Mesothelioma Help Cancer News
First-Ever FDA Approval of Anti-Cancer Drug Based on Biomarker and Not Cancer Type Is Encouraging for Mesothelioma Patients
Last week MesotheliomaHelp reported on the drive towards using DNA sequencing on cancer patients in an effort to determine the appropriate treatment based on the patients’ biomarkers. Keytruda, that targets the PD-L1 marker, was cited as an example in that article. Now, the U.S. Food and Drug Administration has granted accelerated approval to Keytruda as a treatment based solely on the genetic mutations of a cancer and not on the type of cancer.
The FDA announced in a May 23 press release, that this is the first-ever approval of a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated. Keytruda has already been approved for in the U.S. for use in melanoma and lung cancer patients after a prior round of chemotherapy failed to stop progression of the disease. This approval is for unresectable or metastatic solid tumors, of any type, that have been identified as having a biomarker referred to as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
Expert Insight
Richard Pazdur, M.D., FDA
“This is an important first for the cancer community.”
“Until now, the FDA has approved cancer treatments based on where in the body the cancer started—for example, lung or breast cancers,” said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. “We have now approved a drug based on a tumor’s biomarker without regard to the tumor’s original location.”
This approval, according to the FDA, was based on the results of five clinical trials for patients with MSI-H or dMMR solid tumors. The patients had a variety of cancers, including colorectal and endometrial. Of the 149 patients who received Keytruda in the trials, nearly 40 percent had a complete or partial response, with 78 percent of those patients seeing a lasting response for six months or longer.
“The FDA’s approval of this first-of-its-kind, tumor-agnostic, indication is further evidence of Merck’s commitment to helping people with difficult-to-treat cancers, and to advancing the use of biomarkers to guide clinical decision-making,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories, in a May 25 press release announcing the approval.
This approval has far-reaching implications for the mesothelioma community for future approvals of biomarker-driven drugs. Significant research has been conducted to find those biomarkers that drive the uncontrollable growth of mesothelioma, and other cancers, and this landmark approval moves oncologists much closer to offering personalized care. Targeted therapy improves quality of life and increases survival for cancer patients.
“This approval for Keytruda is a transformational milestone in our progress toward personalized immunotherapy, offering certain patients with difficult-to-treat cancers a medicine based on the genetic makeup of the tumor – regardless of tumor type,” said Dr. Luis A. Diaz, Jr., head of the Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center.
Mesothelioma is an asbestos-caused cancer with a prognosis often less than 18-months. New, effective treatment options are critically important to allow patients to live longer lives.
Patients should talk to their oncologists to determine whether Keytruda is a treatment option for them. Visit the Keytruda website to find out more about the drug.
Sources:
- FDA
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm560167.htm - Merck Research Laboratories
http://www.mrknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-keytruda-pembrolizumab-adult-and-pediatr - Keytruda website
https://www.keytruda.com/?cc=F56EF8DC&csid=General_Brand_Lung&gclid=CjwKEAjw4IjKBRDr6p752cCUm3kSJAC-eqRtAmMqxwdRx6gjIkSciP4aQ8fZl3M5fzF-2jLSDG5kmhoCzVbw_wcB
Daughter & Father Keep Hope Alive During Fight Against Mesothelioma
Some individuals are just positive people; it’s how they are! No matter what is thrown at them or what comes their way, they have the ability to make the best of things. This, in turn, helps those around them to be optimistic, too.
My Dad was one of those people. Many individuals ask me how my family stayed so upbeat (for the most part) during our experience with mesothelioma. The simple answer was, “Dad.” When the person who has been diagnosed with this disease is the one reassuring everyone else that things will be ok, it’s hard to believe otherwise. This is not to say that I didn’t have my moments, but there was more light in my days than I expected during this time.
Some may think that I was naïve to think this way, but it was how I chose to handle it. I believe that attitude can have a direct effect on outcome, so why not think the best! Even on the days when I felt the most sadness and anxiety about Dad’s illness, he would always tell me that he would be ok. God would take care of him and all of us as well.
Going through life thinking the worst must be exhausting. Life is a challenge, bringing with it ups and downs that you may never be prepared for. But we are also meant to make the best of what we are given. Dad inspired me to always look for the best in every situation and it has truly changed my entire outlook on the world. There is inherent good in people, there is hope when all seems dark, and there is love where you couldn’t imagine it could ever be found. Never give up hope, God will always be there!
Targeted Therapy May Soon be Primary Approach for Mesothelioma Treatment
Targeted care optimizes the potential for success of mesothelioma treatment and provides the patient with the assurance that his cancer is being treated according to his unique characteristics. Personalized cancer treatment is gaining popularity among physicians and oncologists, however, it is far from mainstream. If researchers from University of Michigan have their way, however, treatment for all cancers will soon be personalized based on the patient’s biomarkers.
In a new study released from researchers at the University of Michigan Comprehensive Cancer Center, the team looked at the DNA sequencing of nearly 500 patients. Of those, almost 75 percent of them had biomarkers that can be targeted by either existing or experimental anti-cancer treatments.
Biomarkers, including EGFR and PD-L1, that are present in mesothelioma and other cancers, help indicate the reason for the growth of the cancers and are the focus of current and experimental treatments used to fight the deadly disease. Many clinical trials are being offered now for mesothelioma patients that pinpoint particular biomarkers. One well-known trial is the Keynote-28 trial, that eight-year mesothelioma survivor Mavis Nye of England participated in, that targeted the PD-L1 marker and put her mesothelioma in remission.
“Availability of biomarker trials is crucial for being able to act on these results,” says Erin Cobain, M.D., clinical lecturer of hematology/oncology at the University of Michigan Medical School.
The value of the study lies in the method used to sequence the genes and the process for developing patient care based on the results of the sequencing. Using “next generation sequencing” the team reports that the genetic sequencing looks at all of the DNA and RNA expressed within a tumor, as well as sequencing the patient’s normal genome to identify genes that may be inherited from the patient’s parents.
Expert Insight
Erin Cobain, M.D., University of Michigan
Sequencing is beginning to have a real impact on treatment recommendations.”
Using MI-ONCOSEQ, the tool developed at the Michigan Oncology Sequencing Center, the test uses a fresh biopsy from the patient, as opposed to frozen tissue samples used by commercially-available tools, allowing the Michigan researchers to perform a more comprehensive analysis. According to the press release, commercial tests analyze only about 350 genes compared to MI-ONCOSEQ’s ability to cover at least 1,700 genes.
Mesothelioma is an incurable, asbestos-caused cancer of the membranes that surround many of the body’s vital organs, including the lungs. The cancer is highly aggressive and is resistant to many cancer treatments making it a difficult disease to treat effectively. Thus, developing a treatment protocol that specifically targets the genetic makeup of the patient’s cancer is vital for improving survival rates.
Nurse Explains Cancer Staging
Staging of a person’s cancer is done for many different reasons. According to the American Cancer Society, staging is defined as: “The process of finding out how much cancer is in the person’s body and where it is located. It’s how the doctor determines the stage of a person’s cancer.” For mesothelioma, there have been various different staging systems put in place over the years at different institutions. This sometimes leads to confusion regarding the language, a patient’s prognosis, and for scientists hoping to speak a common language when collaborating.
Most cancers are staged using the TNM classification system. T stands for the primary tumor, N stands for the lymph nodes- whether the cancer has spread to nearby lymph nodes, M stands for metastasis, whether the cancer has spread to distant parts of the body. Each of these three classifications- T, N, M – is then broken down with more descriptive information. Once the extent of the T, N, M classifications have been determined, they are then assigned an overall stage. There are also other factors that affect the stage, including the grade- how the cells look under the microscope, cell type, location, and tumor marker levels. Once cancer is staged it always remains the same. If you are diagnosed with Stage 2 cancer, it will always be referred to as Stage 2 even if it goes into remission, or metastasizes to other organs.
For many years, mesothelioma experts did not have a defined staging system exclusively to describe mesothelioma. A mesothelioma expert once said mesothelioma is so rare just having the diagnosis of mesothelioma, at an earlier point in time, would have gotten you into a mesothelioma clinical trial.
As testimony to progress, a group led by Dr. Valerie Rusch of the Memorial Sloan Kettering Cancer Center, in conjunction with the International Mesothelioma Interest Group, and other organizations has defined a new staging system for pleural mesothelioma. The importance of mesothelioma staging system is uniformity in describing the disease. The effect of various treatment options can be studied and perfected for the different types of pleural mesothelioma.
More evidence that the treatment of mesothelioma is being advanced on many fronts and further work towards a potential cure!
If you have questions about your mesothelioma treatment or any aspect of your mesothelioma care, please email me at [email protected].
Writing About Mesothelioma & Family’s Journey
People often ask me, “Why do you keep writing and working for a cure for mesothelioma, even though your Dad is no longer here?” Continuing to work for and with the mesothelioma community is not even a question for me. I do it because it matters.
My Dad is no longer with us, it’s true, but the memories he left me and the impact he had on my life are still vibrant. I do this so that his struggle will not have been in vain. He meant something to so many people, and I want his story to inspire others to not give up and have strong faith in God.
I write because I hope that my family’s journey can bring comfort to someone in need. I hope that if there is a person struggling or looking for an answer, they can find some respite in what we went through. Sure, we went through a hard time, but maybe we can help somebody from going through the troubles that we did.
I work because mesothelioma is already an orphan disease. Why should I orphan it as well? It is because people don’t talk about it that this cancer has become so little-known. They say that knowledge is power. I want to bring about as much awareness as I can to highlight the dangers of asbestos and to work to prevent one more person from suffering from this disease.
It matters. This cause, so close to my heart, that took my beloved father from me, matters. You matter. Your loved one matters. Your story matters. Never forget that, and never stop fighting.
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