systemic toxicity
Data will be highlighted in an oral presentation at world’s largest
meeting dedicated to lung cancer and other thoracic malignancies
ST. HELIER, Jersey--(BUSINESS WIRE)--
Novocure (NASDAQ: NVCR) announced today that results from its STELLAR
phase 2 registration trial in mesothelioma will be highlighted in an
oral presentation at the IASLC 19th World Conference on Lung Cancer
hosted by the International Association for the Study of Lung Cancer
(IASLC) on Sept. 25, 2018, in Toronto.
The STELLAR data demonstrated a significant extension in median overall
survival among patients treated with Tumor Treating Fields plus standard
of care chemotherapy compared to historical control data of patients who
received standard of care chemotherapy alone. Malignant pleural
mesothelioma patients who received Tumor Treating Fields with pemetrexed
and cisplatin or carboplatin experienced median overall survival of 18.2
months (95 percent CI, 12.1-25.8 months) compared to 12.1 months in a
historical control. Tumor Treating Fields is a cancer therapy that uses
electric fields tuned to specific frequencies to disrupt cell division,
inhibiting tumor growth and causing affected cancer cells to die.
“Mesothelioma is an aggressive cancer with limited treatment options,”
said Mary Hesdorffer, Nurse Practitioner and Executive Director of the
Mesothelioma Applied Research Foundation (MARF). “We in the mesothelioma
community are extremely pleased to see these promising data presented at
the IASLC 19th World Conference on Lung Cancer, the world’s
largest meeting dedicated to lung cancer and other thoracic
malignancies. At MARF, we work every day to eradicate the life-ending
and vicious effects of mesothelioma.”
Secondary endpoints also were improved compared to the historical
control. Patients who received Tumor Treating Fields in combination with
pemetrexed and cisplatin or carboplatin experienced a median progression
free survival of 7.6 months (95 percent CI, 6.7-9.8 months) compared to
5.7 months in the historical control. Partial responses were seen in
40.3 percent of patients, and clinical benefit, either partial response
or stable disease, was seen in 97.2 percent of patients. No serious
device-related adverse events were reported. Skin irritation was
reported in 46 percent of patients using Tumor Treating Fields, with
only 4 patients (5 percent) reporting grade 3 skin irritation.
The single-arm, open-label, multi-center trial was designed to test the
efficacy and safety of Tumor Treating Fields in combination with
standard of care chemotherapy, pemetrexed combined with cisplatin or
carboplatin, in 80 patients with unresectable, previously untreated
malignant pleural mesothelioma. The primary endpoint was overall
survival and secondary endpoints were response rate, progression free
survival and adverse events. Median age of patients was 67, 84 percent
were male, 56 percent were smokers, 16 percent had metastatic disease,
44 percent had an ECOG PS of 1, and 66 percent had epithelioid
histology. The historical control for this trial was the 2003 pemetrexed
phase 3 registration trial, which had a similar percentage of patients
with epithelioid histology.
“Mesothelioma patients face a very poor prognosis with a median overall
survival of only 12 months,” said Charles B. Simone, Medical Director of
the Maryland Proton Treatment Center and Associate Professor of
Radiation Oncology at the University of Maryland School of Medicine in
Baltimore. “This extreme unmet need calls for progress. Based on these
data, I believe Tumor Treating Fields has the potential to improve
survival for people affected by malignant pleural mesothelioma.”
Novocure received a Humanitarian Use Device (HUD) designation for the
use of Tumor Treating Fields for the treatment of malignant pleural
mesothelioma in 2017 and plans to submit a Humanitarian Device Exemption
(HDE) application to the U.S. Food and Drug Administration (FDA) for
approval later this year.
Tumor Treating Fields is not approved by the FDA for use in patients
with malignant pleural mesothelioma.
Presentation details are below:
(MA12.06) STELLAR – Final Results of a Phase 2 Trial of TTFields with
Chemotherapy for First-Line Treatment of Malignant Pleural Mesothelioma.
G.L. Ceresoli, et al. 11:05 a.m. to 11:10 p.m. EDT Sept. 25. (Room 202
BD)
The following three posters on the application of Tumor Treating Fields
across multiple indications will also be presented at the IASLC 19th
World Conference on Lung Cancer:
-
(P2.01-70) Tumor Treating Fields and Radiosurgery for Supra- and/or
Infratentorial Brain Metastases (1-10) from NSCLC in the Phase 3 METIS
Study. U. Weinberg. 4:45 p.m. to 6 p.m. EDT Sept. 25. (Exhibit Hall)
-
(P2.01-105) Tumor Treating Fields Plus Standard of Care for Non-Small
Cell Lung Cancer Following Platinum Failure: Phase 3 LUNAR Study. U.
Weinberg. 4:45 p.m. to 6 p.m. EDT Sept. 25. (Exhibit Hall)
-
(P2.06-05) TTFields Applied to the Torso and Upper Abdomen: Safety
Meta-Analysis of 176 Patients from four Phase I-II Trials. G.L.
Ceresoli. 4:45 p.m. to 6 p.m. EDT Sept. 25. (Exhibit Hall)
About Malignant Pleural Mesothelioma
Malignant pleural mesothelioma is a rare thoracic solid tumor cancer
that has been strongly linked to asbestos exposure. It has a long
latency period of at least 20-30 years following exposure, and global
incidence is still increasing in countries where asbestos is still in
use. There are approximately 3,000 new cases of mesothelioma annually in
the United States. The prognosis of mesothelioma patients is very poor,
with a median overall survival of approximately 12 months in most
reported studies.
About Novocure
Novocure is an oncology company developing a profoundly different cancer
treatment utilizing a proprietary therapy called Tumor Treating Fields,
the use of electric fields tuned to specific frequencies to disrupt
solid tumor cancer cell division. Novocure’s commercialized product is
approved for the treatment of adult patients with glioblastoma. Novocure
has ongoing or completed clinical trials investigating Tumor Treating
Fields in brain metastases, non-small cell lung cancer, pancreatic
cancer, ovarian cancer and mesothelioma.
Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New
Hampshire, Malvern, Pennsylvania and New York City. Additionally, the
company has offices in Germany, Switzerland, Japan and Israel. For
additional information about the company, please visit www.novocure.com
or follow us at www.twitter.com/novocure.
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Novocure
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acordova@novocure.com
Source: Novocure