Message to Pharma: Large Trials in Mesothelioma are Possible

Dr. Lee Krugby Lee Krug, MD, Memorial Sloan Kettering Cancer Center

This month, a notification was sent to investigators on the DETERMINE Trial that accrual will be completed by the end of October. DETERMINE is an international, randomized trial comparing treatment with an immunotherapy drug called tremelimumab to treatment with placebo as second or third line therapy in patients with malignant mesothelioma. The trial opened in May, 2013, and in just 17 months will have enrolled 564 patients! This is a notable achievement. To put this in perspective, the last phase III of this magnitude testing vorinostat in a comparable group of patients (VANTAGE Trial) took 5 1/2 years to enroll 660 patients. There are differences between these two trials that could have accounted, in part, to the more rapid accrual. In DETERMINE, 2/3 of the patients receive the study drug, 1/3 get placebo, while in VANTAGE it was half and half. Also, immunotherapy drugs such as tremelimumab have garnered tremendous excitement in the oncology field due to their promising results in numerous cancers such as melanoma skin cancer and lung cancer. Yet, despite these differences, this accomplishment of completing a trial of this size in such a short period of time should be a wake-up call to the pharmaceutical industry. Historically, drug companies have been reluctant to undertake large trials in mesothelioma due to concerns about feasibility and slow accrual. But this trial demonstrates the potential. Patients with mesothelioma urgently need better treatments, and with only one chemotherapy regimen approved, there is a tremendous opportunity to impact the outcomes for these patients. So here is the message to pharma: Large trials in mesothelioma are possible, and the community of patients with mesothelioma is eager to participate.

Lee M. Krug, MD, is an Associate Attending Physician in the Division of Thoracic Oncology, Department of Medicine at Memorial Sloan-Kettering Cancer Center in New York, New York where he completed a fellowship and chief fellowship in medical oncology. Dr. Krug is the Director of the Mesothelioma Program at Memorial Sloan-Kettering Cancer Center. Read more about Dr. Krug’s work here.

Summary of Mesothelioma Studies Presented at ASCO

Lee M. Krug, MD shares his annual summary of the mesothelioma research presented at the American Society of Clinical Oncology (ASCO) meeting.by Lee M. Krug, MD, Memorial Sloan Kettering Cancer Center

The American Society of Clinical Oncology meeting was held from May 30 – June 3, 2014 in Chicago. This is the largest oncology meeting each year with around 30,000 attendees from all over the globe who congregate to discuss the latest research in all cancer types. I will provide you with my annual summary of the most prominent studies in mesothelioma.

Randomized trial of arginine deprivation with ADI-PEG20: This abstract was presented by Dr. Szlosarek from the United Kingdom. Arginine is an amino acid that normal cells make using an enzyme called ASS (time to make the joke here!). However, many cancer cells lack the ASS enzyme so they cannot make arginine and they need to get it from outside the cell. ADI-PEG20 starves the cancer cells of arginine. In this trial, patients with mesothelioma were randomized to receive treatment with ADI-PEG20 or just supportive care. In order to qualify, the tumor samples were tested to make sure they had low levels of ASS. Side effects were very mild with this treatment. About half of the patients had stabilization of their disease. The time for cancer growth to occur was longer in the ADI-PEG20 arm, but only by a small margin (1.9 versus 3.2 months). A future study will combine ADI-PEG20 with chemotherapy, and that trial should open later this year.

Phase 2 study with tremelimumab: Probably the hottest drugs in oncology right now are the antibodies that boost the immune system. These types of treatment have shown great benefit in melanoma, lung cancer, and many others. Tremelimumab is one of these drugs, and this trial, conducted in Italy by Dr. Calabro and colleagues, showed that mesothelioma also responds to these therapies. Of the 29 patients, 14% of patients had shrinkage of their mesothelioma and 38% had stabilization. These data support the international, randomized trial with tremelimumab that is currently ongoing that will include 542 patients. If this large trial shows that tremelimumab improves survival, this drug will get FDA approval for mesothelioma.

Anti-mesothelin vaccine CRS-207 plus chemotherapy: Dr. Hassan from the National Cancer Institute reported these results. Mesothelin is a protein on the surface of mesothelioma tumors, and seems to be an excellent target for treatment. CRS-207 is a vaccine that increases the immune response against mesothelin. In this study, CRS-207 was given with pemetrexed and cisplatin. Nearly 70% of patients had shrinkage of their cancer, much more than usual with chemotherapy alone, and the responses seemed to last longer. These results should encourage a larger future randomized study.

Next-generation sequencing in mesothelioma: The report from Dr. Scagliotti at the University of Turin, Italy, described his findings from an analysis of gene mutations in a group of mesothelioma tumor samples. This type of testing has become critical for identifying potential targets in all cancers, and customizing treatment for each patient.


Lee M. Krug, MD, is an Associate Attending Physician in the Division of Thoracic Oncology, Department of Medicine at Memorial Sloan-Kettering Cancer Center in New York, New York, where he completed a fellowship and chief fellowship in medical oncology. Dr. Krug is the Director of the Mesothelioma Program at Memorial Sloan-Kettering Cancer Center. He is also the chair of the board of directors of the Meso Foundation.

Update on Mesothelioma: A CancerCare Teleconference

CancerCare Update on MesotheliomaOn Monday, June 30 from 4:30-5:30PM Eastern Time, CancerCare is hosting a free mesothelioma teleconference workshop. The teleconference, titled Update on Mesothelioma, will feature a panel of experts to discuss numerous topics related to the disease. Registrants will be able to listen in on the phone or through a live stream online.

The Update on Mesothelioma teleconference will cover topics including mesothelioma treatment choices; the role of clinical trials; managing side effects, discomfort and pain; communicating with your health care team; quality of life and life style concerns; and physical activity and nutrition issues and tips. Questions for the panel of experts will also be accepted.

The panel of experts consists of four individuals: Richard J. Gralla, MD, FACP, Professor of Medicine, Albert Einstein College of Medicine; Lee M. Krug, MD, Director of the Mesothelioma Program, Associate Attending Physician, Division of Thoracic Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center; Mary Hesdorffer, MS, APRN-BC, Nurse Practitioner, Executive Director, Mesothelioma Applied Research Foundation; and Winfield Boerckel, MSW, MBA, Director of Social Service – Long Island, Lung Cancer Program Coordinator, CancerCare.

Mary Hesdorffer, MS, APRN-BC, is an expert nurse practitioner with over 16 years of experience in mesothelioma treatment and dozens of published articles in a variety of scientific journals. She is the executive director of the Meso Foundation and the first line of help for patients and caregivers faced with a mesothelioma diagnosis.

Lee M. Krug, MD, is an Associate Attending Physician in the Division of Thoracic Oncology, Department of Medicine at Memorial Sloan-Kettering Cancer Center in New York, New York, where he completed a fellowship and chief fellowship in medical oncology. Dr. Krug is the Director of the Mesothelioma Program at Memorial Sloan-Kettering Cancer Center. He is also the chair of the board of directors of the Meso Foundation.

To register for the free Update on Mesothelioma teleconference workshop, visit CancerCare.org.

Regional Conference on Malignant Mesothelioma: Destination New York

NewYorkSkyline

All of us at the Meso Foundation have been very aware of the need mesothelioma patients and families have to connect with others facing similar challenges, and learn about their disease and its treatment options.

For this reason, for the second consecutive year, we are organizing a regional conference taking place in New York City.

On Friday, September 27, at 9 AM, please join us at the Harvard Club for this one-day conference on malignant mesothelioma for patients, their families, doctors, and others wishing to learn more about this disease. The conference is supported by an educational grant from Levy Phillips & Konigsberg, LLP.

We put together an impressive line-up of mesothelioma experts from the New York area who will discuss topics including standard treatments, ongoing research, environmental/occupational exposure risk, and legal implications. Read the agenda here. 


Register

You can watch below our last year’s conference:

The cost to register is $25 per person (includes all sessions, breakfast and lunch). You may register by visiting curemeso.org/knowledge or by calling the Meso Foundation at (703) 879-3797. Registration fees will be donated back to the Meso Foundation. Availability is limited. You must register before our deadline of September 10.

If you are traveling to the conference and need a hotel room, we put together a list of hotels available nearby. Due to the Clinton Global Initiative annual meeting taking place around the same time as our conference, the hotels near the Harvard Club and throughout New York City could be very expensive, so make sure you book early.