Month: January 2017
FDA Grants Orphan Designation to Investigational Mesothelioma Drug
Boehringer Ingelheim announced in December that the U.S. Food and Drug Administration has granted orphan drug designation to its investigational cancer drug nintedanib for the treatment of mesothelioma.
Malignant pleural mesothelioma, a rare cancer caused by exposure to asbestos, is one of the nearly 7,000 diseases designated as rare, or “orphan,” in the United States. An orphan disease status is assigned to a disease or disorder if it affects fewer than 200,000 Americans at any given time. Mesothelioma is diagnosed in close to 3,000 Americans each year, and nearly the same number die from the asbestos-caused disease. There is no cure for the cancer.
The FDA notes that the Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders, or that affect more than 200,000 persons but the companies are not expected to recover the costs of developing and marketing a treatment drug.
According to Boehringer Ingelheim, the maker of nintedanib, also known as BIBF 1120, the drug is an oral triple angiokinase inhibitor which simultaneously inhibits vascular endothelial growth factor receptors (VEGFR 1-3), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR 1-3) signaling pathways. These three different angiokinase receptors play an important role in blood vessel formation and in tumor growth and metastases.
Nintedanib “has shown promise as a potential treatment for malignant pleural mesothelioma in clinical trials to-date, and this designation is a validating milestone in its development,” said Martina Flammer, M.D., Vice President, Clinical Development & Medical Affairs Specialty Care, Boehringer Ingelheim in a Dec. 14 press release from Boehringer Ingelheim. “We are proud to receive this designation for nintedanib from the FDA, resulting from our ongoing commitment to researching potential treatment options for rare cancers such as mesothelioma.”
The FDA granted designation based on the positive results from the ongoing Phase II/III LUME-Meso trial. Boehringer reports LUME-Meso is an international trial evaluating the efficacy and safety profile of nintedanib plus chemotherapy (pemetrexed/cisplatin) followed by nintedanib, versus placebo plus chemotherapy (pemetrexed/cisplatin) followed by placebo, in patients with unresectable malignant pleural mesothelioma.
“We are very encouraged by these recent data; the [clinical trial] results have led to an extension of the study into a Phase III confirmatory trial that is now underway and will provide further insight into the potential of nintedanib for patients with MPM [malignant pleural mesothelioma],” said lead investigator, Professor Giorgio V. Scagliotti, University of Torino, Chair of the Department of Oncology, Italy, at the 17th IASLC World Conference on Lung Cancer in Vienna.
Patients are currently being recruited worldwide for the trial. To find out more, see ClinicalTrials.gov.
Sources:
- ClinicalTrials.gov
https://clinicaltrials.gov/ct2/results?term=%22malignant+mesothelioma%22&recr=Open&pg=1 - Boehringer Ingelheim
https://www.boehringer-ingelheim.us/press-release/nintedanib-granted-orphan-drug-designation-treatment-mesothelioma - 17th IASLC World Conference on Lung Cancer
https://www.boehringer-ingelheim.us/press-release/clinically-meaningful-data-oral-nintedanib-mesothelioma-presented-world-conference
Victim’s Daughter Answers Question, “What Is Mesothelioma?”
“But what is mesothelioma?” This question usually follows when I tell people how my Dad passed away or why I’m fundraising. I then go into what causes it, the treatments Dad went through… the “science” of the disease. Most of the time, people nod their heads and go on with their day. But they don’t know the part about what mesothelioma really is to those who live it.
Mesothelioma is a thief, I’ve said this before. It steals your loved ones, their quality of life, and their comfort. In the last five years, I have seen so many people lose parents, spouses, and friends from this cancer. I, myself, have lost people that I care about to mesothelioma that I have gotten to know through being a part of this community.
Mesothelioma is a way of life. Unfortunately, when you are struck with this diagnosis, it consumes every part of you. Patients are constantly seeing doctors, receiving treatment, and thinking about the fact that they have mesothelioma. Caregivers are always looking for ways to help their loved one. And the truth of the matter is, for me, those three months between Dad’s scans were always torturous. You never knew what would be around the next corner. It truly takes precedence over every other aspect of your life.
Mesothelioma is unforgiving, unapologetic, and does not discriminate. I have known very young people and the elderly who have been stricken with this cancer. It doesn’t care who you are or what you do. It can’t be bothered by the fact that you have a family who you love and who needs you. It simply takes.
Mesothelioma is, in fact, a cancer caused by exposure to asbestos, but it is so much more. This disease has changed my life and the lives of countless others in ways that we never could have imagined.
UK Researchers Identify Gene That May Limit Metastasis in Mesothelioma
Previous studies report that metastasis is the cause of nearly 90 percent of cancer deaths, but it remains poorly understood. Once cells mutate and spread to distant regions of the body the cancer becomes difficult, and in the case of pleural mesothelioma, impossible, to eradicate. Getting a handle on the spread of cancer is critical for increasing survival. Now, researchers report they have found a gene that can reduce metastasis by three-fourths.
Using mice models, researchers from the Wellcome Trust Sanger Institute of the UK identified 23 genes that either increased or decreased the spread of cancer cells to the lungs. They also found that these genes impacted the immune system, the body’s natural defense mechanism for fighting cancer. They homed in on the Spns2 gene and found that when the gene was removed, the largest change occurred resulting in a reduction of nearly four times in the spread of tumors to the lungs. The researchers reported that the effect of this gene on colon, lung and breast cancers also resulted in reduced metastasis.
“Loss of the Spns2 gene causes the greatest reduction in the formation of tumour colonies and represents a novel therapeutic target,” said Dr. David Adams from the Wellcome Trust Sanger Institute, in a Jan. 11 press release. “Drugs that target this could help reduce or prevent the spread of tumours through the body.”
Stopping tumor growth and preventing metastasis is especially critical for increasing survival in mesothelioma and lung cancer patients. Mesothelioma is one of the most aggressive cancers, and one of the reasons is due to the ability of asbestos fibers to become embedded in the lining of the lungs and to fester for years, even decades, before any symptoms develop. Once mesothelioma is diagnosed, it is typically in an advanced stage where treatment is moot.
This research, however, led the researchers to better understand the Spns2 gene’s impact on the immune system and in tumor spread. This combination brings hope to many in the cancer community that an effective treatment could deliver a one-two punch by waking up the immune system and halting metastasis.
Expert Insight
Dr Justine Alford, Cancer Research UK
“Cancer that has spread is tough to treat, so research such as this is vital in the search for ways to tackle this process.”
These findings suggest another unique cancer characteristic to be considered when personalizing care for lung cancer and mesothelioma patients. Targeted therapy improves the prognosis in people suffering from mesothelioma and other cancers.
“This work supports the emerging area of immunotherapy, where the bodies’ own immune system is harnessed to fight cancer,” said Dr. Anneliese Speak of the Sanger Institute. “Investigation of further targets in the Spns2 pathway, or other targets identified in this study could help develop potential therapies.”
2017 Calendar Mesothelioma Events
As progress continues to be made in the fight against mesothelioma, 2017 looks promising in continuing the march to a cure. For patients and families looking for more information on the latest developments, there are plenty of conferences to offer knowledge, along with support.
The Mesothelioma Applied Research Foundation is holding its International Symposium on Malignant Mesothelioma March 27 -March 29. The event will be co-hosted by the National Cancer Institute in Bethesda, Maryland.
The 13th Annual International Asbestos Awareness and Prevention Conference, sponsored by the Asbestos Disease Awareness Organization, is April 7-9 in Arlington, Virginia.
Following are other days and events held throughout the year that are intended to help bring attention to mesothelioma, and cancer in general.
- February 2, 2017- National Cancer Prevention Day
- February 28,2017- Rare Disease Day (NORD)
- May 20,2017- International Clinical Trials Day ICTD
- June 5,2017- 29th Annual National Cancer Survivors Day
- August 1, 2017- World Lung Cancer Day
- September 26,2017- Mesothelioma Awareness Day
You can also find caregiver recognition events and online support groups for both patients and families. For some it is impossible to get to these events, but it is possible to participate online. If you know of any, and would like the rest of the mesothelioma community to be aware of, please let us know.
Everyone is different, as is everyone’s journey with mesothelioma. Some people like to find out as much as they can about the disease, some go to events to enjoy the sense of community. Whatever your personal situation- support is available.
If you have questions about your mesothelioma treatment or any aspect of your mesothelioma care, please email me at [email protected].
Sources:
- Mesothelioma Applied Research Foundation
http://www.curemeso.org/site/c.duIWJfNQKiL8G/b.8598593/k.D685/Homepage.htm - Asbestos Disease Awareness Organization
http://www.cvent.com/events/2012-annual-asbestos-awareness-conference/archived-e6277e3d443b4c059bed43fc0937b530.aspx - 13th Annual International Asbestos Awareness and Prevention Conference
http://www.asbestosdiseaseawareness.org/archives/40117
Older Patients Burdened by Mesothelioma and Lung Cancer Treatments
The American Cancer Society reports that lung cancer mainly occurs in older people, with about two out of three lung cancer patients aged 65 or older. The average age at the time of diagnosis is about 70. Pleural mesothelioma, a cancer caused by exposure to asbestos, produces tumors that grow uncontrollably in the lining of the lung and is equally as aggressive and difficult to treat as lung cancer. About three out of four people with mesothelioma are older than 65 years. Now, researchers report that these older patients “face a significant treatment burden” when diagnosed with cancer.
According to a Jan. 10 article in Medical News Today, this older population of patients may face spending one-third of their time interacting with medical teams for the 60 days following surgery or radiation. Previous research has shown that nearly half of older cancer patients have medical problems that also need to be addressed such as reduced physical functioning, nutritional deficiencies, fatigue and depression. Pointing to all of these issues, researchers from Yale found after treatment for cancer, older patients saw an average of 20 different physicians and took 12 different medications.
“To our knowledge, this is the first study to characterize treatment burden for early-stage lung cancer patients in terms of touches with the healthcare system, including emergency department visits, hospital-based follow-up care, number of physicians, and outpatient visits,” said first author Carolyn Presley, M.D., instructor at Yale Cancer Center and a Robert Wood Johnson Clinical Scholar at Yale School of Medicine.
This news may come as no surprise to many in the mesothelioma community who have battled pleural mesothelioma themselves or who stood by their loved one as they underwent treatment. Battling any disease for the older population is difficult, but dealing with a painful, incurable cancer can be extremely challenging. Treatment for mesothelioma is often a complex regimen including surgery, chemotherapy and radiation. These treatments also come with a set of side effects that can lead to more medical challenges in an older patient.
“These findings highlight a need to improve cancer care coordination. It’s also a call for providers to think about the burden we might be placing on patients,” said Carolyn Presley, M.D.
While the average survival time of mesothelioma patients typically varies from 4 – 18 months after diagnosis, many factors determine the life expectancy. Factors include type and stage of mesothelioma, treatment plan, whether the patient has ever smoked, the lifestyle, diet and fitness level of the patient, as well as age, sex and family traits.
Read the full study in the January issue of Journal of Oncology Practice.
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