Month: April 2017
Accelerated Approval Granted to Drug in Mesothelioma Research Pipeline
In July, MesotheliomaHelp reported on a phase I clinical trial where various cancers, including mesothelioma, were being tested for the safety and tolerability of the drug avelumab. Now, the maker of the drug reports the U.S. Food and Drug Administration has granted accelerated approval to Bavencio (avelumab) for the treatment of patients with metastatic Merkel cell carcinoma (MCC).
EMD Serono Inc. reports the approval was based on the results of the JAVELIN clinical trial where of 88 patients with MCC who had been previously treated with at least one chemotherapy regimen, 33 percent experienced complete or partial shrinkage of their tumors. The response lasted for more than six months in 86 percent of responding patients and more than 12 months in 45 percent of responding patients, according to the FDA.
“The scientific community continues to make advances targeting the body’s immune system mechanisms for the treatment of various types of cancer,” Richard Pazdur, MD, of the FDA office of hematology and oncology products, said in a March 23 press release. “These advancements are leading to new therapies — even in rare forms of cancer where treatment options are limited or non-existent.”
Bavencio is an investigational immunotherapy drug that targets the PD-L1 protein. The drug works by blocking signals from PD-L1 tumors, activating the immune system, allowing it to take over and attack and kill cancer cells. Merck KGaA, Darmstadt, Germany, and Pfizer have formed a strategic alliance to co-develop and co-commercialize the drug. This is the first FDA-approved therapy for patients with MCC.
Metastatic MCC is a rare and aggressive skin cancer, with fewer than half of patients surviving more than one year and fewer than 20% surviving beyond five years.
Like MCC, mesothelioma is a rare, orphan disease that is challenging to treat and often recurs in patients. Prognosis for mesothelioma is often less than 18 months. With an initial positive result for mesothelioma patients with this drug in the JAVELIN clinical trial, the mesothelioma community is hoping for continued positive results that could lead to a new treatment for patients with the asbestos-caused cancer.
According to the FDA, Accelerated Approval enables the FDA to approve drugs for serious conditions to fill an unmet medical need using clinical trial data that is thought to predict a clinical benefit to patients.
Bavencio also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
“Today is a significant milestone for people fighting metastatic Merkel cell carcinoma, who until now have not had any options beyond chemotherapy,” said Albert Bourla, Group President, Pfizer Innovative Health in a March 23 press release. “This approval demonstrates the power of collaboration to accelerate meaningful new choices for cancer patients.”
Pleural mesothelioma is a terminal cancer of the lining of the lungs caused by past exposure to asbestos. The cancer is diagnosed in nearly 3000 Americans each year.
For more information about the ongoing JAVELIN clinical trial see ClinicalTrials.gov.
Sources:
- ClinicalTrials.gov
https://clinicaltrials.gov/ct2/results?term=%22malignant+mesothelioma%22&recr=Open&pg=1 - FDA office of hematology and oncology products
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm548278.htm - Albert Bourla, Group President, Pfizer Innovative Health
http://media.emdserono.com/2017-03-23-FDA-Grants-Approval-for-BAVENCIO-R-avelumab-the-First-Immunotherapy-Approved-for-Metastatic-Merkel-Cell-Carcinoma
Nurse Sees Uniqueness in Each of her Mesothelioma Patients
Seeing patients dealing with mesothelioma at different points in their journey reminds me of just how much still needs to be done in the fight against mesothelioma. Within the last few weeks, I have seen newly diagnosed patients who are hard to identify from their loved ones. Who is the patient? All different age ranges, from 29 to 85, men and women, all starting on their journey, all unique people with different stories. What lies ahead for them? No one knows.
The other day I ran into a patient, a young man who was diagnosed and treated 18 months ago. He had surgery followed by many complications and after a prolonged hospital stay he went home with his family. I was unprepared for what he told me, and was surprised by his physical appearance. He was smaller than I remembered, and he was wearing oxygen. As we talked he confided that there was nothing left his medical team could do for him. Then, his next statement keeps playing in my head, “I only have months left.” How sad for him and his loved ones as they face the final part of his journey with mesothelioma.
That same day I ran into a four-year mesothelioma survivor. He looked great, felt well and was enjoying life. Mesothelioma, like all of life, is a different journey for everyone.
Everyday I wake up I feel privileged to care for patients with mesothelioma. Others in the medical community, whether it is researchers, doctors, nurses, or X-ray techs, all hope to make a difference. We believe we do, but sometimes the reminders that people will die from this disease is harsh and heartbreaking.
The statistics are more than that. Behind each number is a person who we have been fortunate to meet and form a relationship with. The journey continues and everyone just wants to enjoy quality time with their loved ones.
Probe May Guide Surgeons to Successful Removal of Mesothelioma Cells
MesotheliomaHelp has reported on numerous attempts by researchers to develop a tool that causes cancer cells to glow allowing surgeons to home in on them during surgery. Now, researchers believe they have developed a probe that will light up cancer cells and give surgeons confidence that they can remove all cancer cells.
Researchers from Michigan Tech focused on beta-galactosidase, a key enzyme with a “long track record in medical science,” according to the researchers. The probe the team developed bonds to the beta-galactosidase leading to a bright glow under fluorescent light.
“Doctors need to pinpoint cancer tissue, but that can be hard,” said Haiying Liu, lead researcher and a chemistry professor at Michigan Technological University. “If we could make beta-galactosidase glow brightly during surgery, it could play a major role in improving outcomes.”
The researchers believe their light-up approach is superior to others for the following reasons:
- The near-infrared glow can penetrate deeper into the tissue giving surgeons a view of tumors underneath healthy tissue.
- The glow is a bright white light and not blue or green like others that can be distracting.
- The fluorescence is “stable and long lasting” making it useful in long cancer surgeries.
Mesothelioma, an unusual form of cancer caused by exposure to airborne asbestos fibers, often has a complex growth pattern making complete surgical removal a very difficult task. Surgeons often have to guess how much tissue to remove, then send samples to the lab for confirmation that they got it all. They also do not want to remove too much healthy tissue. Use of the probe could eliminate guesswork.
“Doctors want to remove all the cancer, but they also don’t want to cut too much,” Liu said. “We want to make their job a little easier.”
Currently, there is no treatment available for mesothelioma that has shown a 100% efficacy rate. Mesothelioma cancer cells have proven to be resistant to the standard treatments of chemotherapy and radiation. While not all mesothelioma patients are candidates for surgery, those who are, may see a higher success rate with surgeons able to pinpoint all cancer cells.
Read the full study in the March 8 issue of the journal Analytic Chimica Acta.
Blood Test Tool For Early Detection of Mesothelioma
MesotheliomaHelp has reported multiple times on the ongoing research to use liquid biopsies or blood samples to detect and manage the treatment of cancer. The non-invasive approach is easier on patients and can return results more quickly. Now, researchers report they have developed a tool that can look at a blood sample and determine whether cancer is present and its point of origin.
Find out more about research using blood tests here and here.
Researchers from The University of California, Los Angeles are using their proprietary tool CancerLocator to detect circulating cell-free DNA and to look at the genome-wide DNA methylation profile to detect cancer, according to a March 24 article in GenomeWeb. The tool, in effect, cross checks the DNA methylation data against a database the team developed that contains information about methylation markers common across cancers and specific to certain tissues, in seven cancers, including lung tissue.
“We have developed a computer-driven test that can detect cancer, and also identify the type of cancer, from a single blood sample,” said lead researcher Jasmine Zhou, Department of Pathology and Laboratory Medicine, David Geffen School of Medicine, UCLA.
During the study, the team found that the CancerLocator outperformed both the random forest and support vector machine standard algorithms in simulated data as well as with live cancer data. The test was also effective for detecting early-stage cancers.
Research shows that metastasis is the cause of nearly 90 percent of cancer deaths. Stopping tumor growth and preventing metastasis is critical, especially for mesothelioma and lung cancer where the diseases are highly aggressive. This can only be achieved if the cancer is detected early.
Mesothelioma, a rare form of cancer caused by past exposure to asbestos, is highly aggressive and is resistant to many cancer treatments making it a difficult disease to treat effectively. The prognosis for mesothelioma patients is usually grim: the average survival time varies from 4 – 18 months after diagnosis. Early detection can mean prolonged survival.
Although there are various cancer screening tools available, such as the colonoscopy for colon cancer, many of the tests are invasive and painful for the patients. However, in this case, there is no reliable method for early detection of the deadly mesothelioma cancer.
Zhou notes that with CancerLocator “the higher the fraction of tumor DNAs in blood, the more accurate the program was at producing a diagnostic result. Therefore, tumors in well-circulated organs, such as the liver or lungs, are easier to diagnose early using this approach than in less-circulated organs such as the breast.”
“The technology is in its infancy and requires further validation, but the potential benefits to patients are huge,” said Zhou.
Each year nearly 3,000 Americans are diagnosed with mesothelioma. The key to increased life expectancy when battling this cancer is early detection.
Read the full study in the March 24 issue of Genome Biology.
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