Category: Treatments

Combination of Electric Fields and Chemotherapy May Be A New Treatment Option for Pleural Mesothelioma Patients

• Lisa Hyde-Barrett
• Featured News, Research, Treatments

The key to increasing  survival for mesothelioma patients is to kill the cancer cells before they can spread to other organs. Treatment options, including surgery, chemotherapy and radiation, all contribute to a patient’s survival, but many times the prognosis remains unchanged. Now, one company has turned to experimenting with delivering electromagnetic waves to the chest of pleural mesothelioma patients and reports improvements in overall survival when combined with chemotherapy.

Novocure, a UK-based medical device company that develops and markets Tumor Treating Fields delivery systems,  developed the novel devices as an alternative way to destroy tumor cells while sparing healthy tissue. Already approved by the U.S. Food and Drug Administration for the treatment of brain cancer, the  device is now in a Phase II clinical trial for pleural mesothelioma patients.

In April, researchers gave an interim review of the STELLAR clinical trial reporting that the first 42 pleural mesothelioma patients treated with the combination of Tumor Treating Fields (TTF) and pemetrexed and cisplatin or carboplatin had a one-year survival rate of 80 percent, compared to 50 percent in the chemotherapy only patients. Median progression free survival was 7.3 months versus just 5.7 months in the chemotherapy controlled group.

“We are extremely pleased with these top-line results, which bring us one step closer to realizing the potential for a new treatment for mesothelioma patients in desperate need,” said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development, in an April 17 press release.

The NovoTTF-100L device used in the clinical trial provides mesothelioma patients with a round-the-clock treatment option that allows them to maintain an active lifestyle without interference to activities such as walking outdoors, shopping, and cleaning. Connected to the patient via insulated electrode arrays placed on the upper torso, the device delivers low-intensity alternating electric fields to the region near the mesothelioma tumors. The TTF is inconspicuous and  light enough to carry to most functions and activities. The device needs to be active approximately 18 hours a day. According to the company’s website there are no limiting side effects.

“Mesothelioma is the first torso indication for which Novocure will pursue FDA approval,” said Dr. Kirson.

Novocure previously received a Humanitarian Use Device (HUD) designation for the use of TTF  for pleural mesothelioma. The next step is to submit a Humanitarian Device Exemption (HDE) application to the FDA. For medical devices, an HDE exempts the businesses from proving effectiveness of the device. However, the company must show that the HUD “will not expose patients to an unreasonable or significant risk of illness or injury and the probable benefit to health from use of the device outweighs the risk of injury or illness from its use, ” according to the HDE application requirements.

Pleural mesothelioma, a rare form of cancer affecting the lining of the lungs, is highly aggressive and is resistant to many cancer treatments. Most often diagnoses are not made until symptoms appear and the disease has progressed to an advanced stage leaving the patient with life-threatening complications. 3,000 Americans are diagnosed with mesothelioma each year.

Sources :

• STELLAR clinical trial
  https://clinicaltrials.gov/ct2/show/NCT02397928
• Novocure’s Chief Science Officer and Head of Research and Development
  https://www.novocure.com/novocure-reports-positive-top-line-results-from-stellar-phase-2-pilot-trial-in-mesothelioma/
• NovoTTF-100L
  https://www.novocuretrial.com/stellar-mesothelioma/living-with-ttfields/
• Humanitarian Device Exemption
  https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/humanitariandeviceexemption/default.htm
• HDE application requirements
  https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/ucm563286.htm

ASCO Offers Malignant Pleural Mesothelioma Treatment Guidelines

• Nancy Meredith
• Pleural Mesothelioma, Treatments

The American Society of Clinical Oncology (ASCO) is the world’s leading professional organization for medical professionals caring for cancer patients. The Society has a goal to improve the quality of care in the field of oncology.  Now, to assist medical professionals managing patients with malignant pleural mesothelioma, the organization has just released new evidence-based recommendations.

In their newly released clinical practice guidelines, ASCO offers guidelines for diagnosis, staging, chemotherapy, surgical cytoreduction, radiation therapy, and multimodality therapy in malignant pleural mesothelioma (MPM) patients. According to the panel of experts, including Hedy L. Kindler, MD, of the University of Chicago, and Mary Hesdorffer, formerly the Executive Director of the Mesothelioma Applied Research Foundation, the recommendation addresses five “overarching clinical questions.”

• What is the optimal approach to obtain an accurate diagnosis of mesothelioma?
• What initial assessment is recommended before initiating any therapy for mesothelioma?
• What is the appropriate first- and second-line systemic treatment of patients with mesothelioma?
• What is the appropriate role of surgical cytoreduction in the management of mesothelioma?
• When should radiation be recommended for mesothelioma?

Pleural mesothelioma is a rare, painful cancer caused by exposure to airborne asbestos fibers. Treatments manage the symptoms to hold the cancer at bay, but there is no known cure for this deadly disease. Patients have a poor prognosis, and the median overall survival of patients with advanced surgically unresectable disease is about 12 months, according to ASCO. About 3,000 new cases are diagnosed each year in the U.S.

The ASCO team noted that “Given the rarity of this malignancy, there have been few large randomized trials, especially for surgical management of this disease.” Seeing a critical need to find and compile this information, ASCO convened a panel of experts, including thoracic, oncology and advocacy experts, to review medical literature published from 1990 through 2017 that included references to pertinent trials and studies.

Through the search of the literature, the team identified 222 relevant studies. After assessing the key areas of interest, including survival and quality of life, using evidence and informal consensus the team developed the evidence-based guideline recommendations.

The guidelines, published in the Journal of Clinical Oncology, include offering chemotherapy as a means for improving survival and quality of life for mesothelioma patients. The recommended first-line chemotherapy is pemetrexed plus platinum. However, the team recommends offering patients the option of enrolling in a clinical trial. Other chemotherapy recommendations include the addition of bevacizumab to pemetrexed-based chemotherapy for  select patients, as well as pointing out risks for the use in some patients.

The panel “strongly recommends” a maximal surgical cytoreduction surgery for certain patients with early-stage disease. The recommendations note, however, that surgery is just one modality and chemotherapy and/or radiation should also be administered.

See the Journal of Clinical Oncology for all of the mesothelioma recommendations.

ASCO states that “clinical practice guidelines are intended to improve the quality of cancer care by helping oncologists make choices about treatment, prevention, supportive care, or follow-up in line with the best available evidence from oncology research.” ASCO notes that the guidelines are voluntary and do not account for variation among patients or the most recent evidence.

Sources:

• ASCO
  https://www.asco.org/practice-guidelines/quality-guidelines/guidelines/thoracic-cancer#/29376
• Journal of Clinical Oncology
  http://jco.ascopubs.org/content/early/2012/12/13/JCO.2012.44.6443.abstract
  

Combination of Liquid Biopsy Tools Improves Results in Detecting Biomarkers, May Lead to Better Selection of Targeted Mesothelioma Treatments

• Nancy Meredith
• For Your Family, Pleural Mesothelioma, Research, Treatments

Researchers continue to look for an effective tool that can be used for the early detection of cancer and to track the effectiveness of treatment. Now, one company reports that by pairing its liquid biopsy analyzer tool with another company’s genetic data analysis tool, the resulting tests proved to be nearly 100% accurate. This is another step in using blood tests to help guide personalized medicine for lung cancer and pleural mesothelioma patients.

In a press release prior to the Fifth AACR-IASLC International Joint Conference held earlier this month in San Diego, Biocept, Inc, reports when it paired the Target Selector ctDNA lung cancer assays with the Thermo Fisher QuantStudio5 (QS5) real-time PCR instrument results of the detection of key lung cancer mutations resulted in “more than 99% sensitivity and more than 99% specificity.”

“The ability to rapidly and accurately assess the molecular status of a patient’s tumor using a simple blood draw can be a critical factor in the selection of individualized targeted therapy,” said Biocept’s Senior Vice President and Senior Medical Director Veena Singh, MD. “Our tests can further provide for the monitoring of response to therapy over time without invasive tissue biopsies that can be difficult to perform in patients diagnosed with cancer.”

The tests targeted EGFR, KRAS and BRAF mutations that have been shown to be present in lung cancer and in some pleural mesothelioma tumors as well. According to some reports, mutations of the KRAS gene (Kirsten rat sarcoma viral oncogene homolog) are found in 20 to 25 percent of lung cancers. The EGFR gene is overexpressed in more than 50% of pleural mesothelioma patients, and in approximately 15% of lung cancer patients, and is one of the primary targets for bringing personalized care to cancer patients.

With the advent of personalized therapies that target specific biomarkers, ensuring that effective tools are available to quickly and easily identify treatable mesothelioma markers is critical. Personalized cancer treatment optimizes the potential for success.

Often, lung cancer and mesothelioma patients must undergo invasive and painful biopsies to extract diseased tissue for diagnosis. Tissue biopsy tests can take up to 10 days to get a result leaving patients worried and missing out on treatment. However, with just a blood sample, this partnership could bring effective treatments to cancer patients in a shorter time.

Pleural mesothelioma, caused by exposure to airborne asbestos fibers, is an incurable cancer involving the lining of the lung. Nearly 3,000 Americans are diagnosed with mesothelioma each year. There is no cure for the cancer.

Mesothelioma Drug Given Promising Innovative Medicine Status in the UK

• Nancy Meredith
• Featured News, Research, Treatments

Boehringer Ingelheim has announced that the UK is following in the footsteps of the U.S. in the latest designation for the company’s drug nintedanib. In December 2016, the U.S. Food and Drug Administration granted orphan drug designation to the investigational cancer drug for the treatment of mesothelioma. Now, the UK Medicine and Healthcare Products Regulatory Agency has designated nintedanib a Promising Innovative Medicine for the treatment of malignant pleural mesothelioma.

The PIM designation, according to Gov.UK, is an indication that the product may be eligible for the early access to medicines scheme (EAMS) that brings medicines to patients with life threatening conditions when there is an unmet medical need. The designation was assigned based on the encouraging results of the phase II/III LUME-Meso trial, according to a Jan. 4 PharmaTimes article.

“This is fantastic news and the right decision taking into account the risk/benefit profile of nintedanib from a very credible Phase II trial,” said Professor Dean Fennell, Chair of Thoracic Medical Oncology at the University of Leicester and University Hospitals of Leicester NHS Trust, UK, commenting on the decision.

Results from the LUME-Meso Trial showed “statistically significant improvements,” according to Pharma Times, with mesothelioma patients treated with the drug plus chemotherapy achieving 9.4 months of progression free survival compared to 4.7 months for those patients receiving chemotherapy alone.

Nearly 2,500 cases of pleural mesothelioma are diagnosed each year in the UK. With limited effective treatment options the median survival is less than 14 months. Reports indicate that nearly 3,000 Americans are also diagnosed with the deadly cancer each year. New, effective treatments are critically important to improve mesothelioma patient survival.

To find out more about the LUME-Meso trial, see ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/results?term=%22malignant+mesothelioma%22&recr=Open&pg=1

Sources :

• U.S. Food and Drug Administration
  http://www.mercknewsroom.com/news-release/oncology-newsroom/merck-announces-fda-acceptance-review-mk-3475-biologics-license-appli
• Gov.UK
  https://www.gov.uk/government/news/medical-innovation-doctors-and-patients-encouraged-to-give-views
• PharmaTimes
  http://www.pharmatimes.com/news/pim_status_for_boehringers_mesothelioma_drug_1215220

Mesothelioma Patients Hopeful After Anti-Cancer Drug Alectinib Was “Superior” to Crizotinib for Some Lung Cancer Patients

• Nancy Meredith
• Mesothelioma, Treatments

In Dec. 2015 the U.S. Food and Drug Administration approved Alecensa (alectinib) for the treatment of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer in patients who have progressed on or are intolerant to Xalkori (crizotinib). Now, results from a global phase III clinical trial show alectinib, when used as a first-line treatment, “significantly reduced the risk of disease worsening or death compared to crizotinib in ALK-positive NSCLC patients.”

According to an April 10 press release from Roche, the maker of Alecensa, the ALEX study led the researchers to conclude, “Alecensa was superior as an initial treatment compared to crizotinib in this type [ALK-positive] of lung cancer.” In addition, patients did not experience any unexpected adverse side effects.

“Our goal is to transform the standard of care and we are excited to share these results with the lung cancer community”, said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. “As part of its Breakthrough Therapy Designation, we hope to bring Alecensa as an initial treatment for people with ALK-positive NSCLC as soon as possible and will discuss these data with global health authorities.”

Pfizer, the maker of Xalkori, reports that about three to five percent of people with NSCLC may test positive for ALK. There is a possibility that the marker is also present in certain pleural mesothelioma cases making Alecensa a treatment option for the disease. Lung cancer and pleural mesothelioma patients often undergo the same treatment protocol.

Alecensa is an oral medication that blocks the activity of the ALK protein, which may prevent cancer cells from growing and spreading. In the results, the team reports the “results showed that people treated with Alecensa lived significantly longer without their disease progressing compared to crizotinib when given as initial (first-line) treatment.”

Pleural mesothelioma is a rare form of lung cancer that invades the outer lining of the lungs called the mesothelium. The only known cause of mesothelioma is through inhalation or ingestion of airborne asbestos fibers.

Alecensa, with its target of patients with a specific biomarker, continues the progress towards personalized care that could benefit the nearly 3,000 patients in the U.S. diagnosed with mesothelioma each year. Medical care targeted to a patient’s unique characteristics and genetic makeup optimizes the potential for success of the treatment and offers treatment options that may not otherwise have been considered.

If you believe Alecensa could help you in your mesothelioma care, talk to your doctor, or visit Alecensa.com.

To find out more about the ALEX clinical trial see ClinicalTrials.gov.
https://clinicaltrials.gov/ct2/results?term=%22malignant+mesothelioma%22&recr=Open&pg=1

Sources

• (April 10 press release  from) Roche
  http://www.roche.com/media/store/releases/med-cor-2016-09-01.htm