BREAKING NEWS: Data Released from Anetumab Ravtansine Study

VaccineLast week, at the World Conference on Lung Cancer, Dr. Raffit Hassan presented promising data on a novel agent, anetumab ravtansine, also known as BAY 94-9343. Anetumab ravtansine is an antibody-drug conjugate directed against the target molecule mesothelin which is highly expressed on mesotheliomas.

“Anetumab ravtansine shows encouraging efficacy in patients with advanced mesothelioma which warrants further study,” stated Dr. Hassan, a senior investigator and the head of the Thoracic and Solid Tumor Immunotherapy Section at the National Cancer Institute who has been working on developing mesothelin targeted therapies for patients with mesothelioma and other cancers for the last two decades.

This was a phase I study to determine the safety and activity of anetumab ravtansine in patients with cancer who had failed standard therapies. Based on early results of this trial more mesothelioma patients were enrolled to better define the activity of this drug in patients with pleural mesothelioma who had progressed on chemotherapy. Out of the 16 mesothelioma patients treated at the maximum tolerated dose, 5 (31%) had objective tumor shrinkage while 7 (44%) had stable disease. However, out of the 10 mesothelioma patients who received anetumab ravtansine as second line therapy 5 (50%) had objective tumor shrinkage and 4 (40%) had stable disease. In most patients the tumor response was very durable with three patients still receiving the drug more than 2 years after starting therapy.

Antibody-drug conjugates (also known as ADCs) are a new class of drugs that function by linking a particular antibody to a cancer-fighting drug. When combined, the antibody precisely targets the cancer cell, delivering the drug directly to it, thus avoiding extensive damage to healthy cells typical of traditional chemotherapies.

Using Situational Awareness on the Jobsite

Construction SiteIn part one and part two of the situational awareness blog series, we defined situational awareness and referenced its use in do-it-yourself projects. In this final installment of the series, we discuss how the use of situational awareness can save lives on the jobsite.

Most of us take on the responsibility of a job or career knowing that we will spend approximately eight hours per day on the jobsite. Each day, as we enter our jobsite, many of us proceed directly to our workspace without being aware of what is happening around us. Just as situational awareness (SA) can save our lives in daily situations, SA can save our lives on the job.

You may find yourself in a situation in which you are working in an area that may present the possibility of airborne exposures to harmful materials, such as asbestos. You may not be in direct contact with asbestos, but you may be in close proximity to an area where a possible asbestos containing material (ACM) is being disturbed, putting you at risk of exposure.

The jobsite pictured above contains many possible exposures, as many tasks are happening simultaneously.

When you enter a jobsite such as the one pictured, it is important to use situational awareness and take the first few moments on the site to focus on yourself and your safety. For example, first responders are trained to use situational awareness every time they are called, and they are required to use the first 10-30 seconds upon entering a scene to focus on themselves and how their surroundings may affect them.

The first few moments on the jobsite should be spent evaluating your surroundings, observing the tasks that are happening, materials that are being used, potential byproducts being created, workers that are in the area, and machinery that is present. If you have any questions from this evaluation period, do not start working until you have spoken with your immediate supervisor.

Today, workers have adopted a “Safety Culture” thought process. Situational awareness is an important piece of this culture. Examples include:

  1. Complex situations are better thought out
  2. Chains of command are established
  3. Toxic exposures are reduced
  4. There is less fear of job hazards and toxic exposures
  5. An emergency plan is thought out

A few of the positive outcomes from incorporating SA into your daily work schedule are:

  1. A safer work environment
  2. Less toxic exposures
  3. Proactive, NOT reactive, decision making
  4. Cost savings for your employers
  5. Healthier employees

To learn more about utilizing situational awareness, please read part one of this blog series. For information regarding the use of situational awareness during do-it-yourself projects, please read part two.

The Meso Foundation Congratulates Dr. Harvey Pass on Prestigious Award

Harvey PassThe Meso Foundation congratulates Dr. Harvey Pass for receiving the Merit Award from the International Association for the Study of Lung Cancer (IASLC).

Dr. Pass is Vice Chair for Research in the Department of Cardiothoracic Surgery at New York University Langone Medical Center and the Stephen E. Banner Professor of Thoracic Oncology. His participation in IASLC, which began in 1995, has included a role as a member of IASLC’s Scientific Program Committee and its Board of Directors, chair of the Publications Committee, associate editor for the Journal of Thoracic Oncology and executive editor of The IASLC’s Multidisciplinary Approach to Thoracic Onocology.

Dr. Pass is also a founder of the Mesothelioma Applied Research Foundation, as well as a former board member of the same. He has participated in numerous conferences organized by the Meso Foundation, including the International Symposium on Malignant Mesothelioma, and has, on numerous occasions, presented his expertise and findings to the mesothelioma community.

“Dr. Pass has been a leader in the field of mesothelioma and a vocal advocate for mesothelioma patients,” said Mary Hesdorffer, nurse practitioner and executive director of the Meso Foundation. “We are profoundly grateful for his contributions to the field of the mesothelioma and his desire to do well for mesothelioma patients.”

Pharmaceutical Company Completes Enrollment for Phase 1B Trial for Mesothelioma

ResearcherIf you attended our International Symposium on Malignant Mesothelioma in March of this year, you may recall the buzz of excitement that coursed throughout the scientific sessions. This buzz sparked excitement throughout the entire mesothelioma community, as we discussed advances in science, the needs of those affected by this disease, and the work being done to spur the movement of drugs through the clinical trial process.

Recently, Aduro Biotech issued a press release announcing the completion of enrollment in the Phase 1b clinical trial of its novel immunotherapy, CRS-207. I took the opportunity to call and congratulate Steve Isaacs, the chairman, president, and CEO of Aduro Biotech, on his initial trial results and his plan to move this drug along quickly and offer it globally in the Phase 3 setting.

It is exciting to see plans to jump from a Phase 1b directly to Phase 3 based on what was agreed to be compelling data by the FDA.

Patients treated on the Phase 1b study received 2 doses of CRS-207, a vaccine that utilizes the listeria virus and mesothelin as a target to gain entry into the cell. Patients then went on to receive standard of care pemetrexed/cisplatin every three weeks for 6 courses. If patients were stable or responded to the aforementioned therapy, they were then placed on a maintenance regimen of vaccinations every 8 weeks until progression.

Interim data was presented at a large scientific conference and demonstrated that in the 32 evaluable patients treated on this clinical trial, disease control was observed in 94%, which included a 60% partial response, and 34% experiencing stable disease.

The study will remain open to chemotherapy naive patients (patients who have never received chemotherapy for their mesothelioma) while the plans for the Phase 3 trial continue.

To read more about the CRS-207 study results, click here. To listen to an interview that we held with Steve Isaacs regarding the CRS-207 clinical trial, click here.

Using Herbs and Dietary Supplements During Mesothelioma Treatment

SpicesOver the last several year or so, a number of people have posted information about various supplements they favor, both for general health and, occasionally, as specific alternative remedies meant to bolster cancer treatment or prevention.  A number of our mesothelioma warriors have used yoga or stretching regimens to aid in post-surgical tissue relaxation, and others employ meditation or focused cognition to aid in mood and pain management. These non-invasive techniques have conferred varying levels of positive results, and pose no particular interactive problems with standard oncology therapy. Others, however, use one or more complementary therapies (e.g., naturopathy, homeopathy) or supplements (e.g., ginseng, green tea extracts), which could cause interactions with standard treatment if the proper care is not taken. Here, we provide some reference material to help anyone considering using such therapies or supplements.

A wealth of reputable and relevant information is easily available. For example, the professionals at Memorial Sloan Kettering Cancer Center (MSKCC) have a botanical expert pharmacist who monitors current science regarding herbs, botanicals, and other supplements. This is part of MSKCC’s Integrative Medicine Services. More information is available here.

Some herbs and dietary supplements are known to be detrimental to standard cancer treatment efficacy. One thing all reliable sources agree upon is that, before you start using any form of supplement or complementary medical treatment, you should tell your physician what you are considering.

MSKCC writes: “It’s important to tell your doctor or another qualified professional that you are using a dietary supplement. The reason for this is that an active ingredient in the product could interact with — increase or lessen — the effect of other medicines you’re taking.  People undergoing treatment for cancer should not receive any dietary supplements unless they’re prescribed by a doctor or given as part of a clinical trial that’s received [IRB] approval.”

NCI, in its Complimentary Alternative Medicine material, agrees: “Tell your doctor if you’re taking any dietary supplements, no matter how safe you think they are. This is very important. Even though there may be ads or claims that something has been used for years, they do not prove that it’s safe or effective.”

MD Anderson is in line in this herbal supplements article: “[Y]ou should approach herbal supplements with caution and speak with your doctor before taking any, whether you’re considering a pill, capsule, tablet or liquid form.”

The second important thing each of these expert facilities makes clear is that supplements – including herbs, vitamins, manufactured powdered weight controls, steroids, and all other over-the-counter materials are unregulated. The FDA treats supplements as foods. This means it does not verify any label claims (other than prohibiting specific disease prevention assertions). These materials are not subjected to clinical trials as they are understood in pharmaceutical development, and there is no control over additives, purity or the production methods.

Some manufacturers’ studies assert benefits in cancer treatment from use of their supplements. However, these are not the randomized, double blind studies we know as the gold standard for scientific study of new therapies. NCI and the National Center for Complementary and Integrative Health have begun clinical trials on a limited number of complementary therapies, but that data is still in development. The list and overview of these studies is available here.

If your research and medical team’s review lead you to try any of the hundreds of supplements advertised as health support, it is sensible to begin with a minimum dose. If the herb or compound neither helps nor hurts, you can slowly increase the amount or frequency of use. A measured approach will give you, and the physicians checking your blood analyses and scans, a better opportunity to detect any adverse effects before they become severe. Similarly, you can determine whether positive effects are amplified by increased dosage.

The following resources can provide you with additional information:

To read more about complementary and alternative medicine pertaining to mesothelioma patients, click here.