ORIEN precision cancer initiative designed to do what no single center can achieve alone

The Oncology Research Information Exchange Network precision cancer research collaboration has added three new partners to the team: Rutgers Cancer Institute of New Jersey, Morehouse School of Medicine and University of Southern California Norris Comprehensive Cancer Center.

Michael A. Caligiuri

The collaborative effort, known simply as ORIEN, is designed to enhance precision cancer medicine efforts that are already in place at member organizations through the use of a standard protocol.

So far, more than 130,000 patients have consented to donate their tissue and allow their clinical data to be used for research.

HemOnc Today spoke with Michael A. Caligiuri, MD, director of The Ohio State University Comprehensive Cancer Center and CEO of The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, and William S. Dalton, PhD, MD, CEO of M2Gen, a Moffitt Cancer Center biotechnology company, about how ORIEN has evolved since its launch in May 2014, as well as what future initiatives are planned.

Question: How did ORIEN come about?

William S. Dalton

Dalton: ORIEN was the result of conversations between Dr. Caligiuri and I more than 3 years ago while I was center director of Moffitt Cancer Center. Our intent was to create an organization that would promote data sharing and collaborative research between our institutions and other cancer centers. This began with an effort at Moffitt about 10 years ago that we called Total Cancer Care. Total Cancer Care is a protocol that asks patients for permission to follow them throughout their lifetime, with them donating their clinical data. They also donate their tumor tissue, as well as blood and normal tissue, allowing us to study it using molecular profiling. We put all of that data in a data warehouse so we could study the patients. The patients also allow us to re-contact them if we have questions about how they are doing or if we find something that might benefit them, such as a clinical trial. As large as Moffitt is, we see about 15,000 new patients a year, which is certainly not a large enough population to do this type of effort alone, and we lacked the ability to share data. So, Dr. Caligiuri and I shared the vision of developing a way to utilize the same protocol and procedures to follow patients and learn from them and then openly share data so experts could have access to them. Ultimately, we help more patients this way.

Caligiuri: Dr. Dalton and I both came to the realization that, with the molecular heterogeneity of cancer, no one center would have large numbers of patients with a specific molecular defect. Therefore, to get the right patients with the same genetic or molecular defect to participate in a trial of a targeted agent in a timely fashion, we had to work together and start sharing data with one another. ORIEN allows us to take all of our “haystacks” across a network, quickly find the “needle” in each haystack, put those needles together and conduct the trials in a timely fashion. It also allows researchers to have access to a new, large database with a treasure trove of patient tissues and clinical data to find new targets.

Q: Why were the nine member institutions chosen?

Dalton: Moffit and Ohio State together are the founding members of ORIEN. Not only are we sharing data, but we are creating an environment of collaboration, so we were looking for like-minded institutions that recognized that — no matter how big they are — they cannot generate enough data to pursue a question. It is about big data and, more importantly, it is about sharing these data and also sharing patient tissue to generate data to address complex questions. We are thrilled with the number of institutions that are interested and, in many ways, we can say that they are self-selecting. These institutions saw immediately the value of a uniformed approach to generate data and a uniformed approach to share the data. As you can imagine, when speaking about a large study such as this, there are a lot of regulations. An infrastructure is needed to provide all of these necessary components to make something like this work. This is why M2GEN was formed about 9 years ago when we formed a partnership with Merck to generate large amounts of data. We knew that we needed a workforce totally dedicated to providing the infrastructure for this sort of effort, and this is what M2GEN does for ORIEN. M2Gen is the coordinating center and provides the infrastructure.

Q: What makes this initiative unique?

Dalton: There are several initiatives that are similar but perhaps with a different purpose. To be frank, I think they are all worthy. For example, ASCO’s effort, the CancerLinQ data analytics platform, measures quality with the purpose of trying to learn from each other and improve the quality of care. Ours is more research-based, and as far as I know, we are the only group of cancer centers that use the same protocols [and] the same consent, and we sign a contract that defines how we are going to work together. This includes our ability to share data and collaborate. To my knowledge, I do not know of anything quite like this.

Caligiuri: I believe we may be the only initiative out there that is prospectively consenting our patients, in this case with the Total Cancer Care protocol. We have more than 130,000 patients consented so everyone is fully informed from the get-go. The Total Cancer Care protocol allows us to follow the patient for their lifetime, do whatever we need to do with their tissues to advance cancer research and care, and — perhaps most importantly — to contact them any time we have something that is of value to them or they have something that is of value to us. We have a database that is continually enriched by the care provider and the patient.

Q: How has the initiative evolved since it launched?

Dalton: When we began ORIEN in May 2014, we never imagined we would have 11 members, but we are quite thrilled at how rapidly this has expanded. We are pleased to say that every institution is in the process of opening the protocol, and several have begun enrolling patients. It is no longer a dream — it is actually happening. We have started sharing data on the projects and we have discussed the best ways to match patients to the clinical trials. Members now have the ability to look at limited de-identified data from the 130,000 patients enrolled in Total Cancer Care. Significant progress has been made. We have been able to develop a system that allows all member institutions to examine the data warehouse in real time, so the infrastructure that we all had hoped to build is there.

Caligiuri: We also already have business from pharmaceutical companies. So, we are operational.

Q: Do you anticipate expanding in the near future? Will more institutions join?

Caligiuri: Yes, definitely. Bill and I just spoke with another institution that is interested in joining. We have letters of intent out to six additional institutions that are looking to join ORIEN, so we will continue to grow. The point is that no single center can do this alone in the United States, so ORIEN provides academic and community oncologists an opportunity to participate in something big and important. Cancer centers can incorporate community cancer centers that have the patients but do not have sufficient access to the clinical trials for their patients.

Q: Are there specific cancer types that are the focus of the initiative?

Dalton: We would like to study every cancer, including very rare cancers. Our goal is to be as broad and as inclusive as we can. Our desires are to enroll every patient with cancer so we can learn from everyone. Ultimately, we want to provide information back to patients and their providers so they can use the knowledge that we are generating. The primary goal of this effort is to generate knowledge that is evidence based and can be used for decision-making, not only in research and discovery. Our ultimate goal is to provide evidence-based knowledge at the point of care. The only way you can do this is by studying as many patients as possible. Having said all of this, we are focusing on patients who we believe to have the greatest need of clinical trials. These are patients at highest risk for developing progressive disease and are likely in need of clinical trial. So, although we would like to be as all-inclusive as possible, we are focusing on those patients with the greatest needs.

Q: Do you have any final thoughts?

Dalton: None of us can do this alone, and to truly serve the population we want to serve, we must have the ability to learn from each other. As Mike stated, when you are dealing with rare events, the only way you can make true headway is by coming together to partner with patients using a common protocol and sharing data to pursue important questions. First and foremost, we must share data and we must generate quality data to do this. We not only want to share this, but we want to promote collaborative learning.

Caligiuri: ORIEN provides another opportunity for community oncologists and academic cancer centers to participate in research that will speed up successful cancer drug development. We will have more answers, sooner, for our patients.

For more information:

Michael A. Caligiuri, MD, can be reached at The Ohio State University Comprehensive Cancer Center — Arthur G. James Cancer Hospital and Richard J. Solove Research Institute: 460 W. 10th Ave., Columbus, OH 43210; email: michael.caligiuri@osumc.edu.

William S. Dalton, PhD, MD, can be reached at M2Gen, 10902 N. McKinley Ave., Tampa, FL 33612; email: william.dalton@m2gen.com.

Disclosure: Caligiuri reports no relevant financial disclosures. Dalton reports employment with M2Gen, a for-profit subsidiary of Moffitt Cancer Center.