On October 16, 2019 Novocure (NASDAQ: NVCR) reported that results from the STELLAR trial were published in The Lancet Oncology (Press release, NovoCure, OCT 16, 2019, View Source [SID1234542313]). The STELLAR trial was a prospective, single-arm trial including 80 patients that studied the use of Tumor Treating Fields, delivered via the NovoTTF-100L System, in combination with pemetrexed plus cisplatin/carboplatin as a first-line treatment for patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM).
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Data showed a median overall survival of 18.2 months (95 percent CI, 12.1 months-25.8 months) for patients treated with NovoTTF-100L and pemetrexed plus cisplatin or carboplatin. One- and two-year survival rates were 62.2 percent (95 percent CI, 50.3 percent-72.0 percent) and 41.9 percent (95 percent CI, 28.0 percent-55.2 percent), respectively. No serious systemic adverse events were considered to be related to the use of NovoTTF-100L. The most common mild to moderate adverse event was skin irritation beneath the transducer arrays.
"The STELLAR trial demonstrated encouraging overall survival results with no increase in systemic toxicity observed in MPM patients treated with Tumor Treating Fields and standard chemotherapy," said Giovanni Luca Ceresoli, MD, Head of Pulmonary Oncology at the Humanitas Gavazzeni Hospital in Bergamo, Italy, and Principal Investigator in the STELLAR trial. "The median overall survival of 18.2 months is impressive given that MPM is a tumor with a dismal prognosis and few effective therapeutic options."
"Mesothelioma is an aggressive cancer that is extremely difficult to treat," said Rupesh Kotecha, MD, Chief of Radiosurgery, Radiation Oncology, Miami Cancer Institute in Florida. "With such limited treatment options, I’m encouraged by the FDA approval of NovoTTF-100L, adding another therapy with the potential to improve outcomes for people with unresectable MPM."
Median progression free survival was 7.6 months (95 percent CI, 6.7 months-8.6 months) for patients treated with NovoTTF-100L and pemetrexed plus cisplatin or carboplatin. There was a 97 percent disease control rate in patients with at least one follow-up CT scan performed (n=72). 40 percent of patients had a partial response, 57 percent had stable disease and 3 percent had progressive disease.
"MPM patients are in need of better treatment options," said Novocure CEO Asaf Danziger. "We are proud that NovoTTF-100L is the first FDA-approved therapy for MPM in more than 15 years. We hope it is just the beginning of continued innovation for patients with this disease."
About Malignant Pleural Mesothelioma (MPM)
Malignant pleural mesothelioma is a rare thoracic solid tumor cancer that has been strongly linked to asbestos exposure. Mesothelioma has a long latency period of 47.9 years on average for men and 53.3 years on average for women following asbestos exposure. There are approximately 3,000 new cases of mesothelioma annually in the United States. Globally, more than 14,000 people are diagnosed with mesothelioma each year. Global mesothelioma incidence is increasing in countries where asbestos is still in use. The prognosis of mesothelioma patients is very poor.
About STELLAR
STELLAR was a phase 2, prospective, single-arm trial designed to study the safety and efficacy of NovoTTF-100L, a Tumor Treating Fields delivery system, and pemetrexed plus cisplatin or carboplatin as a first-line treatment for 80 patients with unresectable, locally advanced or metastatic malignant pleural mesothelioma (MPM). The trial was designed for patients to receive Tumor Treating Fields at 150 kHz at least 18 hours a day until disease progression. The primary endpoint of the trial was overall survival. Secondary endpoints included objective response rate, progression-free survival and safety.
Eligible patients had no prior chemotherapy or radiation treatment for MPM, were at least 18 years old, had an Eastern Cooperative Oncology Group performance status of 0-1, and had at least one measurable or evaluable lesion according to the modified RESIST criteria. Adequate hepatic, renal and hematological functions were required, as well as a life expectancy of at least 3 months. The study was conducted at 12 sites in Europe.
About the NovoTTF-100L System
NovoTTF-100L is a noninvasive, antimitotic cancer treatment for MPM. NovoTTF-110L delivers Tumor Treating Fields to the region of the tumor.
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. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.
Caution: Federal law restricts this device to sale by or on the order of a physician. Humanitarian Device. Authorized by Federal Law for use in the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma concurrently with pemetrexed and platinum-based chemotherapy. The effectiveness of this device for this use has not been demonstrated.
Approved Indications
The NovoTTF-100L System is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy.
Important Safety Information
Contraindications
Do not use the NovoTTF-100L System in patients with implantable electronic medical devices such as pacemakers or implantable automatic defibrillators, etc. Use of the NovoTTF-100L System together with implanted electronic devices has not been tested and may lead to malfunctioning of the implanted device.
Do not use the NovoTTF-100L System in patients known to be sensitive to conductive hydrogels. Skin contact with the gel used with the NovoTTF-100L System may commonly cause increased redness and itching, and may rarely lead to severe allergic reactions such as shock and respiratory failure.
Warnings and Precautions
The NovoTTF-100L System can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure.
The most common (≥10%) adverse events involving the NovoTTF-100L System in combination with chemotherapy were anemia, constipation, nausea, asthenia, chest pain, fatigue, medical device site reaction, pruritus, and cough.
Other potential adverse effects associated with the use of the NovoTTF-100L System include: treatment related skin toxicity, allergic reaction to the plaster or to the gel, electrode overheating leading to pain and/or local skin burns, infections at sites of electrode contact with the skin, local warmth and tingling sensation beneath the electrodes, muscle twitching, medical device site reaction and skin breakdown/skin ulcer.
If the patient has an underlying serious skin condition on the chest, evaluate whether this may prevent or temporarily interfere with the NovoTTF-100L System treatment.
Do not prescribe the NovoTTF-100L System for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of the NovoTTF-100L System in these populations have not been established.
Please visit www.novottf100l.com to see the NovoTTF-100L System Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.