2015 Year in Review: Top Mesothelioma Stories

Another year is coming to a close, but for those in the mesothelioma community it is the end of another year without a cure. Unfortunately, once again, Mesothelioma Help lost a “Faces of Mesothelioma” friend to mesothelioma during the year. David Stetler, whose daughter Amanda chronicled his ups and downs during his battle with the disease, passed away on March 16 leaving many wondering if this needless suffering will ever end.

But, there has been some good news from researchers and the medical community. While they may not have brought an end to the asbestos cancer, there are many treatments in clinical trials, promising leads still in the lab, and several approved treatments now available to patients that show promise for effectively fighting back the relentless cancer.

Every year Mesothelioma Help reports on the top mesothelioma stories of the year, and below we highlight some of our most important stories of 2015.

Number One MesotheliomaHelp Story of 2015

Once again, Mavis Nye of England, who has been living with mesothelioma for six years, and has been a staunch advocate for herself and for all mesothelioma patients, takes the top spot for successfully fighting mesothelioma in 2015.

In 2014, Mavis enrolled in the MK-3475 clinical trial being run at The Royal Marsden, a world-leading cancer center in the UK. MK-3475 is known as Keytruda in the U.S. where it has been approved for the treatment of advanced lung cancer and melanoma.

Mavis was one of the first mesothelioma patients in the UK to participate in the trial designed to test the efficacy of the drug, developed by Merck, in suppressing the PD-L1 biomarker found in cancer cells. PD-L1, or programmed death-ligand 1, is a protein that has been shown to play a role in suppressing the immune system during cancer and other diseases.

Mavis announced in her Nov. 17 blog that her doctors told her during the reading of her scan results that she no longer has any active mesothelioma in her tumors. December 16 marked her 40th treatment with MK-3475. She will continue on the drug through the end of the trial, May 2016.

Patients across the U.S. are clamoring for Keytruda after 91-year-old, former president Jimmy Carter announced in December the drug helped him beat melanoma, that had metastasized to his liver and brain.

We hope all mesothelioma patients see the same results as Mavis!

PD-L1 Inhibitors in the Spotlight. In addition to Keytruda, the number one success story of 2015, various other PD-L1 inhibitors have also seen success in fighting back cancers.

Opdivo: Opdivo, developed by Bristol-Myers Squibb, is another FDA-approved lung cancer drug that works by blocking the PD-L1 protein and activating the immune system. Except for the dosing differences, Opdivo and Keytruda are comparable, according to reports.

“This is yet another example of the advances we are making in the treatment of lung cancer using the approach of targeting specific tumor genes and their mutations.”

Genentech: The company reports 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). The results “showed a statistically significant survival benefit compared to chemotherapy” in patients with recurrent NSCLC with medium and high levels of PD-L1.

FDA Approvals. The U.S. Food and Drug Administration has been on a roll this year in approving anti-cancer drugs. While none of the approvals are specific to mesothelioma, those approved for lung cancer care open new doors for treatment of mesothelioma patients.

The FDA announced last month that it has approved Portrazza (necitumumab) to be administered in combination with the chemotherapy drugs gemcitabine and cisplatin to treat patients with advanced squamous non-small cell lung cancer who have not previously received cancer treatment. The approval, represents progress for patients diagnosed with metastatic squamous non-small cell lung cancer, as each new therapy advances cancer care and gives patients hope for improved outcomes.”
The FDA granted accelerated approval for the anti-cancer drug Tagrisso (osimertinib) to treat patients with advanced NSCLC. According to AstraZeneca, the maker of Tagrisso, also known as AZD9291, the drug is targeted to patients whose tumors express the EGFR mutation (T790M) and whose disease has gotten worse after treatment with other EGFR-blocking therapy. Tagrisso is the only approved medicine indicated for NSCLC patients with the EGFR T790M mutation. Researchers have found that over 50% of pleural mesothelioma patients express the EGFR protein.
On Dec. 11, the FDA announced approval of Alecensa (alectinib) for the treatment of ALK-positive NSCLC in patients who have progressed on or are intolerant to Xalkori (crizotinib). Alecensa, from Genentech, is an oral medication that blocks the activity of the ALK protein, which may prevent cancer cells from growing and spreading.

Immunotherapy. With Keytruda leading the news, developments in the field of immunotherapy for the treatment of mesothelioma have made this year particularly newsworthy.

“Immunotherapy is a new class of cancer treatment that works to harness the innate powers of the immune system to fight cancer,” according to the Cancer Research Institute. Recharging the body’s own defense mechanism, the immune system, immunotherapy therapies may hold greater potential than current treatment approaches:

To fight cancer more powerfully,
To offer longer-term protection against the disease,
To come with fewer side effects, and,
To benefit more patients with more cancer types.

MesotheliomaHelp will continue to bring articles focused on immunotherapy to our readers.

(Note: According to medical reports, immunotherapy drugs like Keytruda and Opdivo help a minority of patients, but those who respond to the treatment often do extremely well.)

COMMAND Trial Stops Enrollment. Last year the COMMAND (Control Of Mesothelioma with MAiNtenance Defactinib) trial was seen as one of the bright spots in the future of mesothelioma treatment. Sadly, this year, the clinical trial was halted after a data safety monitoring board found that VS-6063, when given to mesothelioma patients as part of the COMMAND (Control Of Mesothelioma with MAiNtenance Defactinib) trial, did not produce “a sufficient level of efficacy” to justify continuation.

About Mesothelioma

Mesothelioma is a deadly cancer of the lungs, heart or abdomen, caused by past exposure to asbestos. Mesothelioma has a long latency period where those exposed to asbestos may not exhibit symptoms for nearly 60 years after exposure. Mesothelioma can be treated with surgery, chemotherapy and radiation, however, the likelihood of recurrence of the cancer is high. There is no cure for mesothelioma.

Know more about Mesothelioma and how you can deal with it.

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

Navy Veteran Asbestos Exposure - Mesothelioma

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.

Your Presence is the Perfect Present For Mesothelioma Patients

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

Category: Featured News