On September 25, 2018 Novocure (NASDAQ: NVCR) reported 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 (Press release, NovoCure, SEP 25, 2018, View Source [SID1234529575]).
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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.
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