Category: Featured News
Mesothelioma Community Eyes PD-L1 Inhibitor That Shows “Statistically Significant Survival” for Lung Cancer Patients
The mesothelioma community has been on cloud nine this year with clinical trials that have heralded good news across the globe. Immunotherapy treatments have moved into the spotlight, and it seems that instead of “if” the treatments become available to mesothelioma patients, it is “when.” Now, one more potential immunotherapy treatment for lung cancer and mesothelioma patients is on the horizon.
Genentech, a biotechnology company focused on developing treatments for patients with serious or life-threatening medical conditions, and a member of the Roche group, reported in a Sept. 26 press release that its investigational, anti-PDL1, immunotherapy drug atezolizumab (previously known as MPDL3280A), has seen positive results in two Phase II clinical trials for non-small cell lung cancer patients (NSCLC). Atezolizumab is designed to target PD-L1 expressed on tumor cells and tumor-infiltrating immune cells and to enable the activation of T cells, according to the company.
“Results from both of our studies in non-small cell lung cancer showed that measuring PD-L1 may help identify people most likely to respond to atezolizumab, and the majority of responses continued when these data were assessed,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development.
Atezolizumab, an inhibitor of cell programmed death ligand 1 (PDL1), has received breakthrough designation from the U.S. Food and Drug Administration for use in the treatment of NSCLC in patients whose tumors have high expression of PDL1 and whose disease worsened during or after standard treatments.
In October, the FDA approved Keytruda for advanced NSCLC. Keytruda, marketed by Merck, is also a PD-L1 inhibitor that has been shown to be effective in controlling mesothelioma tumors in three-fourths of patients. Mavis Nye of England, a six-year mesothelioma survivor, is virtually cancer free after over one year of Keytruda treatments during a clinical trial. (Keytruda is still known as MK-3475 in the UK.) And Lou Williams of Australia who has been battling mesothelioma for over 13 years was given new life when she began Keytruda.
Breakthrough Therapy designation from the FDA is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
The two atezolizumab studies are POPLAR, a clinical trial comparing the efficacy of atezolizumab with docetaxel chemotherapy, and the BIRCH study testing the efficacy of atezolizumab in PD-L1 positive patients.
The results of the studies were reported in Vienna, Austria at the European Cancer Congress 2015 held Sept. 25 – 29.
Genentech reports the results of the POPLAR study “showed a statistically significant survival benefit compared to chemotherapy” in patients with recurrent NSCLC with medium and high levels of PD-L1. The patients lived 7.7 months longer than those who received docetaxel chemotherapy.
The company reports that in the BIRCH trial, “atezolizumab shrank tumors (objective response rate, ORR) in up to 27 percent (p=0.0001) of people whose disease had progressed on prior medicines and also expressed the highest levels of PD-L1.”
“Higher PDL1 expression correlates with greater response rates and could be used to identify patient for treatment,” said lead author Benjamin Besse, MD, from the Gustave Roussy Institute, Villejuif, France, during the presentation.
For the nearly 3,000 Americans diagnosed with mesothelioma each year, every breakthrough is critical. Although the scientists are not promising a cure with the new drug, patients are hopeful the drug will bring an increased survival and a nearly uninterrupted lifestyle for the patients undergoing treatment.
- See the Sept. 27 MedScape article for more details on the results of the two trials.
- See NCT01903993 on ClinicalTrials.gov to find out more about the POPLAR clinical trial.
https://clinicaltrials.gov/ct2/show/study/NCT01903993?term=POPLAR&rank=1#locn
- See NCT02031458 on ClinicalTrials.gov to find out more about the BIRCH clinical trial.
https://clinicaltrials.gov/ct2/show/NCT02031458?term=BIRCH+MPDL3280A&rank=1
Sources:
- Atezolizumab
https://www.gene.com/media/press-releases/14607/2015-09-26/two-positive-studies-of-genentechs-inves - European Cancer Congress 2015
http://www.esmo.org/Conferences/Past-Conferences/European-Cancer-Congress-2015
Take the Time to Honor All Veterans
Today, our nation honors those who served our country.
November 11 is once again declared the Veterans Day holiday through a proclamation by the President of the United States.
“On Veterans Day, we reflect on the immeasurable burdens borne by so few in the name of so many, and we rededicate ourselves to supporting those who have worn America’s uniform and the families who stand alongside them.
On Veterans Day, and every day, let us show them the extraordinary gratitude they so rightly deserve, and let us recommit to pledging our full support for them in all they do.”
Unfortunately, to many of our veterans, the day signifies another day of fighting a debilitating injury or illness suffered during their service in the military. According to the latest U.S. Census Bureau data, there were 19.6 million military veterans in the U.S. in 2013. Of those, about 3.6 million now suffer from some form of disability. A small number of these veterans are suffering from mesothelioma or asbestosis, caused by years of exposure to asbestos during their military service.
Many veterans may be unaware that their time in the military may increase their risk of developing respiratory disease related to asbestos exposure. Inhaling microscopic asbestos fibers can lead to serious disease including asbestosis, a chronic scarring of the lungs; lung cancer and mesothelioma, a cancer of the lining of the lungs.
Approximately 3,000 Americans are diagnosed with mesothelioma each year. Statistics show that military veterans account for over one-third of those cases. Asbestos was used as insulation in military buildings and ships. It was also used as an insulator around heat and cooling systems, in Navy vessels and in the gaskets placed inside airplane engines and large machinery.
Take some time out of your day to visit a veteran and thank them for their service. You can also attend a parade or service to honor our veterans. Veteran’s Day celebrations are held throughout the U.S. To find a celebration near you visit the U.S. Department of Veterans Affairs website.
A Month of Advocacy, Education and Support for Mesothelioma Patients and Their Families
November is filled with opportunities for mesothelioma patients and their families to raise awareness of the disease, and to educate the American public of the issues facing the mesothelioma community. Not only is November Lung Cancer Awareness Month, but it is also National Hospice and Palliative Care Month and National Family Caregivers Month.
Those who live with pleural mesothelioma, and those who care for someone with mesothelioma, know that educating the public about the struggles facing rare disease sufferers often takes a focused effort from organizations, the government, the medical community and many volunteers. Join in with the organizations sponsoring the campaigns that are dedicated to promoting awareness, honoring those dealing with terminal cancers and to increasing support for the communities.
According to the Lung Cancer Alliance, lung cancer is the deadliest cancer in the world. In fact, more people die from lung cancer than breast, colon and pancreatic cancers combined. Over 158,000 Americans die from lung cancer each year – that is approximately 432 Americans every day. Pleural mesothelioma, a rare, aggressive form of lung cancer caused by past exposure to asbestos, is one of the most difficult cancers to treat and is diagnosed in close to 3,000 Americans each year.
Many mesothelioma patients are faced with treatments aimed at managing their symptoms and improving their quality of life as the tumors continue to spread and their health declines. Doctors often order palliative care which is intended to control pain, stop bleeding, relieve pressure, and to allow patients to be at home with their loved ones.
According to the National Hospice and Palliative Care Organization (NHPCO), “every year more than 1.6 to 1.7 million Americans living with life-limiting illness, and their families, received care from the nation’s hospice programs in communities throughout the United States.”
With an effort to encourage citizens to increase their understanding and awareness of care at the end of life, NHPCO has declared November National Hospice and Palliative Care Month. NHPCO encourages everyone to “celebrate all that the hospice and palliative care community has achieved.”
National Family Caregivers Month is also a time to recognize mesothelioma patients and their families. According to the Caregiver Action Network, more than 65 million family caregivers in this country fulfill a vital role on the care team. For mesothelioma patients, the caregivers are vital for helping them follow their medical, dietary and exercise regimens. Caregivers are called upon to deal with the myriad medical appointments, medical bills, updates to other family members and friends as well as ensuring that the household runs efficiently.
In this year’s presidential proclamation recognizing November as National Family Caregivers Month President Obama declared:
“For centuries, we have been driven by the belief that we all have certain obligations to one another. Every day, caregivers across our country answer this call and lift up the lives of loved ones who need additional support. During National Family Caregivers Month, let us honor their contributions and pledge to continue working toward a future where all caregivers know the same support and understanding they show for those they look after.”
This year, CAN is focusing on the theme “Respite: Care for Caregivers.” The organization reports that a respite for the caregiver is not a luxury, rather “the chance to take a breather, the opportunity to re-energize.” And, CAN reports, this is critical for the caregiver to protect his or her well-being.
To find out what you can do to help mesothelioma patients and their families during November visit these organizations’ websites: Caregiver Action Network, Lung Cancer Alliance, National Hospice and Palliative Care Organization.
Know more about Mesothelioma and how you can deal with it.
Sources
- Lung Cancer Alliance
http://www.kintera.org/faf/error/errorEvent.asp?err=c&ievent=347722&lis=1&kntae347722=B249B0A66E2742FDAC6A93B9B4BE2FD4 - National Hospice and Palliative Care Organization
http://www.nhpco.org/press-room/press-releases/national-hospice-and-palliative-care-month-proclamation - Caregiver Action Network
http://caregiveraction.org - President Obama
https://obamawhitehouse.archives.gov/the-press-office/2015/10/30/presidential-proclamation-national-family-caregivers-month-2015
Mesothelioma Community Celebrates FDA Approval of Keytruda for Lung Cancer Treatment
The mesothelioma community is hailing the recent U.S. Food and Drug Administration’s approval of Keytruda for advanced (metastatic) non-small cell lung cancer (NSCLC). A recent U.S. clinical trial found Keytruda to be effective in controlling mesothelioma tumors in three-fourths of patients, leading researchers to say the results are “encouraging.” The FDA’s approval moves the drug one step closer to U.S. mesothelioma patients.
In an Oct. 2 press release, the FDA announced approval of the immunotherapy drug from Merck, previously approved for use in the treatment of melanoma, for use in the treatment of NSCLC in patients whose disease has progressed after other treatments and with tumors that express a protein called PD-L1. A companion diagnostic test will be used to detect the PD-L1 biomarker in patients.
“Today’s approval of Keytruda is the result of our deep commitment to bring the benefits of immunotherapy to cancer patients,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories, in Merck’s Oct. 2 press release announcing the approval. “Together with scientists and physicians around the world, we endeavor to improve the lives of patients suffering from these grievous illnesses.”
Keytruda works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Keytruda may help the body’s immune system fight the cancer cells.
Like lung cancer, pleural mesothelioma is an aggressive cancer that is challenging to treat. Pleural mesothelioma is an insidious cancer that lurks in the body for decades until symptoms suddenly appear leaving the patient with life-threatening complications. The asbestos-caused cancer affects the lining of the lungs and often leaves patients with less than 18 months to live after diagnosis.
According to one study from Spanish researchers, PD-L1 is expressed in approximately 20 percent of pleural mesothelioma patients. The researchers reported, “The results of our study could offer new treatment to this population of patients, identifying a subset of malignant pleural mesothelioma who expressed PD-L1 and could be treated with targeted therapies to PD-L1.”
Mavis Nye, a six-year mesothelioma survivor, of England, has been a patient for over a year in a Phase I, no placebo clinical trial for Keytruda, still known as MK-3475 in the UK. Mavis says she has seen “brilliant” results with the drug. Mavis told MesotheliomaHelp that she has nearly complete tumor shrinkage, and “I’m feeling very well as my immune system has been turned back on by the drug.”
Lou Williams of Australia, a 13 year mesothelioma survivor, has received eight treatments of Keytruda, and will continue on it indefinitely. She told MesotheliomaHelp, “Keytruda has given me back my life, as my body was literally shutting down. I am now once again living my life with quality, strength and determination.”
Others in the mesothelioma community are hoping for the same results, and Lou and Mavis have both been tireless advocates in trying to bring the drug to others in their respective countries. While Mavis pushes for broader clinical trial participation, Lou pushes for reduced costs for the drug in her home country.
Hopefully, the time has arrived for an effective treatment for mesothelioma and lung cancer across the globe.
“Our growing understanding of underlying molecular pathways and how our immune system interacts with cancer is leading to important advances in medicine,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in the FDA press release. “Today’s approval of Keytruda gives physicians the ability to target specific patients who may be most likely to benefit from this drug.”
Talk to your oncologist to see if Keytruda can be an effective treatment for you.
Sources:
- Oct. 2 press release (FDA announced approval of the immunotherapy)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm465444.htm - Merck’s Oct. 2 press release
http://www.mercknewsroom.com/news-release/prescription-medicine-news/fda-approves-keytruda-pembrolizumab-treatment-patients-metas - Spanish researchers
http://www.esmo.org/Conferences/Past-Conferences/ESMO-2014-Congress/Press-Media/Studies-Report-New-Findings-on-Treatment-Options-for-Mesothelioma
Paddling the Hudson River to Raise Awareness and Funds for Mesothelioma
Attorney Joseph W. Belluck of the New York law firm of Belluck & Fox, and his son, William, took to the Hudson River and kayaked in the Kayaking4Meso event, held September 12 in Stillwater, NY. The event, in its fifth year, is held to raise awareness, and funds, in the fight against mesothelioma, an aggressive cancer caused by asbestos exposure. Belluck & Fox, LLP has sponsored the event, planned in conjunction with National Mesothelioma Awareness Day held Sept. 26, every year.
“Belluck & Fox, LLP has been a sponsor of the event since its inception and we are proud to be able to help raise money for mesothelioma research,” said Belluck. “There are several other law firms who sponsor the event but we are the only firm that also shows up to kayak.”
The event grew out of a father’s love of his daughter who was diagnosed with peritoneal mesothelioma as a teenager and was given just twelve months to live. Mark Wells, whose daughter, Linda, was diagnosed with peritoneal mesothelioma at age 16, organizes the annual Kayaking4Meso event to raise awareness and Money for Mesothelioma Research.
“Linda is my inspiration for doing what I do,” said Wells in an email to Mesothelioma Help. “Realizing there was no cure, I figured the next best thing to do was to raise awareness and money for research.”
Expert Insight
Mark Wells, Kayaking4Meso Organizer
“Don’t ever give up hope. Research is going on every day and new trials are available often. I will continue to raise awareness and money for research.”
Peritoneal mesothelioma is a form of cancer that is almost always caused by asbestos exposure and affects the lining of the abdomen. While there are close to 3,000 cases of all forms of mesothelioma diagnosed in the U.S. each year, less than 10% of those are peritoneal. The cancer, which is often associated with former industrial workers who were exposed to asbestos decades ago, is virtually unheard of among young adults.
Linda is the youngest person Wells knows who has been diagnosed with mesothelioma. She has battled the disease for “almost half her life and is now one of the longest survivors I know,” said Wells. Linda has lived with the disease for 13 years.
“She is doing as well as can be expected for what she’s been thru,” Wells added.
Raising Money to Find a Mesothelioma Cure
In 2011, Mark Wells and two friends paddled from Schuylerville to Mechanicville. The trio kayaked about 16 miles through locks 4 and 3. Five years later, over 150 boaters lined up to kayak down the Hudson River from Admiral’s Marina in Stillwater thru Mechanicville, ending at Lighthouse Park in Halfmoon. The eight mile paddle took the group thru Locks 4, 3 and 2 during the 3.5 hour excursion.
“This year was especially rewarding to see over 150 kayakers come out to attend and support our cause, including Joe Belluck himself,” Wells said. “Our biggest event ever and Joe has been a part of it every year. I think his commitment to help us from the beginning inspired me into making this a successful event,” said Wells. “It’s made a huge difference to me and the success of our event.”
Expert Insight
“This is symbolic of what makes our law firm different from the other lawyers that represent people with mesothelioma – whether it’s participating in an event like this or representing one of our clients – we fully commit our time and energy.”
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The money raised during the event goes to the Mesothelioma Applied Research Foundation. The organization is the only non-profit organization dedicated to ending mesothelioma and the suffering caused by it, according to the Meso Foundation’s website.
Wells said the Meso Foundation has helped his and many other families with knowledge and advocacy by directing them to doctors, hospitals, and clinical trials.
Wells said the events have raised more than $40,000 to date to aid in research to find a cure.
“I think the thing that impacts me most is the meso family that we have created with this event, with six meso survivors attending and over 30 family members,” said Wells. “I think it means a lot to all us to get together to support each other.”
Asbestos Along the Hudson River
Belluck, a mesothelioma lawyer who has been advocating for mesothelioma patients and their families for over 15 years, finds the irony in the event organized to raise money to fight an asbestos-caused disease. He fights for compensation for victims of asbestos-related diseases, he says, and the route took the paddlers through three of the Champlain Canal Locks that allowed so many of the companies that the firm’s clients worked at to prosper.
“This stretch of the Hudson north of Albany is beautiful, the leaves have begun to turn and it’s a gorgeous fall day,” Belluck said of last Saturday’s event. “But, we also paddled past some of the factories where our clients worked, and one area of the Hudson where the soil is being dredged and renewed from the toxic substances that not only injured our clients but also poisoned this beautiful river. And perhaps that is a good metaphor for why we do this work.”
Mesothelioma is an asbestos-related cancer that is usually diagnosed in older men – after spending years as trade workers such as insulators, plumbers and pipefitters, electricians and sheet metal workers. With an extended incubation period, it is often not diagnosed for decades after asbestos exposure. Approximately 2,500 to 3,000 people in the United States are diagnosed with mesothelioma each year.
Sources :
- Kayaking4Meso
http://www.kayaking4meso.org - Meso Foundation’s website
http://www.curemeso.org/site/c.duIWJfNQKiL8G/b.8578185/k.6D0E/Meso_Foundation_Symposium.htm
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